Fast Recovery From Anxiety-related Disorders: Brief-intensive CBT Versus Once-weekly CBT
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
- 试验地点
- 12
- 主要终点
- Area Under the health and disability Curve at 6 months
研究概览
简要总结
The goal of this clinical trial is to compare brief-intensive cognitive-behaviour therapy (CBT) with regular weekly CBT in people with anxiety-related disorders.
The main question to answer is: will brief-intensive CBT improve functioning (work, family, social) more and faster than does regular weekly CBT?
Participants will be asked to follow CBT treatment (20 sessions of 45 minutes in both conditions), and participate in 7 measurements with a total duration of 5 hours over 1 year.
Researchers will compare:
- Brief-intensive CBT: 16 sessions in 2 weeks + 4 follow-up sessions within 3 months
- Regular CBT with 20 weekly sessions in 6 months
详细描述
Rationale: Anxiety-related disorders (i.e., obsessive compulsive, health anxiety and trauma disorders) affect about 10% of the adults. Though clinically heterogeneous, transdiagnostic aspects are expected disasters, anxiety and avoidance. Profound impairments include work and family functioning. Many enter a vicious circle with comorbidity and further decline in quality of life. Hence, the impact on functioning is tremendous, with anxiety-related disorders rating highest on disability rankings in the age 15-64 years. Cognitive behavioral therapy (CBT) is the preferred and often only psychotherapy for these disorders. Because guidelines are based on weekly sessions, recovery takes half a year at least. Based on initial research findings, we expect faster recovery by providing CBT in a brief-intensive format (BI-CBT), with clear benefts for patients, families and society. Some institutions already provide BI-CBT. However, evidence to justify this or to further implement BI-CBT is insufficient.
Study design: a parallel-group randomised controlled multicenter intervention study.
Study population: Adults aged 18-65 yr old with an anxiety-related disorder (panic, agrophobia, social anxiety, generalised anxiety obsessions/compulsions, health anxiety and post-traumatic stress)
Intervention (if applicable): One group receives BI-CBT (16 sessions in 2 weeks + 4 follow up sessions) and the other group receives 20 weekly CBT sessions. Treatment in both conditions can be personalised by a focus on work or family functioning.
Main study parameters/endpoints: The main study parameter is the 'area under the curve' for 6-month health and disability. Also, 1 year efficacy (both on functioning and symptom-level), cost-effectiveness, and feasibility will be assessed. Potential predictors of treatment preference, efficacy and drop-out will be explored.
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
- Single (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
- •Age 18 years or older;
- •Reaching out for mental health care for one of the following disorders:
- •panic disorder, agoraphobia, generalised anxiety disorder, social anxiety disorder, posttraumatic stress disorder, obsessive-compulsive disorder, health anxiety disorder.
排除标准
- •Is in need of emergency mental health care
- •Has insufficient language skills in Dutch
- •Has evident cognitive limitations
- •Has had changes in the use of medication during the last 3 months.
研究组 & 干预措施
weekly CBT
20 weekly CBT sessions within 5 to 6 months. The CBT consists of exposure therapy.
干预措施: Cognitive behavioral therapy (CBT) (Behavioral)
Brief-Intensive CBT
16 sessions in 2 weeks + 4 follow up sessions. The CBT consists of 16 sessions exposure therapy, spread over 4 half-days in 2 weeks, + 4 sessions within 3 months.
干预措施: Cognitive behavioral therapy (CBT) (Behavioral)
结局指标
主要结局
Area Under the health and disability Curve at 6 months
时间窗: baseline, 2 weeks, 4 weeks, 2 months, 3 months, 6 months
The 'area under the curve' for health and disability is based on the 36-item self-report World Health Organisation Disability Assessment Schedule (WHODAS 2.0). The WHODAS 2.0 captures the level of functioning in six domains of life: Cognition, Mobility, Self-care, Getting along, Life activities, Participation. Possible total scores of the items across all domains range 0 - 100. Lower scores indicate less disability.
次要结局
- Area Under the health and disability Curve at 12 months(baseline, 2 weeks, 4 weeks, 2 months, 3 months, 6 months, 12 months)
- Change from baseline in severity of anxiety symptoms at post-treatment(baseline and 3 or 6 months)
- Change from baseline in severity of anxiety symptoms at 3 months(baseline and 3 months)
- Change from baseline in severity of depressive symptoms at 3 months(baseline and 3 months)
- Change from baseline in severity of anxiety symptoms at 12 months(baseline and 12 months)
- Change from baseline in severity of depressive symptoms at post-treatment(baseline and 3 or 6 months)
- Remission rates from anxiety-related disorder at 12 months(12 months)
- Change from baseline in severity of depressive symptoms at 12 months(baseline and 12 months)
- Remission rates from anxiety-related disorder at post-treatment(3 or 6 months)
- New-onset anxiety-related or depressive disorder post-treatment(baseline, 3 or 6 months)
- New-onset anxiety-related or depressive disorder at 12 months(12 months)
- Productivity costs over 12 months(3months, 6months, 12 months)
- Medical costs over 12 months(3months, 6months, 12 months)
- Change from baseline in health-related quality of life over 12 months(baseline, 2 weeks, 4 weeks, 2 months, 3 months, 6 months, 12 months)
- Drop-out rates at post-treatment(3 or 6 months)
- Patient satisfaction at post-treatment(3 or 6 months)
- Negative effects of psychotherapy(3 or 6 months)
研究者
Adrie Seldenrijk
Principal investigator
Amsterdam UMC, location VUmc