Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorParc de Salut Mar
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Comorbid autoimmune or chronic inflammatory disease
Neurological or serious medical diseases
Bipolar disorder, schizoaffective disorder and schizophrenia
Suicidal ideation
Trial design
Design model
Parallel
Treatments tested in this trial
Eye Movement Desensitization and Reprocessing therapy
BehavioralEMDR 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
Other interventiontDCS 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.
Treatment groups
96 Participants
are divided into 3 treatment groupsGroup A: EMDR plus tDCSActive comparator 2 interventions
Group B: EMDR plus sham-tDCSPlacebo comparator 1 intervention
Group C: Treatment as UsualNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Change from baseline to visits at 6 and 12 months2
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.
Time frame
Change from baseline to visits at 6 and 12 months3
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.
Time frame
Change from baseline to visits at 6 and 12 months4
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"
Time frame
Change from baseline to visits at 6 and 12 monthsSecondary outcomes
1
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.Higher scores mean greater satisfaction.
Time frame
Change from baseline to visits at 6 and 12 months2
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. Higher scores mean greater impact of insomnia.
Time frame
Change from baseline to visits at 6 and 12 months3
Change in Self-care assessed with The González self-care scale.
This Scale consists of 31 items ona 1 to 7 point Likert scale, grouped into six different components, addressing various aspects of self-care: (1) Self-Destruction: Refers to behaviors that harm us in some way; (2) Lack of Tolerance for Positive Affect: Refers to difficulty in receiving affectionate comments or behaviors from others; (3) Problems in Allowing Help: Refers to difficulty in allowing other people to help us; (4) Resentment for Non-Reciprocity: Refers to the anger felt because our needs or emotions have not been attended to or reciprocated; (5) Lack of Positive Activities: Refers to the absence of activities that make us feel good or are healthy for us; (6) Neglecting One's Own Needs: Refers to the difficulty in identifying and satisfying our own needs. A total score above three on each factor is indicative of dysfunctionality.
Time frame
Change from baseline to 6 and 12 months.4
Change in emotion regulation assessed with The Emotion-Regulation Skills Questionnaire (ERSQ).
It consists of 27 items that evaluate various emotion-regulation strategies, including cognitive reappraisal, acceptance, problem-solving, and suppression. It is scored on a Likert Scale from 0 to 4, with a total score being the mean. Higher scores indicate greater emotional regulation. The ERSQ provides insight into an individual's skill level in managing their emotions, which can be useful in clinical settings for developing targeted interventions or in research settings for studying emotion regulation across different populations.
Time frame
Change from baseline to 6 and 12 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Parc de Salut Mar
Lead sponsor
Universitat Oberta de Catalunya
Collaborator
Source ClinicalTrials.gov