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Trial record 94 of 111 for:    "Depressive Disorder" [DISEASE] AND Behavioral AND Mental | ( Map: Spain )

Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia

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ClinicalTrials.gov Identifier: NCT04084795
Recruitment Status : Recruiting
First Posted : September 10, 2019
Last Update Posted : October 31, 2019
Sponsor:
Collaborators:
Universitat Oberta de Catalunya
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Information provided by (Responsible Party):
Parc de Salut Mar

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 transcranial Direct Current Stimulation (tDCS), 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 tDCS or EMDR plus sham-tDCS, or Treatment as Usual (TAU). Therapists, raters, and patients will be kept blind to tDCS 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 tDCS enhances this effect, which will be superior to tDCS-sham.

Condition or disease Intervention/treatment Phase
Fibromyalgia Psychological Trauma Depressive Symptoms Anxiety Behavioral: Eye Movement Desensitization and Reprocessing therapy Other: Transcranial Direct Current Stimulation Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: The participant and the care provider will be blind to the tDCS condition, whereas the investigator (the rater) will be blind to both conditions.
Primary Purpose: Treatment
Official Title: Augmentation of EMDR With Transcranial Direct Current Stimulation in the Treatment of Fibromyalgia: a Randomized Controlled Trial
Actual Study Start Date : September 25, 2019
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Active Comparator: EMDR plus tDCS
tDCS stimulation will consist of 1mA MtDCS for 20 minutes applied immediately before EMDR sessions.
Behavioral: Eye Movement Desensitization and Reprocessing therapy

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.

Other Name: EMDR

Other: Transcranial Direct Current Stimulation
tDCS represents a promising intervention option, given its capacity to modulate cerebral excitability in a simple, safe manner. We will use a multifocal transcranial direct current stimulation (MtDCS) montage (AF3 anodal, Fp1, AF7, F5, F3, F1, AFz return), intended to target the right 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.
Other Name: tDCS

Placebo Comparator: EMDR plus sham-tDCS
Sham stimulation will consist of inactive MtDCS for 20 minutes applied immediately before EMDR sessions
Behavioral: Eye Movement Desensitization and Reprocessing therapy

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.

Other Name: EMDR

No Intervention: Treatment as Usual
Patients in this condition will not receive EMDR nor tDCS 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.



Primary Outcome Measures :
  1. Change in pain assessed with the Visual Analogic Scale Questionnaire. [ Time Frame: Change from baseline to visits at 6 and 12 months ]
    Severity and changes in pain intensity will be assessed with the Visual Analogic Scale (rated in a continuum from 0 to 10).

  2. Change in pain assessed with the Pain Dissability Index. [ Time Frame: Change from baseline to visits at 6 and 12 months ]
    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).

  3. Change in pain assessed with the Fibromyalgia Impact Questionnaire. [ Time Frame: Change from baseline to visits at 6 and 12 months ]
    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).

  4. Change in depressive symptoms assessed by with the Hospital Anxiety and Depression Scale [ Time Frame: Change from baseline to visits at 6 and 12 months ]
    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.

  5. Change in anxious symptoms evaluated with the Hospital Anxiety and Depression Scale. [ Time Frame: Change from baseline to visits at 6 and 12 months ]
    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.

  6. Change in trauma associated symptoms assessed with the Impact of Events Scale-Revised. [ Time Frame: Change from baseline to visits at 6 and 12 months ]
    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 :
  1. Change in subjective wellbeing measured with the Satisfaction With Life Scale. [ Time Frame: Change from baseline to visits at 6 and 12 months ]
    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.

  2. Change in insomnia symptoms assessed with the Athens Insomnia Scale. [ Time Frame: Change from baseline to visits at 6 and 12 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   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.
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04084795


Contacts
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Contact: Ana Moreno-Alcázar, Ph.D. (0034)933268500 ext 8403 amoreno1@imim.es
Contact: Benedikt L. Amann, M.D. (0034)933268500 ext 8402 62517@parcdesalutmar.cat

Locations
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Spain
Centre Forum (Parc de Salut Mar) Recruiting
Barcelona, Catalunya, Spain, 08019
Contact: Benedikt L. Amann, MD    (0034)933 268 500 ext 8402    62517@parcdesalutmar.cat   
Sponsors and Collaborators
Parc de Salut Mar
Universitat Oberta de Catalunya
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Investigators
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Principal Investigator: Benedikt L. Amann, M.D. Parc de Salut Mar

Additional Information:
Publications:

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Responsible Party: Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT04084795     History of Changes
Other Study ID Numbers: 2019/8772/I
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: October 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Parc de Salut Mar:
Fibromyalgia
Psychological trauma
Posttraumatic stress disorder
Major depressive disorder
Anxiety disorder
Eye Movement Desensitization and Reprocessing
Transcranial Direct Current Stimulation
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms
Mental Disorders
Fibromyalgia
Myofascial Pain Syndromes
Psychological Trauma
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders