Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

transcranial Direct Current Stimulation: 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.

Study 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.

Eligibility

Primary outcome measure(s)

• Change in severity and in pain intensity as measured by the Visual Analogue Scale (VAS) — Change from baseline to visits at 6 and 12 months
  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 in physical impairment due to FM assessed by The Revised Fibromyalgia Impact Questionnaire (FIQ-R) — Change from baseline to visits at 6 and 12 months
  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 in catastrophic thinking related to pain experiences assessed by the Pain Catastrophizing Scale (PCS) — Change from baseline to visits at 6 and 12 months
  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 in the impact of fatigue as assessed by the Brief Fatigue Inventory (BFI) — Change from baseline to visits at 6 and 12 months
  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"
• PTSD diagnosis assessed by the Global Evaluation of Posttraumatic Stress (EGEP-5) — Change from baseline to 6 and 12 months
  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.
• Complex PTSD diagnosis assessed by The International Trauma Questionnaire (ITQ) — Measure at baseline
  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.
• Change in PTSD symptoms as measured by the Posttraumatic Stress Disorder Checklist (PCL-5) — Change from baseline to visits at 6 and 12 months
  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 in subjective perceived distress assessed by Subjective unit of distress (SUD) — Change from baseline to visits at 6 and 12 months
  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.
• Quantifying childhood trauma assessed by The Childhood Trauma Questionnaire (CTQ) — Measure at baseline.
  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".
• Assessing lifetime trauma with the Timeline of traumatic experiences — Measure at baseline
  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?"
• Change in depersonalization symptoms assessed by The Cambridge Depersonalization Scale (CDS) — Change from baseline to 6 and 12 months.
  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 in somatoform dissociation symptoms assessed by Somatoform Dissociation Questionnaire 20 (SDQ-20) — Change from baseline to visits at 6 and 12 months
  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 in anxious and depressive symptoms assessed by with the Hospital Anxiety and Depression Scale — Change from baseline to visits at 6 and 12 months
  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.

Trial sites (1)

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