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

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.

A provincial adaptation of clinical practice guidelines for depression in primary care: a case illustration of the ADAPTE method.

RATIONALE, AIMS AND OBJECTIVES: Mental health services for patients with a major depressive disorder are commonly delivered by primary care. To support the uptake of clinical practice guidelines in primary care, we developed and disseminated a practice protocol for depression tailored for a multidisciplinary audience of primary mental health care providers with the ADAPTE methodology. The research questions addressed in this study aimed at examining the experience of the development process of a mental health practice protocol in terms of adaptation, facilitation and implementation. METHODS: We present a descriptive case study of the development and implementation of a practice protocol for major depressive disorder for primary mental health care in the organizational and cultural context of the province of Québec (Canada), following the steps of the ADAPTE methodology. An expert committee composed of general practitioners, mental health specialists, health care administrators and decision makers at regional and provincial levels participated in the protocol development process. RESULTS: The practice protocol was based on two clinical practice guidelines: the NICE guideline on the treatment and management of depression in adults (2009, 2010) and the Canadian Network for Mood and Anxiety Treatments clinical guidelines for the management of major depressive disorder in adults (2009). A stepped care model was embedded in the protocol to facilitate the implementation of clinical recommendations in primary mental health care. A multifaceted dissemination strategy was used to support the uptake of the protocol recommendations in clinical practice. CONCLUSIONS: The ADAPTE methodology provided structure, rigour and efficiency to the trans-contextual adaptation of guideline recommendations. We will share the challenges associated with the adaptation of clinical recommendations and organizational strategies for a mental health guideline, and the dissemination of the practice protocol in primary care.