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

BMC Psychiatry

Helen-Maria Vasiliadis¹  Pasquale Roberge²  Catherine Hudon²  Félix Camirand Lemyre³  Janie Houle⁴  Marc-Simon Drouin⁴  Martin Drapeau⁵  Simon Coulombe⁶  Peter Bower⁷  Jean-Rémy Provost⁸  Annie Beaudin⁸  Martin D. Provencher⁹ 

[1] Centre de recherche Charles-Le Moyne, Department of Community Health Sciences, Faculty of Medicine and Health Sciences, Université de Sherbrooke;Department of Family Medicine and Emergency Medicine, Faculty of Medicine and Health Sciences, Centre de recherche du Centre Hospitalier Universitaire de Sherbrooke (CRCHUS), Université de Sherbrooke;Department of Mathematics, Faculty of Sciences, Centre de recherche du Centre hospitalier universitaire de Sherbrooke (CRCHUS), Université de Sherbrooke;Department of Psychology, Faculty of Social Sciences, Université du Québec à Montréal;Departments of counselling psychology and psychiatry, McGill University;Département des Relations Industrielles, Université Laval;National Institute of Health Research School for Primary Care Research, The University of Manchester;Relief;VITAM – Centre de recherche en santé durable;

关键词: Anxiety disorders;    Self-management support;    Pragmatic trial;    Group intervention;    Web-based intervention;    Transdiagnostic;   

DOI  :  10.1186/s12888-021-03675-4

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown