The study protocol of a double-blind randomized controlled trial of EMDR and multifocal transcranial current stimulation (MtCS) as augmentation strategy in patients with fibromyalgia
Gardoki-Souto, Itxaso (Hospital del Mar (Barcelona, Catalunya))
Martín de la Torre, Ona (Universitat Oberta de Catalunya)
Hogg, Bridget (Institut Hospital del Mar d'Investigacions Mèdiques)
Redolar-Ripoll, Diego (Universitat Oberta de Catalunya)
Martínez Sadurní, Laura (Institut Hospital del Mar d'Investigacions Mèdiques)
Fontana-McNally, Marta (Institut Hospital del Mar d'Investigacions Mèdiques)
Blanch i Ribas, Josep Maria (Hospital del Mar (Barcelona, Catalunya))
Lupo, Walter (Hospital del Mar (Barcelona, Catalunya))
Pérez, Victor (Universitat Pompeu Fabra)
Radua, Joaquim (King's College London)
Amann, Benedikt L (Institut Hospital del Mar d'Investigacions Mèdiques)
Valiente-Gómez, Alicia (Universitat Autònoma de Barcelona. Departament de Psiquiatria i de Medicina Legal)
Moreno Alcázar, Ana (Universitat Autònoma de Barcelona. Departament de Psiquiatria i de Medicina Legal)

Date:	2024
Abstract:	Fibromyalgia (FM) is a generalized, widespread chronic pain disorder affecting 2. 7% of the general population. In recent years, different studies have observed a strong association between FM and psychological trauma. Therefore, a trauma-focused psychotherapy, such as Eye Movement Desensitization and Reprocessing (EMDR), combined with a non-invasive brain stimulation technique, such as multifocal transcranial current stimulation (MtCS), could be an innovative adjunctive treatment option. This double-blind randomized controlled trial (RCT) analyzes if EMDR therapy is effective in the reduction of pain symptoms in FM patients, and if its potential is boosted with the addition of MtCS. Ninety-six patients with FM and a history of traumatic events will be randomly allocated to the treatment as usual (TAU) condition, EMDR + active-MtCS condition, or EMDR + sham-MtCS condition. Therapists and patients will be kept blind to MtCS conditions, and raters will be kept blind to both EMDR and MtCS. All patients will be evaluated at baseline, post-treatment, and follow-up at 6 months after post-treatment. Evaluations will assess the following variables: sociodemographic data, pain, psychological trauma, sleep disturbance, anxiety and affective symptoms, wellbeing, self-care, emotional regulation, self-esteem, and cognitive functioning. This study will provide evidence of whether EMDR therapy is effective in reducing pain symptoms in FM patients, and whether the effect of EMDR can be enhanced by MtCS. This trial was registered at ClinicalTrials. gov on 2 August 2019, identifier: NCT04084795. The online version contains supplementary material available at 10. 1186/s13063-024-08708-3.
Grants:	Instituto de Salud Carlos III PI23/00072
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Fibromyalgia ; Eye Movement Desensitization and Reprocessing ; Multifocal transcranial current stimulation ; Psychological trauma ; Pain ; Randomized controlled trial
Published in:	Trials, Vol. 25 (december 2024) , ISSN 1745-6215

DOI: 10.1186/s13063-024-08708-3
PMID: 39741323

16 p, 1.1 MB

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