Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia

Conditions studied

Fibromyalgia, Psychological Trauma, Depressive Symptoms, Anxiety

About this study

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.

Interventions

• 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: 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.

Primary outcomes

• 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)
• 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)
• 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)
• Change in the impact of fatigue as assessed by the Brief Fatigue Inventory (BFI) (Change from baseline to visits at 6 and 12 months)
• PTSD diagnosis assessed by the Global Evaluation of Posttraumatic Stress (EGEP-5) (Change from baseline to 6 and 12 months)
• Complex PTSD diagnosis assessed by The International Trauma Questionnaire (ITQ) (Measure at baseline)
• Change in PTSD symptoms as measured by the Posttraumatic Stress Disorder Checklist (PCL-5) (Change from baseline to visits at 6 and 12 months)
• Change in subjective perceived distress assessed by Subjective unit of distress (SUD) (Change from baseline to visits at 6 and 12 months)