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  Marc-Simon Drouin⁴  Janie Houle⁴  Martin Drapeau⁵  Simon Coulombe⁶  Peter Bower⁷  Annie Beaudin⁸  Jean-Rémy Provost⁸  Martin D. Provencher⁹ 

[1] Centre de recherche Charles-Le Moyne, Department of Community Health Sciences, Faculty of Medicine and Health Sciences, Université de Sherbrooke, 3001, 12th Avenue North, J1H 5N4, Sherbrooke (Quebec), Canada;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, 3001, 12th Avenue North, J1H 5N4, Sherbrooke (Quebec), Canada;Department of Mathematics, Faculty of Sciences, Centre de recherche du Centre hospitalier universitaire de Sherbrooke (CRCHUS), Université de Sherbrooke, 2500, boul. de l’Université, J1K 2R1, Sherbrooke (Quebec), Canada;Department of Psychology, Faculty of Social Sciences, Université du Québec à Montréal, C.P. 8888, succ. Centre-ville, H3C 3P8, Montréal (Quebec), Canada;Departments of counselling psychology and psychiatry, McGill University, 3700 McTavish, H3A 1Y2, Montreal, Quebec, UK;Département des Relations Industrielles, Université Laval, Pavillon J.-A.-DeSève, 1025, avenue des Sciences-Humaines, G1V 0A6, Québec, Canada;VITAM – Centre de recherche en santé durable, Québec, Canada;National Institute of Health Research School for Primary Care Research, The University of Manchester, M13 9PL, Manchester, UK;Relief, 418, rue Sherbrooke Est, bur. 300, H2L 1J6, Montréal (Québec), Canada;VITAM – Centre de recherche en santé durable, Québec, Canada;School of Psychology, Faculty of Social Sciences, Université Laval, 2325, rue des Bibliothèques, G1V 0A6, Québec, Canada;

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: Springer

【 摘 要 】

BackgroundThe 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/designWe 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 groupsa) 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 analysisData 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.DiscussionThis 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 registrationClinicalTrials.gov: NCT05124639. Prospectively registered 18 November 2021.

【 授权许可】

CC BY