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

Publication Type:

Journal Article


BMC Psychiatry, Volume 22, Issue 1, p.135 (2022)


Adult, Agoraphobia, Anxiety Disorders, Chronic Disease, Humans, Multicenter Studies as Topic, Panic Disorder, Quality of Life, Randomized Controlled Trials as Topic, Self-Management, Treatment Outcome


<p><b>BACKGROUND: </b>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.</p><p><b>METHODS/DESIGN: </b>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.</p><p><b>STATISTICAL ANALYSIS: </b>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.</p><p><b>DISCUSSION: </b>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.</p><p><b>TRIAL REGISTRATION: </b>ClinicalTrials.gov: NCT05124639 . Prospectively registered 18 November 2021.</p>

Financement / Soutien / Partenaires

logo FRQ-S logo ctrn logo fci logo cihr irsc logo nserc logo MESISentinelle nord