Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia

NCT04084795 | Recruiting

• 1 other identifier: 2019/8772/I
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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 96 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.

Conditions

Fibromyalgia; Psychological Trauma; Depressive Symptoms; Anxiety

Keywords

Fibromyalgia; Psychological trauma; Posttraumatic stress disorder; Major depressive disorder; Anxiety disorder; Eye Movement Desensitization and Reprocessing; transcranial Direct Current Stimulation

Outcome Measures

Primary Outcomes (13)

• Change in severity and in pain intensity as measured by the Visual Analogue Scale (VAS)

  The VAS pain consists of a straight horizontal line anchored between 2 verbal descriptors: "No pain" on the left side and "Unbearable pain" on the right. Scores are interpreted as follows: no pain (0-2), mild pain (2-4), moderate pain (4-6), severe pain (6-8), and maximum pain (8-10). This measure assesses the intensity of the perceived pain over the last 2 weeks.

  Change from baseline to visits at 6 and 12 months

• Change in physical impairment due to FM assessed by The Revised Fibromyalgia Impact Questionnaire (FIQ-R)

  9-item self-administered scale for measuring physical impairment due to FM over the last week. Scores range from 0-100 and higher scores indicate greater impact in functioning.

  Change from baseline to visits at 6 and 12 months

• Change in catastrophic thinking related to pain experiences assessed by the Pain Catastrophizing Scale (PCS)

  13 item self-report questionnaire designed to assess the extent to which individuals magnify, ruminate, and feel helpless about their pain. Scores range from 0-52 with higher scores indicating greater catastrophizing.

  Change from baseline to visits at 6 and 12 months

• Change in the impact of fatigue as assessed by the Brief Fatigue Inventory (BFI)

  9 item self-report questionnaire used to assess the severity and impact of fatigue on individuals in the past 24h, as well as its interference with various aspects of daily life, such as mood, walking ability, work, relationships, and enjoyment of life. Scores range from 0-10 with 0: "no fatigue"; 1-3: "low"; 4-6: "moderate" y 7-10: "severe"

  Change from baseline to visits at 6 and 12 months

• PTSD diagnosis assessed by the Global Evaluation of Posttraumatic Stress (EGEP-5)

  55-item clinician-applied scale to determine current PTSD diagnosis, based on DSM-V criteria. The scale can determine a diagnosis of PTSD, specifying the presence of dissociative symptoms (depersonalization and derealization) and delayed expression.

  Change from baseline to 6 and 12 months

• Complex PTSD diagnosis assessed by The International Trauma Questionnaire (ITQ)

  This 12 item questionnaire is a tool used to evaluate and diagnose complex post-traumatic stress disorder (C-PTSD) and other trauma-related disorders, in terms of ICD-11 classification for mental disorders. It assess the presence and severity of PTSD symptoms, as well as disturbances in self-organization associated with C-PTSD.

  Measure at baseline

• Change in PTSD symptoms as measured by the Posttraumatic Stress Disorder Checklist (PCL-5)

  This scale assesses DSM-5 PTSD symptoms using a 20-item questionnaire. Scores range from 0 to 80, with higher scores indicating greater severity. A cut-off score of 33 is used for diagnosis.

  Change from baseline to visits at 6 and 12 months

• Change in subjective perceived distress assessed by Subjective unit of distress (SUD)

  this scale, ranging from 0 (no distress) to 10 (maximum distress), evaluates the level of subjective perturbation a person experiences when they bring to mind the traumatic event chosen in the EGEP-5 scale.

  Change from baseline to visits at 6 and 12 months

• Quantifying childhood trauma assessed by The Childhood Trauma Questionnaire (CTQ)

  Self-applied scale which includes a 28-item test that measure 5 types of childhood maltreatment: emotional, physical and sexual abuse, and emotional or physical neglect. A 5-point Likert scale (from 1 to 5) is used for the responses which range from "never true" to "very often true". The final scores provide a severity score for each subscale from "none to minimal," "low to moderate," "moderate to severe," and "severe to extreme".

  Measure at baseline.

• Assessing lifetime trauma with the Timeline of traumatic experiences

  The Timeline of traumatic experiences tool was developed specifically for this study and consists of a table that qualitatively compiles different traumatic events that the person may have suffered both in childhood and in adulthood. The table is segmented into 5-year intervals ranging from 0-5 years old to 65-70 years old. Within each segment, participants are asked: "Do you recall experiencing any traumatic or stressful events during this age interval?"

  Measure at baseline

• Change in depersonalization symptoms assessed by The Cambridge Depersonalization Scale (CDS)

  A self-report questionnaire designed to assess the severity of depersonalization symptoms. It consists of 29 items that evaluate various aspects of depersonalization, including feelings of detachment from oneself, altered perceptions of time and space, and experiences of unreality. Each item on the CDS is rated on two Likert scales: one for frequency and one for duration. The total score ranges from 0 to 290. A higher total score indicates greater severity of depersonalization symptoms with a cut-off point of 70 to indicate depersonalization symptoms.

  Change from baseline to 6 and 12 months.

• Change in somatoform dissociation symptoms assessed by Somatoform Dissociation Questionnaire 20 (SDQ-20)

  The SDQ-20 is a 20-item self-report questionnaire measuring somatoform dissociation. Items refer to somatic symptoms and then ask if there is a known cause for them. The items are answered on a 5-point Likert scale and the symptoms with no known cause are summed to achieve the total scorwhich can range from 20 to 100. A higher score indicates a greater degree of somatoform dissociation.

  Change from baseline to visits at 6 and 12 months

• Change in anxious and depressive symptoms assessed by with the Hospital Anxiety and Depression Scale

  Severity and changes in anxious and 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 from baseline to visits at 6 and 12 months

Secondary Outcomes (6)

• Change in subjective wellbeing measured with the Satisfaction With Life Scale.

  Change from baseline to visits at 6 and 12 months

• Change in insomnia symptoms assessed with the Athens Insomnia Scale.

  Change from baseline to visits at 6 and 12 months

• Change in Self-care assessed with The González self-care scale.

  Change from baseline to 6 and 12 months.

• Change in emotion regulation assessed with The Emotion-Regulation Skills Questionnaire (ERSQ).

  Change from baseline to 6 and 12 months.

• Change in self-esteem assessed with The Rosenberg Self-Esteem Scale (RSE).

  Change from baseline to 6 and 12 months.

Study Arms (3)

EMDR plus tDCS

ACTIVE COMPARATOR

tDCS stimulation will consist of 2mA tDCS for 20 minutes applied immediately before EMDR sessions.

Behavioral: Eye Movement Desensitization and Reprocessing therapy; Other: transcranial Direct Current Stimulation

EMDR plus sham-tDCS

PLACEBO COMPARATOR

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

Behavioral: Eye Movement Desensitization and Reprocessing therapy

Treatment as Usual

NO INTERVENTION

Patients in this condition will not receive EMDR nor tDCS sessions, and will continue to attend their regular visits with rheumatology and psychiatry.

Interventions

Eye Movement Desensitization and Reprocessing therapy BEHAVIORAL

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.

Also known as: EMDR

EMDR plus sham-tDCS; EMDR plus tDCS

transcranial Direct Current Stimulation OTHER

tDCS represents a promising intervention option, given its capacity to modulate cerebral excitability in a simple, safe manner. F3 anodal; Fp1, F7, Fc5, AF3, Fc1, Fz, 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 2mA tDCS for 20 minutes applied immediately before EMDR sessions. The same protocol and montage will be used for sham stimulation.

Also known as: tDCS

EMDR plus tDCS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: The relevance of the current proposal is underscored by a 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. Moreover, in Spain, the distribution by sex prevalence has been found to be 4.49% in women; significantly higher than the 0.29% in men (Font Gayà et al., 2020).
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• weeks of stable medication

You may not qualify if:

• Comorbid autoimmune or chronic inflammatory disease
• Neurological or serious medical diseases
• Bipolar disorder, schizoaffective disorder and schizophrenia
• Suicidal ideation
• Previous EMDR therapy in the past two years
• 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
• Skin sensitivity diseases (psoriasis, eczema, dermatitis, etc.)

Sponsors & Collaborators

• Parc de Salut Mar: lead
• Universitat Oberta de Catalunya: collaborator

Study Sites (1)

Centre Forum (Parc de Salut Mar)

Barcelona, Catalonia, 08019, Spain

RECRUITING

Related Publications (15)

• Font Gaya T, Bordoy Ferrer C, Juan Mas A, Seoane-Mato D, Alvarez Reyes F, Delgado Sanchez M, Martinez Dubois C, Sanchez-Fernandez SA, Marena Rojas Vargas L, Garcia Morales PV, Olive A, Rubio Munoz P, Larrosa M, Navarro Ricos N, Sanchez-Piedra C, Diaz-Gonzalez F, Bustabad-Reyes S; Working Group Proyecto EPISER2016. Prevalence of fibromyalgia and associated factors in Spain. Clin Exp Rheumatol. 2020 Jan-Feb;38 Suppl 123(1):47-52. Epub 2020 Jan 8.

  PMID: 31928589 BACKGROUND

• Benor D, Rossiter-Thornton J, Toussaint L. A Randomized, Controlled Trial of Wholistic Hybrid Derived From Eye Movement Desensitization and Reprocessing and Emotional Freedom Technique (WHEE) for Self-Treatment of Pain, Depression, and Anxiety in Chronic Pain Patients. J Evid Based Complementary Altern Med. 2017 Apr;22(2):268-277. doi: 10.1177/2156587216659400. Epub 2016 Jul 20.

  PMID: 27432773 BACKGROUND

• Bernardy K, Klose P, Busch AJ, Choy EH, Hauser W. Cognitive behavioural therapies for fibromyalgia. Cochrane Database Syst Rev. 2013 Sep 10;2013(9):CD009796. doi: 10.1002/14651858.CD009796.pub2.

  PMID: 24018611 BACKGROUND

• 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.

  PMID: 26445775 BACKGROUND

• Burke NN, Finn DP, McGuire BE, Roche M. Psychological stress in early life as a predisposing factor for the development of chronic pain: Clinical and preclinical evidence and neurobiological mechanisms. J Neurosci Res. 2017 Jun;95(6):1257-1270. doi: 10.1002/jnr.23802. Epub 2016 Jul 12.

  PMID: 27402412 BACKGROUND

• Cohen H, Neumann L, Haiman Y, Matar MA, Press J, Buskila D. Prevalence of post-traumatic stress disorder in fibromyalgia patients: overlapping syndromes or post-traumatic fibromyalgia syndrome? Semin Arthritis Rheum. 2002 Aug;32(1):38-50. doi: 10.1053/sarh.2002.33719.

  PMID: 12219319 BACKGROUND

• Collado A, Gomez E, Coscolla R, Sunyol R, Sole E, Rivera J, Altarriba E, Carbonell J, Castells X. Work, family and social environment in patients with Fibromyalgia in Spain: an epidemiological study: EPIFFAC study. BMC Health Serv Res. 2014 Nov 11;14:513. doi: 10.1186/s12913-014-0513-5.

  PMID: 25385047 BACKGROUND

• Crettaz B, Marziniak M, Willeke P, Young P, Hellhammer D, Stumpf A, Burgmer M. Stress-induced allodynia--evidence of increased pain sensitivity in healthy humans and patients with chronic pain after experimentally induced psychosocial stress. PLoS One. 2013 Aug 7;8(8):e69460. doi: 10.1371/journal.pone.0069460. eCollection 2013.

  PMID: 23950894 BACKGROUND

• Hampstead BM, Briceno EM, Mascaro N, Mourdoukoutas A, Bikson M. Current Status of Transcranial Direct Current Stimulation in Posttraumatic Stress and Other Anxiety Disorders. Curr Behav Neurosci Rep. 2016 Jun;3(2):95-101. doi: 10.1007/s40473-016-0070-9. Epub 2016 Mar 28.

  PMID: 29479515 BACKGROUND

• Lumley MA, Schubiner H, Lockhart NA, Kidwell KM, Harte SE, Clauw DJ, Williams DA. Emotional awareness and expression therapy, cognitive behavioral therapy, and education for fibromyalgia: a cluster-randomized controlled trial. Pain. 2017 Dec;158(12):2354-2363. doi: 10.1097/j.pain.0000000000001036.

  PMID: 28796118 BACKGROUND

• O'Connell NE, Marston L, Spencer S, DeSouza LH, Wand BM. Non-invasive brain stimulation techniques for chronic pain. Cochrane Database Syst Rev. 2018 Mar 16;3(3):CD008208. doi: 10.1002/14651858.CD008208.pub4.

  PMID: 29547226 BACKGROUND

• Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140.

  PMID: 20461783 BACKGROUND

• Yavne Y, Amital D, Watad A, Tiosano S, Amital H. A systematic review of precipitating physical and psychological traumatic events in the development of fibromyalgia. Semin Arthritis Rheum. 2018 Aug;48(1):121-133. doi: 10.1016/j.semarthrit.2017.12.011. Epub 2018 Jan 10.

  PMID: 29428291 BACKGROUND

• Gardoki-Souto I, Martin de la Torre O, Hogg B, Redolar-Ripoll D, Martinez Sadurni L, Fontana-McNally M, Blanch JM, Lupo W, Perez V, Radua J, Amann BL, Valiente-Gomez A, Moreno-Alcazar A. The study protocol of a double-blind randomized controlled trial of EMDR and multifocal transcranial current stimulation (MtCS) as augmentation strategy in patients with fibromyalgia. Trials. 2024 Dec 31;25(1):856. doi: 10.1186/s13063-024-08708-3.

  PMID: 39741323 DERIVED

• Gardoki-Souto I, Martin de la Torre O, Hogg B, Redolar-Ripoll D, Valiente-Gomez A, Martinez Sadurni L, Blanch JM, Lupo W, Perez V, Radua J, Amann BL, Moreno-Alcazar A. Augmentation of EMDR with multifocal transcranial current stimulation (MtCS) in the treatment of fibromyalgia: study protocol of a double-blind randomized controlled exploratory and pragmatic trial. Trials. 2021 Jan 29;22(1):104. doi: 10.1186/s13063-021-05042-w.

  PMID: 33514408 DERIVED

Related Links

• World Health Organization. 2012. Clasificación Internacional de Enfermedades. 9a Modific. ed. Secretaría Ministerio de Sanidad, Política Social e Igualdad. Madrid.

MeSH Terms

Conditions

Fibromyalgia; Psychological Trauma; Depression; Anxiety Disorders; Stress Disorders, Post-Traumatic; Depressive Disorder, Major

Interventions

Eye Movement Desensitization Reprocessing; Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Electroshock; Psychological Techniques

Study Officials

• Benedikt L. Amann, M.D.

  Parc de Salut Mar

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alicia Valiente Gómez, M.D.

CONTACT

(0034)933268500; avaliente@researchmar.net

Benedikt L. Amann, M.D.

CONTACT

(0034)933268500; 62517@parcdesalutmar.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participant and the care provider will be blind to the tDCS condition as sham-tDCS will be used, whereas the Outcomes assessor will be blind to both conditions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: September 10, 2019
• Study Start: January 21, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)