Internet-Based Exposure Therapy Vs. Stress-Management Training for Worry: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 311
- 试验地点
- 2
- 主要终点
- Penn State Worry Questionnaire (PSWQ)
研究概览
简要总结
The purpose of this study is to examine if an internet-based exposure therapy is more effective in reducing excessive worry amongst patients who suffer from this problem than is internet-based stress management training.
详细描述
Trial Objectives: Primary objective is to investigate whether an Internet-based exposure therapy can reduce the degree of excessive worry to a significantly greater extent than Internet-based stress-management training. The secondary objective is to a) investigate the cost-effectiveness of this treatment b) to study if any variables could moderate/mediate the treatment outcome, c) and to investigate the importance of sudden gains for the treatment outcome
Trial Design: Randomized controlled trial with an active control and a waitlist control, who also will recieve treatment after the first group has finished.
Duration: Ten weeks
Primary Endpoint:
Difference in worry symptoms between the treatment groups at week 10. Long term follow-up is also investigated (baseline to 4-months after treatment completion and baseline to 12-months after treatment completion).
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
- None
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
- •Outpatients
- •≥ 18 years
- •Situated in Sweden
- •Informed consent
- •PSWQ score more than 56 points
排除标准
- •Substance dependence during the last six months
- •Post traumatic stress disorder, bipolar disorder or psychosis
- •Symptoms better explained by axis 2 diagnosis (e.g. autism or borderline personality disorder)
- •MADRS-S score above 25 points
- •Psychotropic medication changes within two months prior to treatment that could affect target symptoms.
- •Received exposure based CBT for pathological worry the last 2 years.
结局指标
主要结局
Penn State Worry Questionnaire (PSWQ)
时间窗: week 0, week 10 (weekly measurements), at 4 months follow up, 12 months follow up.
Change in worry from baseline to Week 10 and at 4- and 12 months after treatment has ended.
次要结局
- Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)(Week 0, Week 10, 4 and 12 months follow-up)
- Thought supression subscale of the Cognitive Avoidance Questionnaire (CAQ)(Week 0 - Week 10 (weekly measurements))
- The self-regulation subscale of the Multidimensional Assessment of Interoceptive Awareness(Week 0 - Week 10 (weekly measurements))
- Euroqol, EQ-5D(Week 0, Week 10, 4 and 12 months follow-up)
- Intolerance of uncertainty scale(Week 0, Week 10, at 4 and 12 months follow-up, and weekly during treatment)
- Brunnsviken Quality of Life Questionnaire (BBQ)(Week 0, Week 10, 4 and 12 months follow-up)
- Patient Health Questionnaire-2(Week 0 - Week 10 (weekly measurements))
- Adverse Events(Week 3, week 8, week 10, 4 and 12 months follow-up)
- Montgomery Åsberg Depression Rating Scale (MADRS-S)(Week 0, Week 10, 4 and 12 months follow-up)
- Cognitive Avoidance Questionnaire (CAQ)(Week 0, Week 10, at 4 and 12 months follow up and weekly during treatment)
研究者
Erik Andersson
PhD, Lic. psychologist
Karolinska Institutet