Internet-based Exposure Therapy for Excessive Worry: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 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 effective in reducing excessive worry amongst patients who suffer from this problem.
详细描述
Trial Objectives: Primary objective is to investigate whether an Internet-based exposure therapy can effectively reduce the degree of excessive worry. The secondary objective is to a) investigate whether imagery based exposure is more effective than verbal exposure. b) investigate the cost-effectiveness of this treatment and c) to study if any variables could moderate/mediate the treatment outcome, such as metacognitions, degree of rumination or degree of depression.
Trial Design: Randomized controlled trial with waitlist control, who also will recieve treatment after the first group has finished.
Duration: Ten weeks
Primary Endpoint: Change in worry symptoms from baseline to Week 10. Long term follow-up is also investigated (baseline to 4-months after treatment completion and baseline to 12-months after treatment completion).
Efficacy Parameters: Penn State Worry Questionnaire (PSWQ)
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
- •Penn State Worry Questionnaire 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 Cognitive behavior therapy (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, Long term follow-up at 4-, and 12-months after treatment has ended
Change in worry from baseline to Week 10, and at 4- and 12 months after treatment has ended.
次要结局
- Spontaneous Use of Imagery Scale (SUIS)(Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended)
- Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S)(Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended)
- Cognitive Avoidance Questionnaire (CAQ)(Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended)
- Meta Cognitions Questionnaire (MCQ-30)(Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended)
- Euroqol (EQ-5D)(Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended)
- Hospital anxiety and depression scale (HADS)(Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended)
- Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)(Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended)
- Intolerance of Uncertainty Scale (IUS)(Week 0, Week 10, long term follow-up at 4- and 12- months after treatment has ended)
研究者
Erik Andersson
PhD, psychologist
Karolinska Institutet