A pragmatic randomized controlled trial of group transdiagnostic cognitive-behaviour therapy for anxiety disorders in primary care: study protocol

Abstract Background Anxiety disorders are the most common mental disorders in community settings, and they are associated with significant psychological distress, functional and social impairment. While cognitive behaviour therapy (CBT) is the most consistently efficacious psychological treatment fo...

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Main Authors: Pasquale Roberge, Martin D Provencher, Patrick Gosselin, Helen-Maria Vasiliadis, Isabelle Gaboury, Annie Benoit, Martin M Antony, Nils Chaillet, Janie Houle, Catherine Hudon, Peter J Norton
Format: Article
Language:English
Published: BMC 2018-10-01
Series:BMC Psychiatry
Subjects:
Online Access:http://link.springer.com/article/10.1186/s12888-018-1898-1
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author Pasquale Roberge
Martin D Provencher
Patrick Gosselin
Helen-Maria Vasiliadis
Isabelle Gaboury
Annie Benoit
Martin M Antony
Nils Chaillet
Janie Houle
Catherine Hudon
Peter J Norton
author_facet Pasquale Roberge
Martin D Provencher
Patrick Gosselin
Helen-Maria Vasiliadis
Isabelle Gaboury
Annie Benoit
Martin M Antony
Nils Chaillet
Janie Houle
Catherine Hudon
Peter J Norton
author_sort Pasquale Roberge
collection DOAJ
description Abstract Background Anxiety disorders are the most common mental disorders in community settings, and they are associated with significant psychological distress, functional and social impairment. While cognitive behaviour therapy (CBT) is the most consistently efficacious psychological treatment for anxiety disorders, barriers preclude widespread implementation of CBT in primary care. Transdiagnostic group CBT (tCBT) focuses on cognitive and behavioural processes and intervention strategies common to different anxiety disorders, and could be a promising alternative to conventional CBT. This study aims to examine the effectiveness of a transdiagnostic group CBT for anxiety disorders program as a complement to treatment-as-usual (TAU) in primary mental health care. Methods/Design The trial is a multicentre pragmatic randomized controlled trial with a pre-treatment, post-treatment, and follow-up at 4, 8 and 12-months design. Treatment and control groups . a) tCBT (12 weekly 2-h group sessions following a manualized treatment protocol); b) TAU for anxiety disorders. Inclusion criteria comprise meeting DSM-5 criteria for primary Panic Disorder, Agoraphobia, Social Anxiety Disorder and/or Generalized Anxiety Disorder. Patients are recruited in three regions in the province of Quebec, Canada. The primary outcome measures are the self-reported Beck Anxiety Inventory and the clinician-administered Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-5); secondary outcome measures include treatment responder status based on the ADIS-5, and self-reported instruments for specific anxiety and depression symptoms, quality of life, functioning, and service utilisation. Statistical analysis: Intention-to-treat analysis. A mixed effects regression model will be used to account for between- and within-subject variations in the analysis of the longitudinal effects of the intervention. Discussion This rigorous evaluation of tCBT in the real world will provide invaluable information to decision makers, health care managers, clinicians and patients regarding the effectiveness of the intervention. Widespread implementation of tCBT protocols in primary care could lead to better effectiveness, efficiency, access and equity for the large number of patients suffering from anxiety disorders that are currently not obtaining evidence-based psychotherapy. Trial registration ClinicalTrials.gov: NCT02811458.
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spelling doaj.art-2e66b19421b24d1ab73dbe409338e1622022-12-21T19:27:14ZengBMCBMC Psychiatry1471-244X2018-10-0118111410.1186/s12888-018-1898-1A pragmatic randomized controlled trial of group transdiagnostic cognitive-behaviour therapy for anxiety disorders in primary care: study protocolPasquale Roberge0Martin D Provencher1Patrick Gosselin2Helen-Maria Vasiliadis3Isabelle Gaboury4Annie Benoit5Martin M Antony6Nils Chaillet7Janie Houle8Catherine Hudon9Peter J Norton10Centre de recherche du Centre hospitalier universitaire de Sherbrooke (CRCHUS), Department of Family Medicine and Emergency Medicine, Faculty of Medicine and Health Sciences, Université de SherbrookeÉcole de psychologie, Pavillon Félix-Antoine-Savard, 2325, rue des Bibliothèques, Université LavalInstitut universitaire de première ligne en santé et services sociaux (CIUSSS de l’Estrie- CHUS), Department of Psychology, Université de SherbrookeDepartment of Community Health Sciences, Université de Sherbrooke, Centre de recherche Hôpital Charles LeMoyneCentre de recherche du Centre hospitalier universitaire de Sherbrooke (CRCHUS), Department of Family Medicine and Emergency Medicine, Faculty of Medicine and Health Sciences, Université de SherbrookeCentre de recherche du Centre hospitalier universitaire de Sherbrooke (CRCHUS), Department of Family Medicine and Emergency Medicine, Faculty of Medicine and Health Sciences, Université de SherbrookeDepartment of Psychology, Ryerson UniversityDepartment of Obstetrics, Gynecology, and Reproduction, Université LavalDepartment of Psychology, Université du Québec à MontréalCentre de recherche du Centre hospitalier universitaire de Sherbrooke (CRCHUS), Department of Family Medicine and Emergency Medicine, Faculty of Medicine and Health Sciences, Université de SherbrookeMonash Institute of Cognitive and Clinical Neurosciences, School of Psychological Sciences, Monash UniversityAbstract Background Anxiety disorders are the most common mental disorders in community settings, and they are associated with significant psychological distress, functional and social impairment. While cognitive behaviour therapy (CBT) is the most consistently efficacious psychological treatment for anxiety disorders, barriers preclude widespread implementation of CBT in primary care. Transdiagnostic group CBT (tCBT) focuses on cognitive and behavioural processes and intervention strategies common to different anxiety disorders, and could be a promising alternative to conventional CBT. This study aims to examine the effectiveness of a transdiagnostic group CBT for anxiety disorders program as a complement to treatment-as-usual (TAU) in primary mental health care. Methods/Design The trial is a multicentre pragmatic randomized controlled trial with a pre-treatment, post-treatment, and follow-up at 4, 8 and 12-months design. Treatment and control groups . a) tCBT (12 weekly 2-h group sessions following a manualized treatment protocol); b) TAU for anxiety disorders. Inclusion criteria comprise meeting DSM-5 criteria for primary Panic Disorder, Agoraphobia, Social Anxiety Disorder and/or Generalized Anxiety Disorder. Patients are recruited in three regions in the province of Quebec, Canada. The primary outcome measures are the self-reported Beck Anxiety Inventory and the clinician-administered Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-5); secondary outcome measures include treatment responder status based on the ADIS-5, and self-reported instruments for specific anxiety and depression symptoms, quality of life, functioning, and service utilisation. Statistical analysis: Intention-to-treat analysis. A mixed effects regression model will be used to account for between- and within-subject variations in the analysis of the longitudinal effects of the intervention. Discussion This rigorous evaluation of tCBT in the real world will provide invaluable information to decision makers, health care managers, clinicians and patients regarding the effectiveness of the intervention. Widespread implementation of tCBT protocols in primary care could lead to better effectiveness, efficiency, access and equity for the large number of patients suffering from anxiety disorders that are currently not obtaining evidence-based psychotherapy. Trial registration ClinicalTrials.gov: NCT02811458.http://link.springer.com/article/10.1186/s12888-018-1898-1Anxiety disordersCognitive behaviour therapyPragmatic trialGroup treatmentPrimary careAccess to psychotherapy
spellingShingle Pasquale Roberge
Martin D Provencher
Patrick Gosselin
Helen-Maria Vasiliadis
Isabelle Gaboury
Annie Benoit
Martin M Antony
Nils Chaillet
Janie Houle
Catherine Hudon
Peter J Norton
A pragmatic randomized controlled trial of group transdiagnostic cognitive-behaviour therapy for anxiety disorders in primary care: study protocol
BMC Psychiatry
Anxiety disorders
Cognitive behaviour therapy
Pragmatic trial
Group treatment
Primary care
Access to psychotherapy
title A pragmatic randomized controlled trial of group transdiagnostic cognitive-behaviour therapy for anxiety disorders in primary care: study protocol
title_full A pragmatic randomized controlled trial of group transdiagnostic cognitive-behaviour therapy for anxiety disorders in primary care: study protocol
title_fullStr A pragmatic randomized controlled trial of group transdiagnostic cognitive-behaviour therapy for anxiety disorders in primary care: study protocol
title_full_unstemmed A pragmatic randomized controlled trial of group transdiagnostic cognitive-behaviour therapy for anxiety disorders in primary care: study protocol
title_short A pragmatic randomized controlled trial of group transdiagnostic cognitive-behaviour therapy for anxiety disorders in primary care: study protocol
title_sort pragmatic randomized controlled trial of group transdiagnostic cognitive behaviour therapy for anxiety disorders in primary care study protocol
topic Anxiety disorders
Cognitive behaviour therapy
Pragmatic trial
Group treatment
Primary care
Access to psychotherapy
url http://link.springer.com/article/10.1186/s12888-018-1898-1
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