BMC Psychiatry (Feb 2022)

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

  • Pasquale Roberge,
  • Janie Houle,
  • Jean-Rémy Provost,
  • Simon Coulombe,
  • Annie Beaudin,
  • Peter Bower,
  • Félix Camirand Lemyre,
  • Martin Drapeau,
  • Marc-Simon Drouin,
  • Catherine Hudon,
  • Martin D. Provencher,
  • Helen-Maria Vasiliadis

DOI
https://doi.org/10.1186/s12888-021-03675-4
Journal volume & issue
Vol. 22, no. 1
pp. 1 – 13

Abstract

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Abstract 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.

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