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The efficacy of adding group behavioral activation to usual care in patients with fibromyalgia and major depression: design and protocol for a randomized clinical trial

BACKGROUND: Fibromyalgia and major depression frequently co-occur. Patients with both conditions have a worse prognosis and higher disability, and their treatment options are scarce. Behavioral activation (BA) may be an especially useful intervention for these patients, as it targets mechanisms of a...

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Autores principales: Gómez-Pérez, Lydia, Vergés, Alvaro, Vázquez-Taboada, Ana Rocío, Durán, Josefina, González Tugas, Matías
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6262951/
https://www.ncbi.nlm.nih.gov/pubmed/30486843
http://dx.doi.org/10.1186/s13063-018-3037-1
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author Gómez-Pérez, Lydia
Vergés, Alvaro
Vázquez-Taboada, Ana Rocío
Durán, Josefina
González Tugas, Matías
author_facet Gómez-Pérez, Lydia
Vergés, Alvaro
Vázquez-Taboada, Ana Rocío
Durán, Josefina
González Tugas, Matías
author_sort Gómez-Pérez, Lydia
collection PubMed
description BACKGROUND: Fibromyalgia and major depression frequently co-occur. Patients with both conditions have a worse prognosis and higher disability, and their treatment options are scarce. Behavioral activation (BA) may be an especially useful intervention for these patients, as it targets mechanisms of action that seem to be common to both disorders. Nevertheless, its efficacy has not been examined in people with both conditions. We describe the design and rationale of a randomized clinical trial aimed to evaluate the efficacy of adding BA (applied in groups) to usual care in order to reduce the severity of depressive symptoms (primary outcome) among Chilean women with fibromyalgia and major depression (N = 90). Pain intensity, fibromyalgia impact, pain catastrophizing and hypervigilance, physical health symptoms, environmental reward, and BA will be evaluated as secondary outcomes. METHODS: Women will be randomized to an experimental arm (n = 45) which will receive usual care (UC) for fibromyalgia with comorbid depression plus BA; and a comparison arm, which will receive only UC for fibromyalgia with comorbid depression (n = 45). Outcome assessment will take place at four time points: (1) at baseline, (2) when the experimental arm is under treatment (between sessions 6 and 7), (3) immediately after the experimental arm complete the treatment, and (4) at a 3-month follow-up. The following instruments will be used: Chilean version of the Patient Health Questionnaire-9 (PHQ-9), Composed Pain Intensity Index, Fibromyalgia Impact Questionnaire Revised (FIQ-R), Pain Catastrophizing Scale (PCS), Pain Vigilance and Awareness Questionnaire (PVAQ), Patient Health Questionnaire (PHQ-15), Reward Probability Index (RPI), and the Activation subscale of the Behavioral Activation for Depression Scale (BADS). DISCUSSION: We expect that, after treatment, the group receiving BA should experience greater reductions in the primary and secondary outcomes than the group receiving only UC. These reductions should be both statistically and clinically significant and will be maintained at follow-up. This study will contribute to facilitate the integrated treatment of fibromyalgia and depression. TRIAL REGISTRATION: ClinicalTrials.gov under the name “Testing Interventions for Patients with Fibromyalgia and Depression,” Identifier: NCT03207828. Registered on 5 July 2017 (last update posted 21 September 2017). ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-018-3037-1) contains supplementary material, which is available to authorized users.
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spelling pubmed-62629512018-12-10 The efficacy of adding group behavioral activation to usual care in patients with fibromyalgia and major depression: design and protocol for a randomized clinical trial Gómez-Pérez, Lydia Vergés, Alvaro Vázquez-Taboada, Ana Rocío Durán, Josefina González Tugas, Matías Trials Study Protocol BACKGROUND: Fibromyalgia and major depression frequently co-occur. Patients with both conditions have a worse prognosis and higher disability, and their treatment options are scarce. Behavioral activation (BA) may be an especially useful intervention for these patients, as it targets mechanisms of action that seem to be common to both disorders. Nevertheless, its efficacy has not been examined in people with both conditions. We describe the design and rationale of a randomized clinical trial aimed to evaluate the efficacy of adding BA (applied in groups) to usual care in order to reduce the severity of depressive symptoms (primary outcome) among Chilean women with fibromyalgia and major depression (N = 90). Pain intensity, fibromyalgia impact, pain catastrophizing and hypervigilance, physical health symptoms, environmental reward, and BA will be evaluated as secondary outcomes. METHODS: Women will be randomized to an experimental arm (n = 45) which will receive usual care (UC) for fibromyalgia with comorbid depression plus BA; and a comparison arm, which will receive only UC for fibromyalgia with comorbid depression (n = 45). Outcome assessment will take place at four time points: (1) at baseline, (2) when the experimental arm is under treatment (between sessions 6 and 7), (3) immediately after the experimental arm complete the treatment, and (4) at a 3-month follow-up. The following instruments will be used: Chilean version of the Patient Health Questionnaire-9 (PHQ-9), Composed Pain Intensity Index, Fibromyalgia Impact Questionnaire Revised (FIQ-R), Pain Catastrophizing Scale (PCS), Pain Vigilance and Awareness Questionnaire (PVAQ), Patient Health Questionnaire (PHQ-15), Reward Probability Index (RPI), and the Activation subscale of the Behavioral Activation for Depression Scale (BADS). DISCUSSION: We expect that, after treatment, the group receiving BA should experience greater reductions in the primary and secondary outcomes than the group receiving only UC. These reductions should be both statistically and clinically significant and will be maintained at follow-up. This study will contribute to facilitate the integrated treatment of fibromyalgia and depression. TRIAL REGISTRATION: ClinicalTrials.gov under the name “Testing Interventions for Patients with Fibromyalgia and Depression,” Identifier: NCT03207828. Registered on 5 July 2017 (last update posted 21 September 2017). ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-018-3037-1) contains supplementary material, which is available to authorized users. BioMed Central 2018-11-29 /pmc/articles/PMC6262951/ /pubmed/30486843 http://dx.doi.org/10.1186/s13063-018-3037-1 Text en © The Author(s). 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Gómez-Pérez, Lydia
Vergés, Alvaro
Vázquez-Taboada, Ana Rocío
Durán, Josefina
González Tugas, Matías
The efficacy of adding group behavioral activation to usual care in patients with fibromyalgia and major depression: design and protocol for a randomized clinical trial
title The efficacy of adding group behavioral activation to usual care in patients with fibromyalgia and major depression: design and protocol for a randomized clinical trial
title_full The efficacy of adding group behavioral activation to usual care in patients with fibromyalgia and major depression: design and protocol for a randomized clinical trial
title_fullStr The efficacy of adding group behavioral activation to usual care in patients with fibromyalgia and major depression: design and protocol for a randomized clinical trial
title_full_unstemmed The efficacy of adding group behavioral activation to usual care in patients with fibromyalgia and major depression: design and protocol for a randomized clinical trial
title_short The efficacy of adding group behavioral activation to usual care in patients with fibromyalgia and major depression: design and protocol for a randomized clinical trial
title_sort efficacy of adding group behavioral activation to usual care in patients with fibromyalgia and major depression: design and protocol for a randomized clinical trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6262951/
https://www.ncbi.nlm.nih.gov/pubmed/30486843
http://dx.doi.org/10.1186/s13063-018-3037-1
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