Back to resultsEvaluation of the Efficacy of a Single Brief Intervention of Mindfulness to Reduce Stress Response in a Social Stress Task Paradigm (SBST_FMS)
Primary Purpose
Mindfulness, Fibromyalgia, Stress
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Mindfulness
Psycho-education
Sponsored by
About this trial
This is an interventional treatment trial for Mindfulness
Eligibility Criteria
Inclusion Criteria:
- We plan to recruit adult female patients (>18 years old) suffering from fibromyalgia (FMS), with chronic pain (more than 6 months), willing and able to give informed consent. Specifically, patients must fulfil the criteria of the American College of Rheumatology (2010) by having the following combination of scores at the widespread pain index (WPI) and the severity score (SS) :
- WPI score is ≥7 and the SS score is ≥ 5 OR
- WPI score is comprised between 3 to 6 and the SS score ≥9
- And no other condition explaining the painful syndrome
Exclusion Criteria:
- Insufficient French language skills
- Unstable psychiatric co-morbidity: major depression with current suicidal risk, unstable psychotic disorder, unstable psychotropic medication (stable=more than 3 month under the same dose).
- Somatic co-morbidity that could interfere with physiological monitoring/stress tolerance: such as cardiac malformation, recent myocardial dysfunction, cardiac transplantation, or cardiac treatment (pacemaker, antiarrhythmic drugs, muscarinic receptor blockers, ACE inhibitors or any that would induce a modification in HR)
- Contraindication to sensors positioning (local skin damage or allergies)
- Substance use disorder (alcohol, drugs).
- Refusal to listen to an audio recording of mindfulness
Sites / Locations
- Centre de Médecine Intégrative et Complémentaire, CHUVRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mindfulness
Psycho-education
Arm Description
Outcomes
Primary Outcome Measures
Perceived stress reactivity
The primary outcome is the variation of perceived stress level along the task. A 2-way repeated-measures ANOVA will be conducted to compare the stress reactivity of patients receiving the mindfulness intervention and the control intervention.
Perceived stress will be measured using visual analog scales from 0 to 10, 0 meaning no stress perceived and 10 meaning the highest stress perceived.
Secondary Outcome Measures
Heart rate variability
Heart rate variability will also be measured using a NeXus-10 MKII, Mindmedia with 3 electrodes.
A 2-way repeated-measures ANOVA will be conducted to compare the heart rate variability of patients receiving the mindfulness intervention and the control intervention.
Respiration rate
Respiration rate will also be measured using a NeXus-10 MKII, Mindmedia with a thoracic belt.
A 2-way repeated-measures ANOVA will be conducted to compare the respiration rate of patients receiving the mindfulness intervention and the control intervention.
Oxygen saturation
Oxygen saturation will also be measured using a NeXus-10 MKII, Mindmedia with a pulse oximeter probe.
A 2-way repeated-measures ANOVA will be conducted to compare the oxygen saturation of patients receiving the mindfulness intervention and the control intervention.
Electrodermal activity
Electrodermal activity will also be measured using a NeXus-10 MKII, Mindmedia with two fingertips electrodes.
A 2-way repeated-measures ANOVA will be conducted to compare the electrodermal activity of patients receiving the mindfulness intervention and the control intervention.
Cerebral activity
Cerebral activity will also be measured using a 6-electrodes headband electroencephalogram (Dreem headband, Dreem SAS).
Salivary cortisol concentrations
Salivary cortisol concentration will also be collected using a mouth cotton swab. A 2-way repeated-measures ANOVA will be conducted to compare the salivary cortisol concentrations of patients receiving the mindfulness intervention and the control intervention.
Blood catecholamine levels
Blood catecholamine levels will also be collected using a venous line on the non-dominant arm for repeated blood collection. A 2-way repeated-measures ANOVA will be conducted to compare the blood catecholamine levels of patients receiving the mindfulness intervention and the control intervention.
Full Information
NCT ID
NCT05568030
First Posted
September 1, 2022
Last Updated
January 26, 2023
Sponsor
University of Lausanne Hospitals
1. Study Identification
Unique Protocol Identification Number
NCT05568030
Brief Title
Evaluation of the Efficacy of a Single Brief Intervention of Mindfulness to Reduce Stress Response in a Social Stress Task Paradigm
Acronym
SBST_FMS
Official Title
Evaluation of the Efficacy of a Single Brief Intervention of Mindfulness to Reduce Stress Response in a Social Stress Task Paradigm
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 28, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lausanne Hospitals
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
This study is a double-blinded randomized controlled trial with two arms, comparing a recorded mindfulness intervention to a control psycho-education audio. It is a monocentric study that will take place in Centre Hospitalier Universitaire Vaudois (CHUV), a primary teaching hospital in Lausanne, Switzerland.
Patients will be randomized 1:1 to the brief mindfulness intervention vs neutral audio intervention. The investigators involved in recruitment and testing will be blind to the intervention condition. A collaborator that is not involved in this study will prepare a coded randomized sequence of audio assignments, uploaded in Redcap. The audio will be played on a laptop or mp-player with a noise cancelling headset.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mindfulness, Fibromyalgia, Stress
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness
Arm Type
Experimental
Arm Title
Psycho-education
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness
Intervention Description
One session of a 20 minute mindfulness recording, based on standardised script, focused on stress management.
Intervention Type
Behavioral
Intervention Name(s)
Psycho-education
Intervention Description
One session of a 20 minute recording, based on standardised script, focused on psychophysiological stress response description.
Primary Outcome Measure Information:
Title
Perceived stress reactivity
Description
The primary outcome is the variation of perceived stress level along the task. A 2-way repeated-measures ANOVA will be conducted to compare the stress reactivity of patients receiving the mindfulness intervention and the control intervention.
Perceived stress will be measured using visual analog scales from 0 to 10, 0 meaning no stress perceived and 10 meaning the highest stress perceived.
Time Frame
Within 3 hours
Secondary Outcome Measure Information:
Title
Heart rate variability
Description
Heart rate variability will also be measured using a NeXus-10 MKII, Mindmedia with 3 electrodes.
A 2-way repeated-measures ANOVA will be conducted to compare the heart rate variability of patients receiving the mindfulness intervention and the control intervention.
Time Frame
Within 3 hours
Title
Respiration rate
Description
Respiration rate will also be measured using a NeXus-10 MKII, Mindmedia with a thoracic belt.
A 2-way repeated-measures ANOVA will be conducted to compare the respiration rate of patients receiving the mindfulness intervention and the control intervention.
Time Frame
Within 3 hours
Title
Oxygen saturation
Description
Oxygen saturation will also be measured using a NeXus-10 MKII, Mindmedia with a pulse oximeter probe.
A 2-way repeated-measures ANOVA will be conducted to compare the oxygen saturation of patients receiving the mindfulness intervention and the control intervention.
Time Frame
Within 3 hours
Title
Electrodermal activity
Description
Electrodermal activity will also be measured using a NeXus-10 MKII, Mindmedia with two fingertips electrodes.
A 2-way repeated-measures ANOVA will be conducted to compare the electrodermal activity of patients receiving the mindfulness intervention and the control intervention.
Time Frame
Within 3 hours
Title
Cerebral activity
Description
Cerebral activity will also be measured using a 6-electrodes headband electroencephalogram (Dreem headband, Dreem SAS).
Time Frame
Within 3 hours
Title
Salivary cortisol concentrations
Description
Salivary cortisol concentration will also be collected using a mouth cotton swab. A 2-way repeated-measures ANOVA will be conducted to compare the salivary cortisol concentrations of patients receiving the mindfulness intervention and the control intervention.
Time Frame
Within 3 hours
Title
Blood catecholamine levels
Description
Blood catecholamine levels will also be collected using a venous line on the non-dominant arm for repeated blood collection. A 2-way repeated-measures ANOVA will be conducted to compare the blood catecholamine levels of patients receiving the mindfulness intervention and the control intervention.
Time Frame
Within 3 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
We plan to recruit adult female patients (>18 years old) suffering from fibromyalgia (FMS), with chronic pain (more than 6 months), willing and able to give informed consent. Specifically, patients must fulfil the criteria of the American College of Rheumatology (2010) by having the following combination of scores at the widespread pain index (WPI) and the severity score (SS) :
WPI score is ≥7 and the SS score is ≥ 5 OR
WPI score is comprised between 3 to 6 and the SS score ≥9
And no other condition explaining the painful syndrome
Exclusion Criteria:
Insufficient French language skills
Unstable psychiatric co-morbidity: major depression with current suicidal risk, unstable psychotic disorder, unstable psychotropic medication (stable=more than 3 month under the same dose).
Somatic co-morbidity that could interfere with physiological monitoring/stress tolerance: such as cardiac malformation, recent myocardial dysfunction, cardiac transplantation, or cardiac treatment (pacemaker, antiarrhythmic drugs, muscarinic receptor blockers, ACE inhibitors or any that would induce a modification in HR)
Contraindication to sensors positioning (local skin damage or allergies)
Substance use disorder (alcohol, drugs).
Refusal to listen to an audio recording of mindfulness
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chantal Berna, Prof
Phone
+41213142040
Email
chantal.berna-renella@chuv.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chantal Berna, Prof
Organizational Affiliation
Centre de médecine intégrative et complémentaire, CHUV
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de Médecine Intégrative et Complémentaire, CHUV
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chantal Berna, Prof
Phone
+41213142040
Email
chantal.berna-renella@chuv.ch
First Name & Middle Initial & Last Name & Degree
Chantal Berna, Prof
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Efficacy of a Single Brief Intervention of Mindfulness to Reduce Stress Response in a Social Stress Task Paradigm
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