Metacognitive Training as a Serious Game

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Metacognitive Training as a Serious Game: A New Approach for the Treatment of Delusions

Conditions
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Schizophrenia and Related Disorders, Psychotic Disorders, Delusions

Intervention / Treatment
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* Device: Metacognitive training game
* Device: Control games


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged between 18 and 40 diagnosis of a psychotic disorder and current delusions or a history of delusions Exclusion Criteria: Language skills insufficient for assessments IQ < 70 Secondary psychotic disorders that are clearly induced by general medical conditions or substance use. Previous participation in meta-cognitive training for psychosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study intervention<br>The intervention consists of a puzzle adventure game, in which players have to explore the fantasy world Macu'ta. The puzzles are based on Metacognitive Training for Psychosis (MCT), an intervention using playful, entertaining exercises to increase awareness of reasoning biases in patients and 'sow the seeds of doubt' through corrective ('aha!') experiences. The tasks will address reasoning biases associated with the emergence and maintenance of delusions. | Device: Metacognitive training game<br>* In the fantasy world Macu'ta, players explore the world by walking around with an avatar in order to find the puzzles and proceed in the game. The intervention consists of 4 different puzzles. Unbeknownst to the player, the first pieces of evidence of each puzzle are often misleading, i.e. indicate the wrong solution, such that hasty decisions are punished. Players receive immediate feedback and are shown the correct response after submitting their solution, as well as explicit cues that educate them on the value of making adequately informed decisions. The order of the puzzles is fixed for each player, but different per session.<br>|
| Sham Comparator: control intervention<br>The control intervention consists of a puzzles focused exclusively on dexterity and accuracy. | Device: Control games<br>* In the fantasy world Macu'ta, players explore the world by walking around with an avatar in order to find the puzzles and proceed in the game. The control intervention consists of 4 different puzzle games requiring exclusively dexterity and accuracy (i.e., not including any metacognitive elements). The order of the puzzles is fixed for each player, but different per session.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of delusion severity | Item P1 of the Positive and Negative Syndrome Scale (PANSS). Min score = 1, max score = 7, where lower scores indicate better outcome. | Change from pre- to post-intervention (4 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of total PANSS Score | Total score on the Positive and Negative Syndrome Scale. Lower scores indicate better outcome. | Change from pre- to post-intervention (4 weeks) | 
| Change of delusional conviction | Total score on the Psychotic Symptom Rating Scales, delusion part (PSYRATS). Lower scores indicate better outcome. | Change from pre- to post-intervention (4 weeks) | 
| Fish Task: change of number of draws to decision | Number of draws to decision, assessed with the 'Fish task' | Change from pre- to post-intervention (4 weeks) | 
| Fish Task: change of probability threshold to decision | Probability threshold to decision, assessed with the 'Fish task' | Change from pre- to post-intervention (4 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychotic disorders, Delusions, Metacognitive Training, Schizophrenia