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Augmentation of EMDR With MtCS in the Treatment of Fibromyalgia

Primary Purpose

Fibromyalgia, Psychological Trauma, Depressive Symptoms

Status
Suspended
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Eye Movement Desensitization and Reprocessing therapy
Multifocal transcranial Current Stimulation
Sponsored by
Parc de Salut Mar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Psychological trauma, Posttraumatic stress disorder, Major depressive disorder, Anxiety disorder, Eye Movement Desensitization and Reprocessing, Multifocal transcranial Current Stimulation

Eligibility Criteria

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

Inclusion Criteria:

  • Age between 18 and 70 years old
  • Mean pain score of at least 4 on the visual analog scale (VAS) in the two weeks preceding the clinical trial
  • Presence of one or more traumatic events causing current trauma-related symptoms
  • Current clinical symptoms of depression and/or anxiety
  • 2 weeks of stable medication

Exclusion Criteria:

  • Comorbid autoimmune or chronic inflammatory disease
  • Neurological or serious medical diseases
  • Bipolar disorder, schizoaffective disorder and schizophrenia
  • Suicidal ideation
  • Previous EMDR therapy
  • Substance abuse/dependency within 1 month prior to participation (except for nicotine abuse/dependency),
  • Pending FM-related litigation or disability
  • Metallic implants in the head
  • Positive test for pregnancy

Sites / Locations

  • Centre Forum (Parc de Salut Mar)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

No Intervention

Arm Label

EMDR plus MtCS

EMDR plus sham-MtCS

Treatment as Usual

Arm Description

MtCS stimulation will consist of 1mA MtDCS for 20 minutes applied immediately before EMDR sessions.

Sham stimulation will consist of inactive MtDCS for 20 minutes applied immediately before EMDR sessions

Patients in this condition will not receive EMDR nor MtCS sessions, and will continue to attend their regular visits with rheumatology and psychiatry. The patients from the TAU group will have the choice to attend 10 sessions of EMDR group therapy when the research project finishes.

Outcomes

Primary Outcome Measures

Change in pain assessed with the Visual Analogic Scale Questionnaire.
Severity and changes in pain intensity will be assessed with the Visual Analogic Scale (rated in a continuum from 0 to 10).
Change in pain assessed with the Pain Dissability Index.
Severity and changes in pain intensity will be assessed with the Pain Disability Index (7 items rated from 0 to 10, making a total score from 0 to 70).
Change in pain assessed with the Fibromyalgia Impact Questionnaire.
Severity and changes in pain intensity will be assessed with the Fibromyalgia Impact Questionnaire (the first items is rated from 0 to 4, the second from 0 to 7 and the third from 0 to 5; whereas the other 7 items are rated from 0 to 10, with a cut-off score of 50).
Change in depressive symptoms assessed by with the Hospital Anxiety and Depression Scale
Severity and changes in depressive symptoms will be evaluated with the Hospital Anxiety and Depression Scale. Items are rated on a 4-point Likert scale from 0 and 3, yielding a total score ranging from 0 to 21 and a cut-off score of 8 indicating probable clinical symptoms.
Change in anxious symptoms evaluated with the Hospital Anxiety and Depression Scale.
Severity and changes in anxious symptoms will be evaluated with the Hospital Anxiety and Depression Scale. Items are rated on a 4-point Likert scale from 0 and 3, yielding a total score ranging from 0 to 21 and a cut-off score of 8 indicating probable clinical symptoms.
Change in trauma associated symptoms assessed with the Impact of Events Scale-Revised.
Psychological trauma will be evaluated using the Impact of Events Scale-Revised. This scale consists in 22-item to determine frequency and impact of posttraumatic symptoms experienced, with subscales of intrusion, avoidance and hyperarousal, each scored on a 5-point Likert scale, yielding a score for each subscale and a total score. This scale has a scoring range of 0 to 88. On this test, scores that exceed 24 can be quite meaningful. High scores have the following associations: 24 or more PTSD is a clinical concern. Those with scores this high who do not have full PTSD will have partial PTSD or at least some of the symptoms; 33 and above represents the best cutoff for a probable diagnosis of PTSD; 37 or more this is high enough to suppress your immune system's functioning (even 10 years after an impact event).

Secondary Outcome Measures

Change in subjective wellbeing measured with the Satisfaction With Life Scale.
The improvement of subjective wellbeing will be evaluated using the Satisfaction With Life Scale. This scale is completed by 5 items rated from 1 (totally agree) to 5 (totally disagree), with a maximum score of 25.
Change in insomnia symptoms assessed with the Athens Insomnia Scale.
The improvement of insomnia symptoms will be evaluated using the Athens Insomnia Scale. This scale is completed by 8 items rated from 0 to 3, with a maximum score of 24.

Full Information

First Posted
August 2, 2019
Last Updated
December 1, 2022
Sponsor
Parc de Salut Mar
Collaborators
Universitat Oberta de Catalunya, Institut d'Investigacions Biomèdiques August Pi i Sunyer
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1. Study Identification

Unique Protocol Identification Number
NCT04084795
Brief Title
Augmentation of EMDR With MtCS in the Treatment of Fibromyalgia
Official Title
Augmentation of EMDR With Multifocal Transcranial Current Stimulation in the Treatment of Fibromyalgia: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Suspended
Why Stopped
To the impossibility to visit patients at the hospital by COVID-19.When the situation stabilizes, we will start the study again.
Study Start Date
September 25, 2019 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Parc de Salut Mar
Collaborators
Universitat Oberta de Catalunya, Institut d'Investigacions Biomèdiques August Pi i Sunyer

4. Oversight

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

5. Study Description

Brief Summary
Fibromyalgia (FM) is a generalized, widespread chronic pain disorder and has an estimated prevalence of 2%-4% in the general population. Current pharmacological and psychological interventions frequently produce limited benefits in FM patients. Due to FM's strong association with psychological trauma causing neurobiological alterations in stress response, a trauma-focused psychotherapy is an innovative alternative treatment option. Eye Movement Desensitization and Reprocessing (EMDR) has been recognized by the World Health Organization as a first-line therapeutic tool for post-traumatic stress disorder and first evidence suggests that it is also beneficial for patients with FM. Given the complex etiology of FM, a combination of psychotherapy with other treatment options can maximize a potential therapeutic success. A possible candidate herby is Multifocal transcranial Current Stimulation (MtCS), a non-invasive stimulation technique, which can modify neural activities related to pain and which has shown short-term positive effects on chronic pain and quality of life in FM patients. The patient sample will consist of 45 female patients meeting 2016 American College of Rheumatology criteria for FM based on a clinical interview. They will be randomized to 20 sessions of EMDR plus MtCS or EMDR plus sham-MtCS, or Treatment as Usual (TAU). Therapists, raters, and patients will be kept blind to MtCS treatment conditions. Evaluations will be at baseline, post treatment at 6 months, and follow-up at 12 months. Hypotheses are that EMDR improves pain intensity and clinical symptoms at short and long-term, and that MtCS enhances this effect, which will be superior to MtCS-sham.
Detailed Description
Fibromyalgia (FM) affects 2-4% of the general population with typical symptoms such as generalized and widespread pain, sleep disturbances, problems in memory and attention, anxiety and depression. Pharmacological treatment and psychotherapeutic interventions have produced limited effects so far. Interestingly, lifetime psychosocial adversities are substantially elevated in FM but no interventions are currently offered. Given the complex etiology of FM, combining a psychotherapy with other treatment options can maximize the potential benefit of this intervention. The investigators will test in a marginalized catchment area in Barcelona, whether a trauma-oriented therapy, Eye Movement Desensitization Reprocessing (EMDR), in combination with a non-invasive brain stimulation technique, Multifocal transcranial Current Stimulation (MtCS), can improve typical FM symptoms. Outcomes Primary outcomes: To test whether EMDR plus MtCS or EMDR plus sham-MtCS in comparison to TAU group, improve pain intensity, depressive and anxious symptoms and trauma associated symptoms after therapy and follow-up. To test whether an improvement in pain intensity, depressive and anxious symptoms and trauma associated symptoms can be augmented by simultaneous MtCS comparing EMDR plus MtCS with EMDR plus sham-MtCS after the intervention and whether this is maintained at the follow-up visit. Secondary outcomes: To test whether the EMDR plus MtCS or EMDR plus sham-MtCS incomparison to TAU group, improves more in subjective wellbeing after the treatment, and whether this is maintained at the follow-up visit. Indicators to monitor clinical changes will be performed via various standard self- and hetero-applied scales by blind-to-treatment raters and information provided by patients and the medical chart IT system of our catchment area at baseline (visit 1), post treatment at 6 months (visit 2), and follow-up evaluation at 12 months (visit 3). This multicenter collaborative project will involve the participation of the Psychiatric Department of the Parc de Salut Mar responsible for coordinating the study, the Rheumatologist Department of the Parc de Salut Mar responsible for patient recruitment, the Institut d'investigacions Biomèdiques August Pi i Sunyer (IDIBAPS) responsible for randomization and data base management, and the Cognitive Neuro-Lab responsible for the MtCS stimulation. Design Within a double-blind randomized controlled design, patients will be randomized to one of the following three treatment arms: EMDR with MtCS (20 sessions) vs EMDR with sham-MtCS (20 sessions) vs TAU. Psychotherapists, raters, and patients will be kept blind for MtCS treatment conditions until the end of the trial. Participants The patient sample will consist of 45 females fulfilling the 2016 American College of Rheumatology criteria for FM based on clinical interview (Wolfe et al, 2010). Interventions EMDR therapy Multifocal transcranial Current Stimulation (MtCS) Treatment as Usual Randomizations The main analysis will be the comparison between patients assigned to EMDR vs not assigned to EMDR, and the secondary analysis will be, among patients assign to EMDR, the comparison between patients with FM assigned to active MtCS vs patients with FM assigned to sham MtCS. Therefore, the investigators will not randomly assign the individuals to one of the three arms but, rather, will randomize patients meeting the inclusion criteria twice: they will first randomize them to EMDR vs non-EMDR, and then will randomize those in the EMDR group to active MtCS or sham MtCS. For the sake of brevity, the investigators describe here only the randomization to EMDR vs non-EMDR, because the randomization to active MtCS vs. sham MtCS is identical. The first two patients will be randomly allocated to EMDR with p=2/3. For each subsequent patient, the following biased coin algorithm will be applied. If a group includes at least two more patients than it would have to have to maintain the ratio 2 EMDR / 1 control, the patient will be randomly assigned to the other group with p=0.6. Otherwise, the researchers will simulate that the new patient is allocated to EMDR and calculate the between-group standardized difference in pain intensity variable, will then simulate that the new patient is allocated to non-EMDR and recalculate the difference, and finally randomly allocate the patient to the group associated to the smallest difference with p=0.6. This strategy decreases prognostic imbalances between groups because it decreases differences in potential confounders but it still includes randomization. Computation of sample size The main tests of the study will consist in assessing whether patients assigned to EMDR show different levels of pain intensity variable using standard formula, the total sample size required to detect large to very large effect size differences (Cohen's d ≥ 1) between two groups with a significance level of 0.05 is 13 and 26. Assuming 15% dropouts, the researchers will aim to randomize 45 patients, i.e. 15 and 30 per arm. Statistical Analysis The distribution of socio-demographic and clinical characteristics between groups at baseline will be summarized using descriptive statistics. The change in clinical and functional variables from the baseline evaluation to post intervention will be analyzed using linear model t-tests, including as regressors of no interest the potential confounders (age, pain score, anxiety and depression severity, and number of years in education). The statistical software used for the analysis will be the latest available version of R. The investigators will conduct an intention to treat (ITT) analysis, and will use the "Last Observation Carried Forward" (LOCF) method for losses at follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia, Psychological Trauma, Depressive Symptoms, Anxiety
Keywords
Fibromyalgia, Psychological trauma, Posttraumatic stress disorder, Major depressive disorder, Anxiety disorder, Eye Movement Desensitization and Reprocessing, Multifocal transcranial Current Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
The participant and the care provider will be blind to the MtCS condition, whereas the investigator (the rater) will be blind to both conditions.
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EMDR plus MtCS
Arm Type
Active Comparator
Arm Description
MtCS stimulation will consist of 1mA MtDCS for 20 minutes applied immediately before EMDR sessions.
Arm Title
EMDR plus sham-MtCS
Arm Type
Placebo Comparator
Arm Description
Sham stimulation will consist of inactive MtDCS for 20 minutes applied immediately before EMDR sessions
Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
Patients in this condition will not receive EMDR nor MtCS sessions, and will continue to attend their regular visits with rheumatology and psychiatry. The patients from the TAU group will have the choice to attend 10 sessions of EMDR group therapy when the research project finishes.
Intervention Type
Behavioral
Intervention Name(s)
Eye Movement Desensitization and Reprocessing therapy
Other Intervention Name(s)
EMDR
Intervention Description
EMDR is a psychotherapeutic approach using a standardized 8-phase protocol to alleviate the distress associated with traumatic memories, facilitating the access to and processing of traumatic memories. Patients will receive 20 individual EMDR sessions of 60 minutes each using the standard protocol, as well as a specific pain protocol and the fibromyalgia protocol. EMDR is an integrative psychotherapy that uses standardized protocols and elements of cognitive-behavioral, interpersonal, and body-centered therapies, as well as dual stimulation (e.g., side-to-side eye movements). The current standard protocol includes eight phases: Patient history. Patient preparation. Patient assessment. Memory desensitization. Installing the positive cognition. Body scan. Closure. Reevaluation.
Intervention Type
Other
Intervention Name(s)
Multifocal transcranial Current Stimulation
Other Intervention Name(s)
MtCS
Intervention Description
MtCS represents a promising intervention option, given its capacity to modulate cerebral excitability in a simple, safe manner. F3 anodal; AF3, FC1, FC3, FC5, F5, return montage will be used with the anode over the left DLPFC. Half of the patients will receive active stimulation and the other half sham stimulation. Active stimulation will consist of 1mA MtDCS for 20 minutes applied immediately before EMDR sessions. The same protocol and montage will be used for sham stimulation.
Primary Outcome Measure Information:
Title
Change in pain assessed with the Visual Analogic Scale Questionnaire.
Description
Severity and changes in pain intensity will be assessed with the Visual Analogic Scale (rated in a continuum from 0 to 10).
Time Frame
Change from baseline to visits at 6 and 12 months
Title
Change in pain assessed with the Pain Dissability Index.
Description
Severity and changes in pain intensity will be assessed with the Pain Disability Index (7 items rated from 0 to 10, making a total score from 0 to 70).
Time Frame
Change from baseline to visits at 6 and 12 months
Title
Change in pain assessed with the Fibromyalgia Impact Questionnaire.
Description
Severity and changes in pain intensity will be assessed with the Fibromyalgia Impact Questionnaire (the first items is rated from 0 to 4, the second from 0 to 7 and the third from 0 to 5; whereas the other 7 items are rated from 0 to 10, with a cut-off score of 50).
Time Frame
Change from baseline to visits at 6 and 12 months
Title
Change in depressive symptoms assessed by with the Hospital Anxiety and Depression Scale
Description
Severity and changes in depressive symptoms will be evaluated with the Hospital Anxiety and Depression Scale. Items are rated on a 4-point Likert scale from 0 and 3, yielding a total score ranging from 0 to 21 and a cut-off score of 8 indicating probable clinical symptoms.
Time Frame
Change from baseline to visits at 6 and 12 months
Title
Change in anxious symptoms evaluated with the Hospital Anxiety and Depression Scale.
Description
Severity and changes in anxious symptoms will be evaluated with the Hospital Anxiety and Depression Scale. Items are rated on a 4-point Likert scale from 0 and 3, yielding a total score ranging from 0 to 21 and a cut-off score of 8 indicating probable clinical symptoms.
Time Frame
Change from baseline to visits at 6 and 12 months
Title
Change in trauma associated symptoms assessed with the Impact of Events Scale-Revised.
Description
Psychological trauma will be evaluated using the Impact of Events Scale-Revised. This scale consists in 22-item to determine frequency and impact of posttraumatic symptoms experienced, with subscales of intrusion, avoidance and hyperarousal, each scored on a 5-point Likert scale, yielding a score for each subscale and a total score. This scale has a scoring range of 0 to 88. On this test, scores that exceed 24 can be quite meaningful. High scores have the following associations: 24 or more PTSD is a clinical concern. Those with scores this high who do not have full PTSD will have partial PTSD or at least some of the symptoms; 33 and above represents the best cutoff for a probable diagnosis of PTSD; 37 or more this is high enough to suppress your immune system's functioning (even 10 years after an impact event).
Time Frame
Change from baseline to visits at 6 and 12 months
Secondary Outcome Measure Information:
Title
Change in subjective wellbeing measured with the Satisfaction With Life Scale.
Description
The improvement of subjective wellbeing will be evaluated using the Satisfaction With Life Scale. This scale is completed by 5 items rated from 1 (totally agree) to 5 (totally disagree), with a maximum score of 25.
Time Frame
Change from baseline to visits at 6 and 12 months
Title
Change in insomnia symptoms assessed with the Athens Insomnia Scale.
Description
The improvement of insomnia symptoms will be evaluated using the Athens Insomnia Scale. This scale is completed by 8 items rated from 0 to 3, with a maximum score of 24.
Time Frame
Change from baseline to visits at 6 and 12 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
The relevance of the current proposal is underscored by a recent review (Borchers & Gershwin, 2015) on FM, where the authors highlight that it is a frequent disorder with mainly women of low educational level and socio-economic status affected.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18 and 70 years old Mean pain score of at least 4 on the visual analog scale (VAS) in the two weeks preceding the clinical trial Presence of one or more traumatic events causing current trauma-related symptoms Current clinical symptoms of depression and/or anxiety 2 weeks of stable medication Exclusion Criteria: Comorbid autoimmune or chronic inflammatory disease Neurological or serious medical diseases Bipolar disorder, schizoaffective disorder and schizophrenia Suicidal ideation Previous EMDR therapy Substance abuse/dependency within 1 month prior to participation (except for nicotine abuse/dependency), Pending FM-related litigation or disability Metallic implants in the head Positive test for pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benedikt L. Amann, M.D.
Organizational Affiliation
Parc de Salut Mar
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Forum (Parc de Salut Mar)
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08019
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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27432773
Citation
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Borchers AT, Gershwin ME. Fibromyalgia: A Critical and Comprehensive Review. Clin Rev Allergy Immunol. 2015 Oct;49(2):100-51. doi: 10.1007/s12016-015-8509-4.
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URL
https://www.mscbs.gob.es/estadEstudios/estadisticas/docs/CIE9MC_8ed.pdf
Description
World Health Organization. 2012. Clasificación Internacional de Enfermedades. 9a Modific. ed. Secretaría Ministerio de Sanidad, Política Social e Igualdad. Madrid.

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Augmentation of EMDR With MtCS in the Treatment of Fibromyalgia

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