A systematic review of precipitating physical and psychological traumatic events in the development of fibromyalgia.
Yarden Yavne, Daniela Amital, Abdulla Watad...
https://pubmed.ncbi.nlm.nih.gov/29428291/Actively Recruiting
Led by Parc de Salut Mar · Updated on 2025-08-03
96
Participants Needed
1
Research Sites
N/A
Total Duration
Fibromyalgia FM is a chronic condition causing widespread pain and affects 2-4% of the general population. It often comes with sleep problems, memory and attention issues, anxiety, and depression. Current drug and psychological treatments often have limited success. Because FM is linked to psychological trauma affecting stress responses, this research evaluates trauma-focused psychotherapy combined with brain stimulation as a new treatment option for women with FM. The trial compares three groups of female participants diagnosed with FM one receiving Eye Movement Desensitization and Reprocessing EMDR therapy plus active transcranial Direct Current Stimulation tDCS, another receiving EMDR plus sham inactive tDCS, and a third group receiving treatment as usual TAU without these interventions. EMDR involves 20 weekly one-hour sessions using a standardized protocol, while tDCS is delivered as 2mA brain stimulation for 20 minutes immediately before each EMDR session. The sham group receives inactive tDCS, and the TAU group continues regular care without these treatments. Participants will be evaluated at the start, after 6 months post-treatment, and at a 12-month follow-up. Assessments include measuring pain intensity, physical function, trauma symptoms, anxiety, depression, fatigue, and wellbeing using various clinical scales. The study also monitors cognitive function, emotion regulation, self-care, and sleep quality. Therapists, patients, and outcome raters will not know which tDCS treatment is given to ensure unbiased results. The total participation lasts up to one year with several in-person assessments.
CONDITIONS
Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia
A
Alicia Valiente Gómez, M.D.
B
Benedikt L. Amann, M.D.
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Parc de Salut Mar
Lead Sponsor
Universitat Oberta de Catalunya
Collaborating Sponsor
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of 20 sessions (exact calendar time not specified)
Participants receive 20 individual EMDR therapy sessions combined with either active or sham transcranial Direct Current Stimulation (tDCS), or continue Treatment as Usual without these interventions.
20 visits (in-person)
Duration - Up to 12 months after treatment
Participants are evaluated for changes in pain intensity, trauma symptoms, and wellbeing at 6 months and 12 months after treatment.
2 visits (in-person) at 6 and 12 months post-treatment
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Lead Sponsor
Universitat Oberta de Catalunya
Collaborating Sponsor