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.
Fibromyalgia (FM) affects 2-4% of the general population with typical symptoms such as generalized and widespread pain, sleep disturbances, problems in memory and attention, anxiety and depression. Pharmacological treatment and psychotherapeutic interventions have produced limited effects so far. Interestingly, lifetime psychosocial adversities are substantially elevated in FM but no interventions are currently offered. Given the complex etiology of FM, combining a psychotherapy with other treatment options can maximize the potential benefit of this intervention. The investigators will test in Barcelona, whether a trauma-oriented therapy, Eye Movement Desensitization Reprocessing (EMDR), in combination with a non-invasive brain stimulation technique, transcranial Direct Current Stimulation (tDCS), can improve typical FM symptoms. Outcomes Primary outcomes: 1. To test whether EMDR plus tDCS or EMDR plus sham-tDCS in comparison to TAU group, improve pain intensity, depressive and anxious symptoms and trauma associated symptoms after therapy and follow-up. 2. To test whether an improvement in pain intensity, depressive and anxious symptoms and trauma associated symptoms can be augmented by simultaneous tDCS comparing EMDR plus tDCS with EMDR plus sham-tDCS after the intervention and whether this is maintained at the follow-up visit. Secondary outcomes: 3. To test whether the EMDR plus tDCS or EMDR plus sham-tDCS in comparison to TAU group, improves more in subjective wellbeing after the treatment, and whether this is maintained at the follow-up visit. Indicators to monitor clinical changes will be performed via various standard self- and hetero-applied scales by blind-to-treatment raters and information provided by patients and the medical chart IT system of our catchment area at baseline (visit 1), post treatment at 6 months (visit 2), and follow-up evaluation at 12 months (visit 3). This multicenter collaborative project will involve the participation of the Psychiatric Department of the Parc de Salut Mar responsible for coordinating the study, the Rheumatology Department of the Parc de Salut Mar responsible for patient recruitment, and the Cognitive Neuro-Lab of the Universitat Oberta de Catalunya for guidance and council on tDCS use. Design Within a double-blind randomized controlled design, patients will be randomized to one of the following three treatment arms: EMDR with tDCS (20 sessions) vs EMDR with sham-tDCS (20 sessions) vs TAU. Psychotherapists, raters, and patients will be kept blind for tDCS treatment conditions until the end of the trial. Participants The patient sample will consist of 96 females fulfilling the 2016 American College of Rheumatology criteria for FM based on clinical interview (Wolfe et al, 2010). Interventions * EMDR therapy * transcranial Direct Current Stimulation (tDCS) * Treatment as Usual Randomizations Participants were randomly assigned to one of the three study groups using REDCap's stratified randomization module to ensure balanced allocation in terms of Revised Fibromyalgia Impact Questionnaire (FIQ-R) score and education level. When a new participant is enrolled, REDCap identifies their stratum based on the data for these two variables, then it assigns them to a study arm using block randomization within that stratum, favoring the arm with the fewest current assignments to maintain balance. The allocation sequence is concealed from outcome raters until participants have finished the trial. This randomization module enforces balance by prioritizing equal group sizes within strata, even with uneven stratum sizes, it provides real-time adaptations by adjusting assignments dynamically as participants enroll and it logs all randomization events for reproducibility purposes. Computation of sample size The main tests of the study will consist of assessing whether patients assigned to EMDR show different levels in the pain intensity variable using a standard formula for two-tailed t-tests. The total sample size required to detect large to very large effect size differences (Cohen's d ≥ 1) between three groups with a significance level of 0.05 and statistical power of 80% is 28. Assuming 15% dropouts, we will aim to randomize 96 patients, meaning 32 per group. Statistical Analysis The distribution of socio-demographic and clinical characteristics between groups at baseline will be summarized using descriptive statistics. The change in clinical and functional variables from the baseline evaluation to post intervention will be analyzed using linear model t-tests, including as regressors of no interest the potential confounders (age, pain score, anxiety and depression severity, and number of years in education). The statistical software used for the analysis will be the latest available version of R. The investigators will conduct an intention to treat (ITT) analysis, and will use the "Last Observation Carried Forward" (LOCF) method for losses at follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
96
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.
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.
Centre Forum (Parc de Salut Mar)
Barcelona, Catalonia, Spain
RECRUITINGChange 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 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.
Time frame: 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.
Time frame: 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"
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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".
Time frame: 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?"
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Change from baseline to visits at 6 and 12 months
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 months
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 months
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.
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.
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Time frame: Change from baseline to 6 and 12 months.
Change in self-esteem assessed with The Rosenberg Self-Esteem Scale (RSE).
The RSE consists of ten items that assess an individual's overall feelings of self-worth and self-acceptance. The scale covers both positive and negative aspects of self-esteem, it uses a 4 point Likert scale with higher scores indicating greater levels of self-esteem; from 30 to 40 points: High self-esteem, 26 to 29: average self-esteem, \< 25: low self-esteem. The RSE is frequently utilized in research and clinical settings to evaluate self-esteem levels across various populations and to assess the impact of interventions aimed at improving self-esteem.
Time frame: Change from baseline to 6 and 12 months.
Change in cognitive function assessed with The Screen for Cognitive Impairment in Psychiatry (SCIP).
The SCIP is a screening tool used to assess cognitive function in psychiatric patients. It consists of a series of brief cognitive tests designed to evaluate various cognitive domains, including memory, attention, executive function, and language. The SCIP is used by mental health professionals to quickly identify cognitive deficits in patients with psychiatric disorders, which can help inform treatment planning and intervention strategies. The total score for the SCIP can range from 0 to 100, with higher scores indicating better cognitive performance.
Time frame: Change from baseline to 6 and 12 months.