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. 2018 Nov 29;19(1):660.
doi: 10.1186/s13063-018-3037-1.

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

Lydia Gómez-Pérez  1 , Alvaro Vergés  2 , Ana Rocío Vázquez-Taboada  2 , Josefina Durán  3 , Matías González Tugas  4
Affiliations

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

Lydia Gómez-Pérez et al. Trials. .

Abstract

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).

Keywords: Behavioral activation; Chile; Depression; Efficacy; Fibromyalgia; Group intervention.

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Conflict of interest statement

Ethics approval and consent to participate

This study was approved by the Medicine Scientific Ethics Committee (Comité Científico Ético de Medicina) of the Pontificia Universidad Católica de Chile, Santiago, Chile (CÓDIGO 15–221). This committee will be in charge of conducting an audit of the ethical aspects of the trial before its termination. Any protocol modification will be sent to the committee for approval and once it is approved it will be notified to the trial registration agencies. All eligible participants who will be willing to participate will go through an informed consent process, conducted by a research assistant who is not a member of the patient’s medical team. This research will be carried out in accordance with the Declaration of Helsinki.

Consent for publication

Consent for publication will be obtained from each participant prior to participation.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Schedule of enrollment, interventions, and assessment. Abbreviations: PHQ-9 Patient Health Questionnaire-9, FSQ Fibromyalgia Survey Questionnaire, MMSE Mini-Mental State Examination, MINI Mini International Neuropsychiatric Interview, BA Behavioral activation, UC usual care, CPI Composite Pain Index, FIQ-R Fibromyalgia Impact Questionnaire, PCS Pain Catastrophizing Scale, PVAQ Pain Vigilance and Awareness Questionnaire, PHQ-15 The Patient Health Questionnaire, RPI Reward Probability Index, BADS Activation subscale of the Behavioral Activation for Depression Scale, CSQ-8 Client Satisfaction Questionnaire-8, VSSS Verona Service Satisfaction Scale
Fig. 2
Fig. 2
Flowchart of the research according to the Consolidated Standards of Reporting Trials (CONSORT) model
See this image and copyright information in PMC

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