A Pragmatic Randomized Controlled Trial of a Group Self-management Support Program Versus Treatment-as-usual for Anxiety Disorders
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 414
- 试验地点
- 2
- 主要终点
- Change in Beck Anxiety Inventory (BAI)
研究概览
简要总结
Background. Self-management support is a complementary approach to treatment that aims to educate participants on the nature of anxiety and to improve their strategies to manage symptoms and well-being, thus presenting the potential to enhance recovery, improve outcomes, reduce recurrence rates and lower health care costs. There is limited evidence to support the effectiveness of group self-management support for anxiety disorders in community-based care.
Objectives. This study aims at examining the effectiveness of a virtual group self-management support program (SMS) for anxiety disorders as an add-on to treatment-as-usual (TAU) in community-based care settings. We will also assess the incremental cost/effectiveness ratio and the implementability of the intervention.
Methods. The trial is a pragmatic randomized controlled trial with a pre-treatment, post-treatment (4-month post-randomization), and follow-ups at 8, 12 and 24-months. Intervention. The experimental condition will consist of a 10-week SMS program for anxiety disorders in addition to TAU. The control condition will receive TAU without restrictions for anxiety disorders. Inclusion criteria will comprise being 18 years old or older, French-speaking, and presenting symptoms of anxiety disorders based on self-reported validated assessment scales. Patients will be recruited in the province of Quebec (Canada). Outcome measures: The primary outcome measure is the Beck Anxiety Inventory (BAI). The secondary outcome measures include self-reported instruments for anxiety and depressive symptoms, recovery, self-management, quality of life, 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.
Expected outcomes. The rigorous evaluation of the SMS intervention in the real world will provide information to decision makers, health care managers, clinicians and patients regarding the added value of group SMS for patients with anxiety disorders. Widespread implementation of this intervention could lead to more efficient mental health care services, to better long-term outcomes and to a significant reduction in the extensive social and economic burden of anxiety disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) aged 18 and over,
- •(2) fluent in spoken and written French,
- •(3) presence of symptoms of anxiety disorders based on self-reported validated assessment scales and semi-structured assessment interview,
- •(4) access to a computer or tablet connected to the internet with microphone and video camera
排除标准
- •(1) previous enrolment in the SMS intervention provided by Relief
- •(2) active suicidal intentions,
- •(3) severe depressive symptoms,
- •(4) active substance-related and addictive disorder,
- •(5) cognitive impairment
结局指标
主要结局
Change in Beck Anxiety Inventory (BAI)
时间窗: Baseline and post-treatment (4-month post-randomization)
次要结局
- Change in Recovery Assessment Scale - Revised(Baseline, post-treatment,12-month and 24-month post-randomization follow-ups)
- Change in Mental Health Self-Management Questionnaire(Baseline, post-treatment,12-month and 24-month post-randomization follow-ups)
- Change in Beck Anxiety Inventory(Baseline, post-treatment, and 8-month, 12-month, 24-month post-randomization follow-ups)
- Change in Generalised Anxiety Disorder-7(Baseline, post-treatment, and 8-month, 12-month, 24-month post-randomization follow-ups)
- Change in Patient Health Questionnaire-9(Baseline, post-treatment,12-month and 24-month post-randomization follow-ups)
- Change in Administrative databases records(Starting 12 months prior to participant enrolment up to the 24-month post-randomization follow-up)
- Change in Assessment of Quality of Life - 6 Dimensions(Baseline, post-treatment, and 8-month, 12-month, 24-month post-randomization follow-ups)
- Change in Health care use and indirect costs(Baseline, post-treatment, and 8-month, 12-month, 24-month post-randomization follow-ups)