A pragmatic randomized controlled trial of a group self-management support program versus treatment-as-usual for anxiety disorders: study protocol
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 th...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2022-02-01
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| Series: | BMC Psychiatry |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12888-021-03675-4 |
| _version_ | 1818988183053926400 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Pasquale Roberge |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-20T19:18:32Z |
| format | Article |
| id | doaj.art-aac7d1f9f12d4dd6a38eeebbd0d0ec08 |
| institution | Directory Open Access Journal |
| issn | 1471-244X |
| language | English |
| last_indexed | 2024-12-20T19:18:32Z |
| publishDate | 2022-02-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Psychiatry |
| spelling | doaj.art-aac7d1f9f12d4dd6a38eeebbd0d0ec082022-12-21T19:29:04ZengBMCBMC Psychiatry1471-244X2022-02-0122111310.1186/s12888-021-03675-4A pragmatic randomized controlled trial of a group self-management support program versus treatment-as-usual for anxiety disorders: study protocolPasquale Roberge0Janie Houle1Jean-Rémy Provost2Simon Coulombe3Annie Beaudin4Peter Bower5Félix Camirand Lemyre6Martin Drapeau7Marc-Simon Drouin8Catherine Hudon9Martin D. Provencher10Helen-Maria Vasiliadis11Department of Family Medicine and Emergency Medicine, Faculty of Medicine and Health Sciences, Centre de recherche du Centre Hospitalier Universitaire de Sherbrooke (CRCHUS), Université de SherbrookeDepartment of Psychology, Faculty of Social Sciences, Université du Québec à MontréalReliefDépartement des Relations Industrielles, Université LavalReliefNational Institute of Health Research School for Primary Care Research, The University of ManchesterDepartment of Mathematics, Faculty of Sciences, Centre de recherche du Centre hospitalier universitaire de Sherbrooke (CRCHUS), Université de SherbrookeDepartments of counselling psychology and psychiatry, McGill UniversityDepartment of Psychology, Faculty of Social Sciences, Université du Québec à MontréalDepartment of Family Medicine and Emergency Medicine, Faculty of Medicine and Health Sciences, Centre de recherche du Centre Hospitalier Universitaire de Sherbrooke (CRCHUS), Université de SherbrookeVITAM – Centre de recherche en santé durableCentre de recherche Charles-Le Moyne, Department of Community Health Sciences, Faculty of Medicine and Health Sciences, Université de SherbrookeAbstract 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.https://doi.org/10.1186/s12888-021-03675-4Anxiety disordersSelf-management supportPragmatic trialGroup interventionWeb-based interventionTransdiagnostic |
| spellingShingle | 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 A pragmatic randomized controlled trial of a group self-management support program versus treatment-as-usual for anxiety disorders: study protocol BMC Psychiatry Anxiety disorders Self-management support Pragmatic trial Group intervention Web-based intervention Transdiagnostic |
| title | A pragmatic randomized controlled trial of a group self-management support program versus treatment-as-usual for anxiety disorders: study protocol |
| title_full | A pragmatic randomized controlled trial of a group self-management support program versus treatment-as-usual for anxiety disorders: study protocol |
| title_fullStr | A pragmatic randomized controlled trial of a group self-management support program versus treatment-as-usual for anxiety disorders: study protocol |
| title_full_unstemmed | A pragmatic randomized controlled trial of a group self-management support program versus treatment-as-usual for anxiety disorders: study protocol |
| title_short | A pragmatic randomized controlled trial of a group self-management support program versus treatment-as-usual for anxiety disorders: study protocol |
| title_sort | pragmatic randomized controlled trial of a group self management support program versus treatment as usual for anxiety disorders study protocol |
| topic | Anxiety disorders Self-management support Pragmatic trial Group intervention Web-based intervention Transdiagnostic |
| url | https://doi.org/10.1186/s12888-021-03675-4 |
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