A pragmatic randomized controlled trial of a group self-management support program versus treatment-as-usual for anxiety disorders: study protocol

• Published in: BMC psychiatry Vol. 22; no. 1; pp. 135 - 13
• Main Authors: Roberge, Pasquale, Houle, Janie, Provost, Jean-Rémy, Coulombe, Simon, Beaudin, Annie, Bower, Peter, Lemyre, Félix Camirand, Drapeau, Martin, Drouin, Marc-Simon, Hudon, Catherine, Provencher, Martin D., Vasiliadis, Helen-Maria
• Format: Journal Article
• Language: English
• Published: London BioMed Central 21.02.2022; BioMed Central Ltd; BMC
• Subjects: Adult; Agoraphobia - therapy; Anxiety; Anxiety disorders; Anxiety Disorders - psychology; Anxiety Disorders - therapy; Care and treatment; Chronic Disease; Evaluation; Group counseling; Group intervention; Humans; Medicine; Medicine & Public Health; Methods; Multicenter Studies as Topic; Panic Disorder; Pragmatic Clinical Trials as Topic; Pragmatic trial; Psychiatry; Psychotherapy; Quality of Life; Self-care, Health; Self-Management; Self-management support; Study Protocol; Testing; Transdiagnostic; Treatment Outcome; Web-based intervention; Canada; Pragmatic trial; Transdiagnostic; Web-based intervention; Anxiety disorders; Self-management support; Group intervention
• ISSN: 1471-244X; 1471-244X
• DOI: 10.1186/s12888-021-03675-4

Background The integration of a personal recovery-oriented practice in mental health services is an emerging principle in policy planning. Self-management support (SMS) is an intervention promoting recovery that aims at educating patients on the nature of their mental disorder, improving their strategies to manage their day-to-day symptoms, fostering self-efficacy and empowerment, preventing relapse, and promoting well-being. While SMS is well established for chronic physical conditions, there is a lack of evidence to support the implementation of structured SMS programs for common mental disorders, and particularly for anxiety disorders. This study aims to examine the effectiveness of a group-based self-management support program for anxiety disorders as an add-on to treatment-as-usual in community-based care settings. Methods/design We will conduct a multicentre pragmatic randomized controlled trial with a pre-treatment, post-treatment (4-month post-randomization), and follow-ups at 8, 12 and 24-months. Treatment and control groups a) group self-management support (10 weekly 2.5-h group web-based sessions with 10–15 patients with two trained facilitators); b) treatment-as-usual. Participants will include adults meeting DSM-5 criteria for Panic Disorder, Agoraphobia, Social Anxiety Disorder, and/or Generalized Anxiety Disorder. The primary outcome measure will be the Beck Anxiety Inventory ; secondary outcome measures will comprise self-reported instruments for anxiety and depressive symptoms, recovery, self-management, quality of life, and service utilisation. Statistical analysis Data will be analysed based on intention-to-treat with a mixed effects regression model accounting for between and within-subject variations in the effects of the intervention. Discussion This study will contribute to the limited knowledge base regarding the effectiveness of structured group self-management support for anxiety disorders. It is expected that changes in patients’ self-management behaviour will lead to better anxiety management and, consequently, to improved patient outcomes. Trial registration ClinicalTrials.gov: NCT05124639 . Prospectively registered 18 November 2021.