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
- 1
- 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.
研究组 & 干预措施
Internet-based exposure therapy
The internet-based exposure therapy (I-ET) group receives a ten-week Internet-based CBT treatment, which is an extended version of the self-help book "Sluta älta och grubbla med kognitiv beteendeterapi" (How to quit worrying and ruminating with Cognitive behavior therapy) by licensed psychologist Olle Wadström (2007). The main focus of the book is to expose to the frightening word/image and refrain from using neutralizing thoughts. This is supposed to lead to the extinction of upsetting words/images.
干预措施: Internet-based exposure therapy (I-ET) (Behavioral)
Internet-based stress management therapy
The I-SMT group receives a ten-week Internet-based CBT treatment focused on stress and how to manage stressful situations. This protocol is based on current evidence based recommendations for worry and has shown to be effective when delivered via the internet for irritable bowel syndrome and hypochondric worries.
干预措施: Internet-based stress management therapy (Behavioral)
Waitlist
When the active treatment groups have finished treatment (W11), the WL group will be able to start active treatment and be assessed at post-treatment, and 4, 12 months later using the same questionnaires as the treatment group. The participants will be able to choose which treatment they receive i.e. no randomization.
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