Negative Meta-cognitions as a Causal Factor to Worry: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 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 investigate if an internet-based metacognitive therapy reduces negative metacognitions and if reductions negative metacognitions mediates reductions in worry.
详细描述
The aim is primary mechanistic i.e. we want to investigate if a clear change in negative metacognitions in one group (internet-based metacognitive therapy; I-MCT) relative to another (waiting list) mediates subsequent reductions in worry.
Our hypotheses are the following:
- I-MCT reduces both negative metacognitions (Beliefs about uncontrollability and danger of worry) and worry from baseline to week 10,
- reductions in negative metacognitions will significantly mediate subsequent reductions in worry.
Additionally we hypothesize that patients who score low at baseline in negative metacognitions will not show this process pattern i.e. 3. patients who score low at baseline in negative metacognitions will benefit less from treatment (moderator hypothesis)
and consequently 4. will not show the same mediation response as stipulated in hypothesis 2 (moderated mediator hypothesis).
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 metacognitive therapy for pathological worry the last 2 years.
结局指标
主要结局
Penn State Worry Questionnaire (PSWQ)
时间窗: Weekly measurements week 0-10, 6 and 12 months follow-up
Change in worry, weekly measurements, and at 6 and 12 months after treatment has ended.
Negative beliefs about uncontrollability of thoughts and danger in the Meta Cognitions Questionnaire (MCQ-30)
时间窗: Weekly measurements week 0-10, 6 and 12 months follow-up
Change in Negative beliefs about uncontrollability of thoughts and danger, weekly measurements, and at 6 and 12 months after treatment has ended.
次要结局
- Euroqol, EQ-5D(Week 0, Week 10, 6 and 12 months follow-up)
- Cognitive Avoidance Questionnaire (CAQ)(Week 0, Week 10, 6 and 12 months follow-up)
- Meta Cognitions Questionnaire (MCQ-30)(Weekly measurements, 6 and 12 months follow-up)
- Patient health questionnaire 2 items (PHQ-2)(Week 0 - Week 10 (weekly measurements), 6 and 12 months follow-up)
- Montgomery Åsberg Depression Rating Scale (MADRS-S)(Week 0, Week 10, 6 and 12 months follow-up)
- Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P) [Time Frame: Week 0, Week 10, 6 and 12 months follow-up](Week 0, Week 10, 6 and 12 months follow-up)
- Adverse Events(Week 10, 6 and 12 months follow-up)
- Contrast avoidance questionnaire(Week 0, Week 10, 6 and 12 months follow-up)
研究者
Erik Andersson
PhD, Lic. psychologist
Karolinska Institutet