Centre de recherche du Centre hospitalier universitaire de Sherbrooke (CRCHUS), Department of Family Medicine and Emergency Medicine, Faculty of Medicine and Health Sciences, Université de Sherbrooke, 3001, 12th Avenue North, Sherbrooke, QC, J1H 5N4, Canada.
École de psychologie, Pavillon Félix-Antoine-Savard, 2325, rue des Bibliothèques, Université Laval, Québec, QC, G1V 0A6, Canada.
BMC Psychiatry. 2018 Oct 3;18(1):320. doi: 10.1186/s12888-018-1898-1.
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.
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.
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.
ClinicalTrials.gov: NCT02811458 .
焦虑障碍是社区环境中最常见的精神障碍，它们与显著的心理痛苦、功能和社会障碍有关。虽然认知行为疗法（CBT）是治疗焦虑障碍最有效的心理治疗方法，但由于各种障碍，CBT 在初级保健中的广泛实施受到阻碍。跨诊断组认知行为疗法（tCBT）侧重于不同焦虑障碍共有的认知和行为过程以及干预策略，可能是传统 CBT 的一种有前途的替代方法。本研究旨在检验作为初级精神卫生保健中常规治疗（TAU）的补充，焦虑障碍跨诊断组 CBT 方案的有效性。
方法/设计：该试验是一项多中心实用随机对照试验，采用治疗前、治疗后和随访 4、8 和 12 个月的设计。治疗组和对照组：a）tCBT（遵循手册化治疗方案的 12 周每周 2 小时小组治疗）；b）TAU 治疗焦虑障碍。纳入标准包括符合 DSM-5 标准的原发性惊恐障碍、广场恐怖症、社交焦虑障碍和/或广泛性焦虑障碍。患者在加拿大魁北克省的三个地区招募。主要结局测量指标是自我报告的贝克焦虑量表和临床医生管理的 DSM-5 焦虑及相关障碍访谈表（ADIS-5）；次要结局测量指标包括基于 ADIS-5 的治疗反应者状态，以及特定焦虑和抑郁症状、生活质量、功能和服务利用情况的自我报告量表。
意向治疗分析。混合效应回归模型将用于分析干预的纵向效果，考虑到组内和组间的变化。
该研究对 tCBT 在真实世界中的严格评估将为决策者、医疗保健管理人员、临床医生和患者提供有关干预有效性的宝贵信息。tCBT 方案在初级保健中的广泛实施可能会为目前未获得循证心理治疗的大量焦虑障碍患者带来更好的效果、效率、可及性和公平性。
ClinicalTrials.gov：NCT02811458。
