Metacognitive Training as a Serious Game: A New Approach for the Treatment of Delusions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 4
- 主要终点
- Change of delusion severity
研究概览
简要总结
The project aims to evaluate the efficacy of a therapeutic video game that incorporates elements from metacognitive training on delusions and jumping-to-conclusions in patients with psychotic disorders.
详细描述
The study is an international, multicenter study and is being conducted in Switzerland (University of Basel) as well as in Germany (University of Lübeck). A total of 36 participants will be included. The estimated duration of the study is 15 months. All participants play a video game from the genre "Third Person Adventure". A character is navigated through a fantasy world using a keyboard and mouse. In the fantasy world, "stations" in the form of glowing gems are sought where players have to solve different tasks.
Participants are randomized to receive either the therapeutic video game with metacognitive training content or another video game with attention and memory tasks ("control intervention"). The control intervention does not include metacognitive tasks. Metacognitive training is an approach for the treatment of psychotic disorders, particularly delusions. The focus of metacognitive training is on thought distortions (so-called "cognitive biases") that are more pronounced in people with psychosis. The control intervention includes easily understandable, playful tasks. The intervention will take 4 appointments within 2 weeks.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged between 18 and 40
- •diagnosis of a psychotic disorder and current delusions or a history of delusions
排除标准
- •Language skills insufficient for assessments
- •Secondary psychotic disorders that are clearly induced by general medical conditions or substance use.
- •Previous participation in meta-cognitive training for psychosis
结局指标
主要结局
Change of delusion severity
时间窗: Change from pre- to post-intervention (4 weeks)
Item P1 of the Positive and Negative Syndrome Scale (PANSS). Min score = 1, max score = 7, where lower scores indicate better outcome.
次要结局
- Change of total PANSS Score(Change from pre- to post-intervention (4 weeks))
- Change of delusional conviction(Change from pre- to post-intervention (4 weeks))
- Fish Task: change of probability threshold to decision(Change from pre- to post-intervention (4 weeks))
- Fish Task: change of number of draws to decision(Change from pre- to post-intervention (4 weeks))
研究者
Christina Andreou
Principal Investigator
University of Basel