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Neurovegetative Decoupling in Somatoform Disorders : Biofeedback Interest (BIOFEESOMATO)

Primary Purpose

Somatoform Disorders, Irritable Bowel Syndrome, Psychogenic Non-Epileptic Seizure

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Heart rate variability Biofeedback [HRV-BFB]
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Somatoform Disorders focused on measuring Autonomic nervous system, Brain-gut axis, Endophenotype, Cognitive-emotional vulnerability, Traumas, Biofeedback, Heart rate variability, Vagal tone, Central nervous system, Enteric nervous system, Early life events, Somatoform disorders, Stress, Irritable bowel syndrome, Psychogenic non epileptic seizures

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Somatoform disorders (IBS or PNES) diagnosis must be established by the partner doctors
  • Participants must have home computer
  • Participants must be of the age of majority
  • Participants must be registered for social security
  • Participants must have signed an informed consent

Exclusion Criteria:

  • Specially protected participants (under clauses L1121-5 and L1121-8 by the code of public health): juveniles, pregnant womens, nursing mothers, law's protection peoples
  • Participants suffering from a severe psychiatric disease needing specialised attention
  • Participants suffering from or have suffered from a severe disease causing autonomic dysfunctions (heart failure, asthma, blood disease, renal failure, peripheral neuropathy, vagotomy, thyroid disorder, alcoholism, liver disease, amyloidosis)
  • Participants taking medication which could be impact autonomic nervous system activity (anticholinergic, antiarrhythmics, clonidine, beta-blockers, tricyclic anti-depressants, metronidazole)
  • Participants placing under judicial or administrative supervisions
  • Participants were compensated more than 4500 euros because of his research protocol participation concerning human over the 12 months prior to the actual study
  • Participants being not be able to contact in emergency
  • Participants being in an exclusion period from another study

Sites / Locations

  • University Hospital, Grenoble AlpesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group (BFB training)

Control group (no BFB training)

Arm Description

The participants assigned to the experimental group will do the biofeedback training using the Emwave software during the intervention period (T2-T3). The biofeedback software (Emwave Pro®) includes a photoplethysmography sensor that can be positioned on the earlobe. The installation of the program and the explanations needed for using it, will be done during the second session (T2). According to the guidelines, a fractional training is proposed 5 minutes, 3 times a day for 24 days (T2-T3).

The participants assigned to the experimental group will not do a specific exercise during the intervention period (T2-T3).

Outcomes

Primary Outcome Measures

High frequency [HF] (0.15-0.40 Hz)
High frequency (0.15-0.40 Hz), frequency-domain parameter HF will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
High frequency [HF] (0.15-0.40 Hz)
High frequency (0.15-0.40 Hz), frequency-domain parameter HF will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
High frequency [HF] (0.15-0.40 Hz)
High frequency (0.15-0.40 Hz), frequency-domain parameter HF will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Root mean square of successive RR interval differences [RMSSD]
Root mean square of successive RR interval differences, temporal-domain parameter RMSSD will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Root mean square of successive RR interval differences [RMSSD]
Root mean square of successive RR interval differences, temporal-domain parameter RMSSD will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Root mean square of successive RR interval differences [RMSSD]
Root mean square of successive RR interval differences, temporal-domain parameter RMSSD will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].

Secondary Outcome Measures

Low frequency [LF] (0.04-0.15 Hz)
Low frequency (0.04-0.15 Hz), frequency-domain parameter LF will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Low frequency [LF] (0.04-0.15 Hz)
Low frequency (0.04-0.15 Hz), frequency-domain parameter LF will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Low frequency [LF] (0.04-0.15 Hz)
Low frequency (0.04-0.15 Hz), frequency-domain parameter LF will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Low frequency [LF] 0.1 Hertz (0.075-0.108Hz)
Spectral power of the low-frequency 0.1Hz band (0.075-0.108Hz), frequency-domain parameter LF-0.1Hz will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Low frequency [LF] 0.1 Hertz (0.075-0.108Hz)
Spectral power of the low-frequency 0.1Hz band (0.075-0.108Hz), frequency-domain parameter LF-0.1Hz will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Low frequency [LF] 0.1 Hertz (0.075-0.108Hz)
Spectral power of the low-frequency 0.1Hz band (0.075-0.108Hz), frequency-domain parameter LF-0.1Hz will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Total power (0-0.40 Hz)
Total power of the 0-0.40 Hertz band, frequency-domain parameter Total power will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Total power (0-0.40 Hz)
Total power of the 0-0.40 Hertz band, frequency-domain parameter Total power will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Total power (0-0.40 Hz)
Total power of the 0-0.40 Hertz band, frequency-domain parameter Total power will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Ratio Low frequency / High frequency [LF / HF]
Ratio of LF to HF power, frequency-domain parameter LF/HF will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Ratio Low frequency / High frequency [LF / HF]
Ratio of LF to HF power, frequency-domain parameter LF/HF will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Ratio Low frequency / High frequency [LF / HF]
Ratio of LF to HF power, frequency-domain parameter LF/HF will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Standard deviation of all NN intervals [SDNN]
Standard deviation of all NN intervals, temporal-domain parameter SDNN will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Standard deviation of all NN intervals [SDNN]
Standard deviation of all NN intervals, temporal-domain parameter SDNN will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Standard deviation of all NN intervals [SDNN]
Standard deviation of all NN intervals, temporal-domain parameter SDNN will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Skin conductance responses [SCR] frequency
Skin conductance responses [SCR] frequency : number of the spontaneous galvanic skin responses by periods SCR will be measured using the Galvanic skin responses [GSR]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).
Skin conductance responses [SCR] frequency
Skin conductance responses [SCR] frequency : number of the spontaneous galvanic skin responses by periods SCR will be measured using the Galvanic skin responses [GSR]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).
Skin conductance responses [SCR] frequency
Skin conductance responses [SCR] frequency : number of the spontaneous galvanic skin responses by periods SCR will be measured using the Galvanic skin responses [GSR]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).
Skin conductance responses [SCR] amplitude
Skin conductance responses amplitude: amplitude of the spontaneous galvanic skin responses by periods SCR will be measured using the Galvanic skin responses [GSR]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).
Skin conductance responses [SCR] amplitude
Skin conductance responses amplitude: amplitude of the spontaneous galvanic skin responses by periods SCR will be measured using the Galvanic skin responses [GSR]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).
Skin conductance responses [SCR] amplitude
Skin conductance responses amplitude: amplitude of the spontaneous galvanic skin responses by periods SCR will be measured using the Galvanic skin responses [GSR]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).
Integrated skin conductance responses [ISCR]
Integrated skin conductance responses [ISCR]: area of the galvanic skin responses identified on the signal ISCR will be measured using the Galvanic skin responses [GSR]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).
Integrated skin conductance responses [ISCR]
Integrated skin conductance responses [ISCR]: area of the galvanic skin responses identified on the signal ISCR will be measured using the Galvanic skin responses [GSR]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).
Integrated skin conductance responses [ISCR]
Integrated skin conductance responses [ISCR]: area of the galvanic skin responses identified on the signal ISCR will be measured using the Galvanic skin responses [GSR]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).
Pulsatility index variation [PI]
Pulsatility index variation [PI] : transit time flow PI will be measured using the Photoplethysmography [PPG]: PPG data will be recorded using a finger sensor. Physiological data recorded are related to the adrenergic sympathetic tone and allowing a record of the blood pulse waves associated with the heart rate.
Pulsatility index variation [PI]
Pulsatility index variation [PI] : transit time flow PI will be measured using the Photoplethysmography [PPG]: PPG data will be recorded using a finger sensor. Physiological data recorded are related to the adrenergic sympathetic tone and allowing a record of the blood pulse waves associated with the heart rate.
Pulsatility index variation [PI]
Pulsatility index variation [PI] : transit time flow PI will be measured using the Photoplethysmography [PPG]: PPG data will be recorded using a finger sensor. Physiological data recorded are related to the adrenergic sympathetic tone and allowing a record of the blood pulse waves associated with the heart rate.
Breathing rate
Breathing rate by cycles per minute The breathing rate will be measured using a breathing belt.
Breathing rate
Breathing rate by cycles per minute The breathing rate will be measured using a breathing belt.
Breathing rate
Breathing rate by cycles per minute The breathing rate will be measured using a breathing belt.
Dominant power (0-0.15Hz)
Dominant power of the 0-0.15 Hertz band, frequency-domain parameter Dominant power will be measured using the electrogastrogram [EGG]: EGG data will be recorded using 6 single use and adhesive electrodes placed on the skin of the abdomen.
Dominant power (0-0.15Hz)
Dominant power of the 0-0.15 Hertz band, frequency-domain parameter Dominant power will be measured using the electrogastrogram [EGG]: EGG data will be recorded using 6 single use and adhesive electrodes placed on the skin of the abdomen.
Dominant power (0-0.15Hz)
Dominant power of the 0-0.15 Hertz band, frequency-domain parameter Dominant power will be measured using the electrogastrogram [EGG]: EGG data will be recorded using 6 single use and adhesive electrodes placed on the skin of the abdomen.
Total power (0-0.15Hz)
Total power of the 0-0.15 Hertz band, frequency-domain parameter Total power will be measured using the electrogastrogram [EGG]: EGG data will be recorded using 6 single use and adhesive electrodes placed on the skin of the abdomen.
Total power (0-0.15Hz)
Total power of the 0-0.15 Hertz band, frequency-domain parameter Total power will be measured using the electrogastrogram [EGG]: EGG data will be recorded using 6 single use and adhesive electrodes placed on the skin of the abdomen.
Total power (0-0.15Hz)
Total power of the 0-0.15 Hertz band, frequency-domain parameter Total power will be measured using the electrogastrogram [EGG]: EGG data will be recorded using 6 single use and adhesive electrodes placed on the skin of the abdomen.
Slow-waves frequency (physiological outcome)
Slow-waves frequency per minute, frequency-domain parameter Slow-wave frequency will be measured using the electrogastrogram [EGG]: EGG data will be recorded using 6 single use and adhesive electrodes placed on the skin of the abdomen.
Slow-waves frequency (physiological outcome)
Slow-waves frequency per minute, frequency-domain parameter Slow-wave frequency will be measured using the electrogastrogram [EGG]: EGG data will be recorded using 6 single use and adhesive electrodes placed on the skin of the abdomen.
Slow-waves frequency (physiological outcome)
Slow-waves frequency per minute, frequency-domain parameter Slow-wave frequency will be measured using the electrogastrogram [EGG]: EGG data will be recorded using 6 single use and adhesive electrodes placed on the skin of the abdomen.
Delta frequency (0-4Hz)
Delta frequency 0-4 Hertz band Delta frequency will be measured using the electroencephalogram [EEG]: EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Delta frequency (0-4Hz)
Delta frequency 0-4 Hertz band Delta frequency will be measured using the electroencephalogram [EEG]: EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Delta frequency (0-4Hz)
Delta frequency 0-4 Hertz band Delta frequency will be measured using the electroencephalogram [EEG]: EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Theta frequency (4-7Hz)
Theta frequency 4-7 Hertz band Theta frequency will be measured using the electroencephalogram [EEG]: EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Theta frequency (4-7Hz)
Theta frequency 4-7 Hertz band Theta frequency will be measured using the electroencephalogram [EEG]: EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Theta frequency (4-7Hz)
Theta frequency 4-7 Hertz band Theta frequency will be measured using the electroencephalogram [EEG]: EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Alpha frequency (8-12Hz)
Alpha frequency 8-12 Hertz band Alpha frequency will be measured using the electroencephalogram [EEG]: EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Alpha frequency (8-12Hz)
Alpha frequency 8-12 Hertz band Alpha frequency will be measured using the electroencephalogram [EEG]: EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Alpha frequency (8-12Hz)
Alpha frequency 8-12 Hertz band Alpha frequency will be measured using the electroencephalogram [EEG]: EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Beta frequency (13-30Hz)
Beta frequency 13-30 Hertz band Beta frequency will be measured using the electroencephalogram [EEG]: EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Beta frequency (13-30Hz)
Beta frequency 13-30 Hertz band Beta frequency will be measured using the electroencephalogram [EEG]: EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Beta frequency (13-30Hz)
Beta frequency 13-30 Hertz band Beta frequency will be measured using the electroencephalogram [EEG]: EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Gamma frequency (>30Hz)
Gamma frequency >30 Hertz band Gamma frequency will be measured using the electroencephalogram [EEG]: EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Gamma frequency (>30Hz)
Gamma frequency >30 Hertz band Gamma frequency will be measured using the electroencephalogram [EEG]: EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Gamma frequency (>30Hz)
Gamma frequency >30 Hertz band Gamma frequency will be measured using the electroencephalogram [EEG]: EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Alexithymia score
Alexithymia score will be measured using the Bermond-Vorst Alexithymia Questionnaire B version (BVAQ-B; Vorst & Bermond, 2001; French version Deborde et al., 2004). The subscale as considered as a trait scale including 20 items.
Neuroticism score
Neuroticism score will be measured using the Big Five Inventory-Neuroticism (BFI-N; John et al., 1991; French version Plaisant et al., 2005). The subscale as considered as a trait scale including 8 items.
Trait and state anxiety scores
The trai and state anxiety scores will be measured using the State-Trait Anxiety Inventory (STAI Y-AB) (Spielberger et al., 1983; French version Bruchon-Schweitzer & Paulhan, 1990). The scale includes 40 items.
Style of coping
The style of coping will be measured using the Brief Cope (Carver, 1997; French version Muller & Spitz, 2003). We will use it in its trait version. The subscale as considered as a trait scale including 28 items.
Positive affectivity score
Positive affectivity score will be measured using the Positive And Negative Affect Schedule (PANAS; Watson et al., 1988; French version Caci & Bayle, 2007). To measure a global affective state, a score of positivity will be calculated by subtracting negative affect score from positive affect score. The subscale as considered as a state scale including 20 items.
Positive affectivity score
Positive affectivity score will be measured using the Positive And Negative Affect Schedule (PANAS; Watson et al., 1988; French version Caci & Bayle, 2007). To measure a global affective state, a score of positivity will be calculated by subtracting negative affect score from positive affect score. The subscale as considered as a state scale including 20 items.
Positive affectivity score
Positive affectivity score will be measured using the Positive And Negative Affect Schedule (PANAS; Watson et al., 1988; French version Caci & Bayle, 2007). To measure a global affective state, a score of positivity will be calculated by subtracting negative affect score from positive affect score. The subscale as considered as a state scale including 20 items.
Depressive symptoms score
The depressive symptoms score will be measured using the Center for Epidemiologic Studies-Depression Scale (CES-D; Radloff, 1977; French version Führer & Rouillon, 1989). The subscale as considered as a state scale including 20 items.
Depressive symptoms score
The depressive symptoms score will be measured using the Center for Epidemiologic Studies-Depression Scale (CES-D; Radloff, 1977; French version Führer & Rouillon, 1989). The subscale as considered as a state scale including 20 items.
Depressive symptoms score
The depressive symptoms score will be measured using the Center for Epidemiologic Studies-Depression Scale (CES-D; Radloff, 1977; French version Führer & Rouillon, 1989). The subscale as considered as a state scale including 20 items.
Perceived-stress level
The perceived-stress level will be measured using the Perceived Stress Scale (PSS; Cohen et al., 1983; French version Bellighausen et al., 2009). The subscale as considered as a state scale including 10 items.
Perceived-stress level
The perceived-stress level will be measured using the Perceived Stress Scale (PSS; Cohen et al., 1983; French version Bellighausen et al., 2009). The subscale as considered as a state scale including 10 items.
Perceived-stress level
The perceived-stress level will be measured using the Perceived Stress Scale (PSS; Cohen et al., 1983; French version Bellighausen et al., 2009). The subscale as considered as a state scale including 10 items.
Coping flexibility
The coping flexibility score will be measured using the Coping Flexibility Scale (CFS; Kato, 2012). The CFS measures the coping flexibility including 10 items. The subscale as considered as a state scale.
Coping flexibility
The coping flexibility score will be measured using the Coping Flexibility Scale (CFS; Kato, 2012). The CFS measures the coping flexibility including 10 items. The subscale as considered as a state scale.
Coping flexibility
The coping flexibility score will be measured using the Coping Flexibility Scale (CFS; Kato, 2012). The CFS measures the coping flexibility including 10 items. The subscale as considered as a state scale.
Metacoping
The metacoping score will be measured using a visual analogue scale (VAS). The VAS was developed by ourselves to measure the perceived effectiveness of coping by asking: " how strategies used by yourself to cope with the situation were efficient? ". The participants will have to rate from 0 (no efficacy) to 10 (maximum of efficacy). The subscale as considered as a state scale.
Metacoping
The metacoping score will be measured using a visual analogue scale (VAS). The VAS was developed by ourselves to measure the perceived effectiveness of coping by asking: " how strategies used by yourself to cope with the situation were efficient? ". The participants will have to rate from 0 (no efficacy) to 10 (maximum of efficacy). The subscale as considered as a state scale.
Metacoping
The metacoping score will be measured using a visual analogue scale (VAS). The VAS was developed by ourselves to measure the perceived effectiveness of coping by asking: " how strategies used by yourself to cope with the situation were efficient? ". The participants will have to rate from 0 (no efficacy) to 10 (maximum of efficacy). The subscale as considered as a state scale.
Social support score
The social support score will be measured using the Social Support Questionnaire short version (SSQ6; Sarason et al., 1987a; French version Bruchon-Schweitzer et al., 2003). The subscale as considered as a trait scale including 6 items.
Interceptive sensitivity score
The interceptive sensitivity score will be measured using the Multidimensional Assessment of Interoceptive Awareness second version (MAIA-2; Mehling et al., 2018). The subscale as considered as a trait scale including 37 items.
Life satisfaction score
The life satisfaction score will be measured using the Satisfaction With Life Scale (SWLS; Diener et al., 1985; French version Blais et al., 1989). The subscale as considered as a state scale including 5 items.
Life satisfaction score
The life satisfaction score will be measured using the Satisfaction With Life Scale (SWLS; Diener et al., 1985; French version Blais et al., 1989). The subscale as considered as a state scale including 5 items.
Life satisfaction score
The life satisfaction score will be measured using the Satisfaction With Life Scale (SWLS; Diener et al., 1985; French version Blais et al., 1989). The subscale as considered as a state scale including 5 items.
Negative impact scores
The negative impact score will be measured using the Life Experiences Survey (LES; Sarason et al., 1978). The subscale as considered as a trait scale including 50 items. In this study a modified version of the LES will be used, whereby subjects documented the presence and perceived impact of adulthood life events that had occurred since 18 years of age to the time of completion of the survey. For the purposes of this study, 3 scores will be generated from this survey: the number of negatively perceived life events, the negative impact score determined by the sum of the impact scores of negatively perceived life events alone (higher scores indicate greater negative impact), and the total impact score determined by the sum of the impact scores of both negatively and positively perceived life events (higher scores indicate an overall more positive impact and lower scores indicate an overall more negative impact of all adulthood life events).
Frequency, severity and intensity scores
The frequency, severity and intensity scores will be measured using the Daily Hassles Scale (DHS; Kanner et al., 1981). The subscale as considered as a trait scale including 117 items.
Child Abuse scores
The child abuse scores will be measured using the Childhood Trauma Questionnaire-Short Form (CTQ; Bernstein et al., 2003). The subscale as considered as a trait scale including 28 items.
Acceptance score
The acceptance score will be measured using the Illness Cognition Questionnaire for chronic disease (ICQ-18; Evers et al., 2001). The subscale as considered as a state scale including 18 items.
Acceptance score
The acceptance score will be measured using the Illness Cognition Questionnaire for chronic disease (ICQ-18; Evers et al., 2001). The subscale as considered as a state scale including 18 items.
Acceptance score
The acceptance score will be measured using the Illness Cognition Questionnaire for chronic disease (ICQ-18; Evers et al., 2001). The subscale as considered as a state scale including 18 items.

Full Information

First Posted
March 1, 2021
Last Updated
May 10, 2023
Sponsor
University Hospital, Grenoble
Collaborators
Laboratoire de Psychologie et NeuroCognition, Laboratoire interuniversitaire de psychologie : personnalité, cognition et changement social - LIP-PC2S
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1. Study Identification

Unique Protocol Identification Number
NCT04807933
Brief Title
Neurovegetative Decoupling in Somatoform Disorders : Biofeedback Interest
Acronym
BIOFEESOMATO
Official Title
Neurovegetative Decoupling in the Visceral-brain Axis and Cognitive-emotional Vulnerability in Somatoform Disorders : Interest of Vagal Biofeedback
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Grenoble
Collaborators
Laboratoire de Psychologie et NeuroCognition, Laboratoire interuniversitaire de psychologie : personnalité, cognition et changement social - LIP-PC2S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Evaluation of the physiological and clinical effects of the biofeedback training with patients suffering from somatoform disorders, depending on their neurovegetative profile related to a visceral-brain decoupling.
Detailed Description
Somatoform disorders [SD] are defined as physiological function or organ disturbances unexplained by a specific diagnosis criterion. Some approaches have recently defended the idea of common factors of vulnerability behind the large variability of the clinical symptoms regarding the SD. In this context, the lead of the neurovegetative disturbances started receiving attention following some studies that suggested the autonomic nervous system [ANS] disturbances concerning a somatoform disorder, independently of its form. Two different neurovegetative endophenotypes (individual autonomic profiles) were highlighted: a functional neurovegetative profile (high vagal tone) and a dysfunctional neurovegetative profile (low vagal tone). A dysfunctional neurovegetative profile could be accompanied by a chronic decoupling in the brain-visceral axis according as the ANS is considered as a bidirectional communication system linked the central nervous system [CNS] and the viscera. Depending on the types of the neurovegetative profiles, different degrees of cognitive-emotional vulnerability and a higher or a lower level of acceptance of the illness could be supposed. Finally, recent findings defend the idea of the traumatic experiences as a determining factor to develop a SD. In accordance to the last notions regarding the SD, some therapeutic approaches could be interesting specifically techniques focusing on the vagal nerve. In this context, biofeedback [BFB] could provide a powerful method to restore the clinical and physiological impairments. As a consequence, the main objective is to evaluate the physiological and clinical effects of the BFB training with patients suffering from SD: Irritable Bowel Syndrome [IBS] or Psychogenic Non Epileptic Seizure [PNES]. The investigators make the prediction that the patients will be more or less responding to the biofeedback depending on their neurovegetative profile. A clustering will be performed in advance to identify the patients having a dysfunctional neurovegetative profile and patients having a functional neurovegetative profile. It will also permit to the investigators to confirm the hypothesis about the existence of two neurovegetative profiles related to a visceral-brain decoupling concerning the SD, independently of its form. To attest to it, 2 types of somatoform disorders will be analyzed: the irritable bowel syndrome manifesting by peripheral symptoms and the psychogenic non-epileptic seizures manifesting by central symptoms. Then the investigators will carry out a psycho-social exploration to demonstrate a higher cognitive-emotional vulnerability and a higher traumatic event incidence in this particular population, depending on their autonomic profiles.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Somatoform Disorders, Irritable Bowel Syndrome, Psychogenic Non-Epileptic Seizure
Keywords
Autonomic nervous system, Brain-gut axis, Endophenotype, Cognitive-emotional vulnerability, Traumas, Biofeedback, Heart rate variability, Vagal tone, Central nervous system, Enteric nervous system, Early life events, Somatoform disorders, Stress, Irritable bowel syndrome, Psychogenic non epileptic seizures

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study requires 3 sessions (T1 / T2 / T3) with at least 24 days between each. The period (24 days) between the first session and the second session (T1-T2) will be considered as the control period. During the period, the participants will practice none exercise. The period (24 days) between the second session and the third session (T2-T3) will be considered as the intervention period. At the end of the second session (T2), the participants will be separated into two inter-subject groups: an experimental group performing BFB technique (3X5 min per day) in the intervention period (T2-T3) and a control group not performing a specific exercise in the intervention period (T2-T3).
Masking
Participant
Masking Description
The participants won't be informed of the condition to which they belong. A debriefing will be done at the end of the last session (T3) for each participant.
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group (BFB training)
Arm Type
Experimental
Arm Description
The participants assigned to the experimental group will do the biofeedback training using the Emwave software during the intervention period (T2-T3). The biofeedback software (Emwave Pro®) includes a photoplethysmography sensor that can be positioned on the earlobe. The installation of the program and the explanations needed for using it, will be done during the second session (T2). According to the guidelines, a fractional training is proposed 5 minutes, 3 times a day for 24 days (T2-T3).
Arm Title
Control group (no BFB training)
Arm Type
No Intervention
Arm Description
The participants assigned to the experimental group will not do a specific exercise during the intervention period (T2-T3).
Intervention Type
Behavioral
Intervention Name(s)
Heart rate variability Biofeedback [HRV-BFB]
Other Intervention Name(s)
Complementary technique
Intervention Description
BFB consists of a physiological recording used as a visual physiological feedback that can teach us how to control our physiology, which is naturally unconscious and uncontrollable. The BFB focused on the heart rate variability (HRV-BFB) could regulate the autonomic nervous system (vagal tone and sympathetic-parasympathetic balance) and the emotional state. The HRV BFB has received several clinical and experimental confirmations as a physiological remediation method. It is an innovative and non-pharmacological therapy frequently used to relieve stress.
Primary Outcome Measure Information:
Title
High frequency [HF] (0.15-0.40 Hz)
Description
High frequency (0.15-0.40 Hz), frequency-domain parameter HF will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Time Frame
Day 1 (T1)
Title
High frequency [HF] (0.15-0.40 Hz)
Description
High frequency (0.15-0.40 Hz), frequency-domain parameter HF will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Time Frame
Up to 25 days from T1 (T2)
Title
High frequency [HF] (0.15-0.40 Hz)
Description
High frequency (0.15-0.40 Hz), frequency-domain parameter HF will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Time Frame
Up to 52 days from T1 (T3)
Title
Root mean square of successive RR interval differences [RMSSD]
Description
Root mean square of successive RR interval differences, temporal-domain parameter RMSSD will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Time Frame
Day 1 (T1)
Title
Root mean square of successive RR interval differences [RMSSD]
Description
Root mean square of successive RR interval differences, temporal-domain parameter RMSSD will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Time Frame
Up to 25 days from T1 (T2)
Title
Root mean square of successive RR interval differences [RMSSD]
Description
Root mean square of successive RR interval differences, temporal-domain parameter RMSSD will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Time Frame
Up to 52 days from T1 (T3)
Secondary Outcome Measure Information:
Title
Low frequency [LF] (0.04-0.15 Hz)
Description
Low frequency (0.04-0.15 Hz), frequency-domain parameter LF will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Time Frame
Day 1 (T1)
Title
Low frequency [LF] (0.04-0.15 Hz)
Description
Low frequency (0.04-0.15 Hz), frequency-domain parameter LF will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Time Frame
Up to 25 days from T1 (T2)
Title
Low frequency [LF] (0.04-0.15 Hz)
Description
Low frequency (0.04-0.15 Hz), frequency-domain parameter LF will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Time Frame
Up to 52 days from T1 (T3)
Title
Low frequency [LF] 0.1 Hertz (0.075-0.108Hz)
Description
Spectral power of the low-frequency 0.1Hz band (0.075-0.108Hz), frequency-domain parameter LF-0.1Hz will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Time Frame
Day 1 (T1)
Title
Low frequency [LF] 0.1 Hertz (0.075-0.108Hz)
Description
Spectral power of the low-frequency 0.1Hz band (0.075-0.108Hz), frequency-domain parameter LF-0.1Hz will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Time Frame
Up to 25 days from T1 (T2)
Title
Low frequency [LF] 0.1 Hertz (0.075-0.108Hz)
Description
Spectral power of the low-frequency 0.1Hz band (0.075-0.108Hz), frequency-domain parameter LF-0.1Hz will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Time Frame
Up to 52 days from T1 (T3)
Title
Total power (0-0.40 Hz)
Description
Total power of the 0-0.40 Hertz band, frequency-domain parameter Total power will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Time Frame
Day 1 (T1)
Title
Total power (0-0.40 Hz)
Description
Total power of the 0-0.40 Hertz band, frequency-domain parameter Total power will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Time Frame
Up to 25 days from T1 (T2)
Title
Total power (0-0.40 Hz)
Description
Total power of the 0-0.40 Hertz band, frequency-domain parameter Total power will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Time Frame
Up to 52 days from T1 (T3)
Title
Ratio Low frequency / High frequency [LF / HF]
Description
Ratio of LF to HF power, frequency-domain parameter LF/HF will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Time Frame
Day 1 (T1)
Title
Ratio Low frequency / High frequency [LF / HF]
Description
Ratio of LF to HF power, frequency-domain parameter LF/HF will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Time Frame
Up to 25 days from T1 (T2)
Title
Ratio Low frequency / High frequency [LF / HF]
Description
Ratio of LF to HF power, frequency-domain parameter LF/HF will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Time Frame
Up to 52 days from T1 (T3)
Title
Standard deviation of all NN intervals [SDNN]
Description
Standard deviation of all NN intervals, temporal-domain parameter SDNN will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Time Frame
Day 1 (T1)
Title
Standard deviation of all NN intervals [SDNN]
Description
Standard deviation of all NN intervals, temporal-domain parameter SDNN will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Time Frame
Up to 25 days from T1 (T2)
Title
Standard deviation of all NN intervals [SDNN]
Description
Standard deviation of all NN intervals, temporal-domain parameter SDNN will be measured using the electrocardiogram [ECG]: ECG data will be recorded using 3 single use and adhesive electrodes placed on the inner side of the right wrist, on the right shoulder and on the left side in accordance with the DII standard position (Einthoven). Physiological data recorded are related to the heart rate variability [HRV].
Time Frame
Up to 52 days from T1 (T3)
Title
Skin conductance responses [SCR] frequency
Description
Skin conductance responses [SCR] frequency : number of the spontaneous galvanic skin responses by periods SCR will be measured using the Galvanic skin responses [GSR]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).
Time Frame
Day 1 (T1)
Title
Skin conductance responses [SCR] frequency
Description
Skin conductance responses [SCR] frequency : number of the spontaneous galvanic skin responses by periods SCR will be measured using the Galvanic skin responses [GSR]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).
Time Frame
Up to 25 days from T1 (T2)
Title
Skin conductance responses [SCR] frequency
Description
Skin conductance responses [SCR] frequency : number of the spontaneous galvanic skin responses by periods SCR will be measured using the Galvanic skin responses [GSR]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).
Time Frame
Up to 52 days from T1 (T3)
Title
Skin conductance responses [SCR] amplitude
Description
Skin conductance responses amplitude: amplitude of the spontaneous galvanic skin responses by periods SCR will be measured using the Galvanic skin responses [GSR]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).
Time Frame
Day 1 (T1)
Title
Skin conductance responses [SCR] amplitude
Description
Skin conductance responses amplitude: amplitude of the spontaneous galvanic skin responses by periods SCR will be measured using the Galvanic skin responses [GSR]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).
Time Frame
Up to 25 days from T1 (T2)
Title
Skin conductance responses [SCR] amplitude
Description
Skin conductance responses amplitude: amplitude of the spontaneous galvanic skin responses by periods SCR will be measured using the Galvanic skin responses [GSR]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).
Time Frame
Up to 52 days from T1 (T3)
Title
Integrated skin conductance responses [ISCR]
Description
Integrated skin conductance responses [ISCR]: area of the galvanic skin responses identified on the signal ISCR will be measured using the Galvanic skin responses [GSR]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).
Time Frame
Day 1 (T1)
Title
Integrated skin conductance responses [ISCR]
Description
Integrated skin conductance responses [ISCR]: area of the galvanic skin responses identified on the signal ISCR will be measured using the Galvanic skin responses [GSR]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).
Time Frame
Up to 25 days from T1 (T2)
Title
Integrated skin conductance responses [ISCR]
Description
Integrated skin conductance responses [ISCR]: area of the galvanic skin responses identified on the signal ISCR will be measured using the Galvanic skin responses [GSR]: GSR data will be recorded using 2 skin sensors placed on the third phalanx of the forefinger and of the middle finger of the left hand. Physiological data recorded are related to the cholinergic sympathetic activity (tonic GSR / phasic GSR).
Time Frame
Up to 52 days from T1 (T3)
Title
Pulsatility index variation [PI]
Description
Pulsatility index variation [PI] : transit time flow PI will be measured using the Photoplethysmography [PPG]: PPG data will be recorded using a finger sensor. Physiological data recorded are related to the adrenergic sympathetic tone and allowing a record of the blood pulse waves associated with the heart rate.
Time Frame
Day 1 (T1)
Title
Pulsatility index variation [PI]
Description
Pulsatility index variation [PI] : transit time flow PI will be measured using the Photoplethysmography [PPG]: PPG data will be recorded using a finger sensor. Physiological data recorded are related to the adrenergic sympathetic tone and allowing a record of the blood pulse waves associated with the heart rate.
Time Frame
Up to 25 days from T1 (T2)
Title
Pulsatility index variation [PI]
Description
Pulsatility index variation [PI] : transit time flow PI will be measured using the Photoplethysmography [PPG]: PPG data will be recorded using a finger sensor. Physiological data recorded are related to the adrenergic sympathetic tone and allowing a record of the blood pulse waves associated with the heart rate.
Time Frame
Up to 52 days from T1 (T3)
Title
Breathing rate
Description
Breathing rate by cycles per minute The breathing rate will be measured using a breathing belt.
Time Frame
Day 1 (T1)
Title
Breathing rate
Description
Breathing rate by cycles per minute The breathing rate will be measured using a breathing belt.
Time Frame
Up to 25 days from T1 (T2)
Title
Breathing rate
Description
Breathing rate by cycles per minute The breathing rate will be measured using a breathing belt.
Time Frame
Up to 52 days from T1 (T3)
Title
Dominant power (0-0.15Hz)
Description
Dominant power of the 0-0.15 Hertz band, frequency-domain parameter Dominant power will be measured using the electrogastrogram [EGG]: EGG data will be recorded using 6 single use and adhesive electrodes placed on the skin of the abdomen.
Time Frame
Day 1 (T1)
Title
Dominant power (0-0.15Hz)
Description
Dominant power of the 0-0.15 Hertz band, frequency-domain parameter Dominant power will be measured using the electrogastrogram [EGG]: EGG data will be recorded using 6 single use and adhesive electrodes placed on the skin of the abdomen.
Time Frame
Up to 25 days from T1 (T2)
Title
Dominant power (0-0.15Hz)
Description
Dominant power of the 0-0.15 Hertz band, frequency-domain parameter Dominant power will be measured using the electrogastrogram [EGG]: EGG data will be recorded using 6 single use and adhesive electrodes placed on the skin of the abdomen.
Time Frame
Up to 52 days from T1 (T3)
Title
Total power (0-0.15Hz)
Description
Total power of the 0-0.15 Hertz band, frequency-domain parameter Total power will be measured using the electrogastrogram [EGG]: EGG data will be recorded using 6 single use and adhesive electrodes placed on the skin of the abdomen.
Time Frame
Day 1 (T1)
Title
Total power (0-0.15Hz)
Description
Total power of the 0-0.15 Hertz band, frequency-domain parameter Total power will be measured using the electrogastrogram [EGG]: EGG data will be recorded using 6 single use and adhesive electrodes placed on the skin of the abdomen.
Time Frame
Up to 25 days from T1 (T2)
Title
Total power (0-0.15Hz)
Description
Total power of the 0-0.15 Hertz band, frequency-domain parameter Total power will be measured using the electrogastrogram [EGG]: EGG data will be recorded using 6 single use and adhesive electrodes placed on the skin of the abdomen.
Time Frame
Up to 52 days from T1 (T3)
Title
Slow-waves frequency (physiological outcome)
Description
Slow-waves frequency per minute, frequency-domain parameter Slow-wave frequency will be measured using the electrogastrogram [EGG]: EGG data will be recorded using 6 single use and adhesive electrodes placed on the skin of the abdomen.
Time Frame
Day 1 (T1)
Title
Slow-waves frequency (physiological outcome)
Description
Slow-waves frequency per minute, frequency-domain parameter Slow-wave frequency will be measured using the electrogastrogram [EGG]: EGG data will be recorded using 6 single use and adhesive electrodes placed on the skin of the abdomen.
Time Frame
Up to 25 days from T1 (T2)
Title
Slow-waves frequency (physiological outcome)
Description
Slow-waves frequency per minute, frequency-domain parameter Slow-wave frequency will be measured using the electrogastrogram [EGG]: EGG data will be recorded using 6 single use and adhesive electrodes placed on the skin of the abdomen.
Time Frame
Up to 52 days from T1 (T3)
Title
Delta frequency (0-4Hz)
Description
Delta frequency 0-4 Hertz band Delta frequency will be measured using the electroencephalogram [EEG]: EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Time Frame
Day 1 (T1)
Title
Delta frequency (0-4Hz)
Description
Delta frequency 0-4 Hertz band Delta frequency will be measured using the electroencephalogram [EEG]: EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Time Frame
Up to 25 days from T1 (T2)
Title
Delta frequency (0-4Hz)
Description
Delta frequency 0-4 Hertz band Delta frequency will be measured using the electroencephalogram [EEG]: EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Time Frame
Up to 52 days from T1 (T3)
Title
Theta frequency (4-7Hz)
Description
Theta frequency 4-7 Hertz band Theta frequency will be measured using the electroencephalogram [EEG]: EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Time Frame
Day 1 (T1)
Title
Theta frequency (4-7Hz)
Description
Theta frequency 4-7 Hertz band Theta frequency will be measured using the electroencephalogram [EEG]: EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Time Frame
Up to 25 days from T1 (T2)
Title
Theta frequency (4-7Hz)
Description
Theta frequency 4-7 Hertz band Theta frequency will be measured using the electroencephalogram [EEG]: EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Time Frame
Up to 52 days from T1 (T3)
Title
Alpha frequency (8-12Hz)
Description
Alpha frequency 8-12 Hertz band Alpha frequency will be measured using the electroencephalogram [EEG]: EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Time Frame
Day 1 (T1)
Title
Alpha frequency (8-12Hz)
Description
Alpha frequency 8-12 Hertz band Alpha frequency will be measured using the electroencephalogram [EEG]: EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Time Frame
Up to 25 days from T1 (T2)
Title
Alpha frequency (8-12Hz)
Description
Alpha frequency 8-12 Hertz band Alpha frequency will be measured using the electroencephalogram [EEG]: EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Time Frame
Up to 52 days from T1 (T3)
Title
Beta frequency (13-30Hz)
Description
Beta frequency 13-30 Hertz band Beta frequency will be measured using the electroencephalogram [EEG]: EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Time Frame
Day 1 (T1)
Title
Beta frequency (13-30Hz)
Description
Beta frequency 13-30 Hertz band Beta frequency will be measured using the electroencephalogram [EEG]: EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Time Frame
Up to 25 days from T1 (T2)
Title
Beta frequency (13-30Hz)
Description
Beta frequency 13-30 Hertz band Beta frequency will be measured using the electroencephalogram [EEG]: EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Time Frame
Up to 52 days from T1 (T3)
Title
Gamma frequency (>30Hz)
Description
Gamma frequency >30 Hertz band Gamma frequency will be measured using the electroencephalogram [EEG]: EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Time Frame
Day 1 (T1)
Title
Gamma frequency (>30Hz)
Description
Gamma frequency >30 Hertz band Gamma frequency will be measured using the electroencephalogram [EEG]: EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Time Frame
Up to 25 days from T1 (T2)
Title
Gamma frequency (>30Hz)
Description
Gamma frequency >30 Hertz band Gamma frequency will be measured using the electroencephalogram [EEG]: EEG data will be recorded using a EEG headsets including 64 electrodes. The EEG is related to the brain activity generated by the neural functioning.
Time Frame
Up to 52 days from T1 (T3)
Title
Alexithymia score
Description
Alexithymia score will be measured using the Bermond-Vorst Alexithymia Questionnaire B version (BVAQ-B; Vorst & Bermond, 2001; French version Deborde et al., 2004). The subscale as considered as a trait scale including 20 items.
Time Frame
Up to 16 days from T2
Title
Neuroticism score
Description
Neuroticism score will be measured using the Big Five Inventory-Neuroticism (BFI-N; John et al., 1991; French version Plaisant et al., 2005). The subscale as considered as a trait scale including 8 items.
Time Frame
Up to 16 days from T1
Title
Trait and state anxiety scores
Description
The trai and state anxiety scores will be measured using the State-Trait Anxiety Inventory (STAI Y-AB) (Spielberger et al., 1983; French version Bruchon-Schweitzer & Paulhan, 1990). The scale includes 40 items.
Time Frame
Up to 8 days from T1
Title
Style of coping
Description
The style of coping will be measured using the Brief Cope (Carver, 1997; French version Muller & Spitz, 2003). We will use it in its trait version. The subscale as considered as a trait scale including 28 items.
Time Frame
Up to 16 days from T1
Title
Positive affectivity score
Description
Positive affectivity score will be measured using the Positive And Negative Affect Schedule (PANAS; Watson et al., 1988; French version Caci & Bayle, 2007). To measure a global affective state, a score of positivity will be calculated by subtracting negative affect score from positive affect score. The subscale as considered as a state scale including 20 items.
Time Frame
Day 1 (T1)
Title
Positive affectivity score
Description
Positive affectivity score will be measured using the Positive And Negative Affect Schedule (PANAS; Watson et al., 1988; French version Caci & Bayle, 2007). To measure a global affective state, a score of positivity will be calculated by subtracting negative affect score from positive affect score. The subscale as considered as a state scale including 20 items.
Time Frame
Up to 25 days from T1 (T2)
Title
Positive affectivity score
Description
Positive affectivity score will be measured using the Positive And Negative Affect Schedule (PANAS; Watson et al., 1988; French version Caci & Bayle, 2007). To measure a global affective state, a score of positivity will be calculated by subtracting negative affect score from positive affect score. The subscale as considered as a state scale including 20 items.
Time Frame
Up to 52 days from T1 (T3)
Title
Depressive symptoms score
Description
The depressive symptoms score will be measured using the Center for Epidemiologic Studies-Depression Scale (CES-D; Radloff, 1977; French version Führer & Rouillon, 1989). The subscale as considered as a state scale including 20 items.
Time Frame
Day 1 (T1)
Title
Depressive symptoms score
Description
The depressive symptoms score will be measured using the Center for Epidemiologic Studies-Depression Scale (CES-D; Radloff, 1977; French version Führer & Rouillon, 1989). The subscale as considered as a state scale including 20 items.
Time Frame
Up to 25 days from T1 (T2)
Title
Depressive symptoms score
Description
The depressive symptoms score will be measured using the Center for Epidemiologic Studies-Depression Scale (CES-D; Radloff, 1977; French version Führer & Rouillon, 1989). The subscale as considered as a state scale including 20 items.
Time Frame
Up to 52 days from T1 (T3)
Title
Perceived-stress level
Description
The perceived-stress level will be measured using the Perceived Stress Scale (PSS; Cohen et al., 1983; French version Bellighausen et al., 2009). The subscale as considered as a state scale including 10 items.
Time Frame
Day 1 (T1)
Title
Perceived-stress level
Description
The perceived-stress level will be measured using the Perceived Stress Scale (PSS; Cohen et al., 1983; French version Bellighausen et al., 2009). The subscale as considered as a state scale including 10 items.
Time Frame
Up to 25 days from T1 (T2)
Title
Perceived-stress level
Description
The perceived-stress level will be measured using the Perceived Stress Scale (PSS; Cohen et al., 1983; French version Bellighausen et al., 2009). The subscale as considered as a state scale including 10 items.
Time Frame
Up to 52 days from T1 (T3)
Title
Coping flexibility
Description
The coping flexibility score will be measured using the Coping Flexibility Scale (CFS; Kato, 2012). The CFS measures the coping flexibility including 10 items. The subscale as considered as a state scale.
Time Frame
Day 1 (T1)
Title
Coping flexibility
Description
The coping flexibility score will be measured using the Coping Flexibility Scale (CFS; Kato, 2012). The CFS measures the coping flexibility including 10 items. The subscale as considered as a state scale.
Time Frame
Up to 25 days from T1 (T2)
Title
Coping flexibility
Description
The coping flexibility score will be measured using the Coping Flexibility Scale (CFS; Kato, 2012). The CFS measures the coping flexibility including 10 items. The subscale as considered as a state scale.
Time Frame
Up to 52 days from T1 (T3)
Title
Metacoping
Description
The metacoping score will be measured using a visual analogue scale (VAS). The VAS was developed by ourselves to measure the perceived effectiveness of coping by asking: " how strategies used by yourself to cope with the situation were efficient? ". The participants will have to rate from 0 (no efficacy) to 10 (maximum of efficacy). The subscale as considered as a state scale.
Time Frame
Day 1 (T1)
Title
Metacoping
Description
The metacoping score will be measured using a visual analogue scale (VAS). The VAS was developed by ourselves to measure the perceived effectiveness of coping by asking: " how strategies used by yourself to cope with the situation were efficient? ". The participants will have to rate from 0 (no efficacy) to 10 (maximum of efficacy). The subscale as considered as a state scale.
Time Frame
Up to 25 days from T1 (T2)
Title
Metacoping
Description
The metacoping score will be measured using a visual analogue scale (VAS). The VAS was developed by ourselves to measure the perceived effectiveness of coping by asking: " how strategies used by yourself to cope with the situation were efficient? ". The participants will have to rate from 0 (no efficacy) to 10 (maximum of efficacy). The subscale as considered as a state scale.
Time Frame
Up to 52 days from T1 (T3)
Title
Social support score
Description
The social support score will be measured using the Social Support Questionnaire short version (SSQ6; Sarason et al., 1987a; French version Bruchon-Schweitzer et al., 2003). The subscale as considered as a trait scale including 6 items.
Time Frame
Up to 8 days from T1
Title
Interceptive sensitivity score
Description
The interceptive sensitivity score will be measured using the Multidimensional Assessment of Interoceptive Awareness second version (MAIA-2; Mehling et al., 2018). The subscale as considered as a trait scale including 37 items.
Time Frame
Up to 8 days from T1
Title
Life satisfaction score
Description
The life satisfaction score will be measured using the Satisfaction With Life Scale (SWLS; Diener et al., 1985; French version Blais et al., 1989). The subscale as considered as a state scale including 5 items.
Time Frame
Day 1 (T1)
Title
Life satisfaction score
Description
The life satisfaction score will be measured using the Satisfaction With Life Scale (SWLS; Diener et al., 1985; French version Blais et al., 1989). The subscale as considered as a state scale including 5 items.
Time Frame
Up to 25 days from T1 (T2)
Title
Life satisfaction score
Description
The life satisfaction score will be measured using the Satisfaction With Life Scale (SWLS; Diener et al., 1985; French version Blais et al., 1989). The subscale as considered as a state scale including 5 items.
Time Frame
Up to 52 days from T1 (T3)
Title
Negative impact scores
Description
The negative impact score will be measured using the Life Experiences Survey (LES; Sarason et al., 1978). The subscale as considered as a trait scale including 50 items. In this study a modified version of the LES will be used, whereby subjects documented the presence and perceived impact of adulthood life events that had occurred since 18 years of age to the time of completion of the survey. For the purposes of this study, 3 scores will be generated from this survey: the number of negatively perceived life events, the negative impact score determined by the sum of the impact scores of negatively perceived life events alone (higher scores indicate greater negative impact), and the total impact score determined by the sum of the impact scores of both negatively and positively perceived life events (higher scores indicate an overall more positive impact and lower scores indicate an overall more negative impact of all adulthood life events).
Time Frame
Up to 16 days from T2
Title
Frequency, severity and intensity scores
Description
The frequency, severity and intensity scores will be measured using the Daily Hassles Scale (DHS; Kanner et al., 1981). The subscale as considered as a trait scale including 117 items.
Time Frame
Up to 8 days from T2
Title
Child Abuse scores
Description
The child abuse scores will be measured using the Childhood Trauma Questionnaire-Short Form (CTQ; Bernstein et al., 2003). The subscale as considered as a trait scale including 28 items.
Time Frame
Up to 16 days from T1
Title
Acceptance score
Description
The acceptance score will be measured using the Illness Cognition Questionnaire for chronic disease (ICQ-18; Evers et al., 2001). The subscale as considered as a state scale including 18 items.
Time Frame
Day 1 (T1)
Title
Acceptance score
Description
The acceptance score will be measured using the Illness Cognition Questionnaire for chronic disease (ICQ-18; Evers et al., 2001). The subscale as considered as a state scale including 18 items.
Time Frame
Up to 25 days from T1 (T2)
Title
Acceptance score
Description
The acceptance score will be measured using the Illness Cognition Questionnaire for chronic disease (ICQ-18; Evers et al., 2001). The subscale as considered as a state scale including 18 items.
Time Frame
Up to 52 days from T1 (T3)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Somatoform disorders (IBS or PNES) diagnosis must be established by the partner doctors Participants must have home computer Participants must be of the age of majority Participants must be registered for social security Participants must have signed an informed consent Exclusion Criteria: Specially protected participants (under clauses L1121-5 and L1121-8 by the code of public health): juveniles, pregnant womens, nursing mothers, law's protection peoples Participants suffering from a severe psychiatric disease needing specialised attention Participants suffering from or have suffered from a severe disease causing autonomic dysfunctions (heart failure, asthma, blood disease, renal failure, peripheral neuropathy, vagotomy, thyroid disorder, alcoholism, liver disease, amyloidosis) Participants taking medication which could be impact autonomic nervous system activity (anticholinergic, antiarrhythmics, clonidine, beta-blockers, tricyclic anti-depressants, metronidazole) Participants placing under judicial or administrative supervisions Participants were compensated more than 4500 euros because of his research protocol participation concerning human over the 12 months prior to the actual study Participants being not be able to contact in emergency Participants being in an exclusion period from another study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Séphora MINJOZ, PhD student
Phone
(+33)635178670
Email
sepho.minjoz@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sonia PELLISSIER, Dr
Phone
(+33)479759133
Email
sonia.pellissier@univ-smb.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno BONAZ, Pr
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, Grenoble Alpes
City
Grenoble
State/Province
Isère
ZIP/Postal Code
38700
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Séphora Minjoz, PhD student
Phone
(+33)635178670
Email
sepho.minjoz@gmail.com
First Name & Middle Initial & Last Name & Degree
Sonia Pellissier, Dr
Phone
(+33)479759133
Email
sonia.pellissier@univ-smb.fr
First Name & Middle Initial & Last Name & Degree
Bruno Bonaz, Pr
First Name & Middle Initial & Last Name & Degree
Laurent Vercueil, Dr
First Name & Middle Initial & Last Name & Degree
Cécile Sabourdy, Dr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
8598068
Citation
Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.
Results Reference
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PubMed Identifier
28265249
Citation
Laborde S, Mosley E, Thayer JF. Heart Rate Variability and Cardiac Vagal Tone in Psychophysiological Research - Recommendations for Experiment Planning, Data Analysis, and Data Reporting. Front Psychol. 2017 Feb 20;8:213. doi: 10.3389/fpsyg.2017.00213. eCollection 2017.
Results Reference
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PubMed Identifier
15029085
Citation
Muller L, Spitz E. [Multidimensional assessment of coping: validation of the Brief COPE among French population]. Encephale. 2003 Nov-Dec;29(6):507-18. French.
Results Reference
background
PubMed Identifier
30513087
Citation
Mehling WE, Acree M, Stewart A, Silas J, Jones A. The Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2). PLoS One. 2018 Dec 4;13(12):e0208034. doi: 10.1371/journal.pone.0208034. eCollection 2018.
Results Reference
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PubMed Identifier
32235865
Citation
Varon C, Morales J, Lazaro J, Orini M, Deviaene M, Kontaxis S, Testelmans D, Buyse B, Borzee P, Sornmo L, Laguna P, Gil E, Bailon R. A Comparative Study of ECG-derived Respiration in Ambulatory Monitoring using the Single-lead ECG. Sci Rep. 2020 Mar 31;10(1):5704. doi: 10.1038/s41598-020-62624-5.
Results Reference
background
PubMed Identifier
29740350
Citation
de Vroege L, Emons WHM, Sijtsma K, van der Feltz-Cornelis CM. Psychometric Properties of the Bermond-Vorst Alexithymia Questionnaire (BVAQ) in the General Population and a Clinical Population. Front Psychiatry. 2018 Apr 23;9:111. doi: 10.3389/fpsyt.2018.00111. eCollection 2018.
Results Reference
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PubMed Identifier
29787784
Citation
Bulut NS, Wurz A, Yorguner Kupeli N, Carkaxhiu Bulut G, Sungur MZ. Heart rate variability response to affective pictures processed in and outside of conscious awareness: Three consecutive studies on emotional regulation. Int J Psychophysiol. 2018 Jul;129:18-30. doi: 10.1016/j.ijpsycho.2018.05.006. Epub 2018 May 19.
Results Reference
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PubMed Identifier
31071705
Citation
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Results Reference
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PubMed Identifier
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Citation
Sarason IG, Johnson JH, Siegel JM. Assessing the impact of life changes: development of the Life Experiences Survey. J Consult Clin Psychol. 1978 Oct;46(5):932-46. doi: 10.1037//0022-006x.46.5.932. No abstract available.
Results Reference
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PubMed Identifier
3397865
Citation
Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
Results Reference
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URL
https://doi.org/10.1016/S0191-8869(00)00033-7
Description
Vorst, Harrie C.M, et Bob Bermond. " Validity and Reliability of the Bermond-Vorst Alexithymia Questionnaire ". Personality and Individual Differences 30, no 3 (février 2001): 413 34.
URL
https://doi.org/10.1016/j.amp.2005.02.002
Description
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URL
https://hdl.handle.net/11299/98561
Description
Radloff LS. The CES-D scale: a self report depression scalefor research in the general population. App Psycho Meas1977;1:384-401.

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Neurovegetative Decoupling in Somatoform Disorders : Biofeedback Interest

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