An interventional study of Metacognitive training game and Control games in Schizophrenia and Related Disorders, Psychotic Disorders and Delusions, sponsored by Christina Andreou. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2023-05-10.
Sponsored by Christina Andreou · Not applicable, Interventional, and Treatment
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.
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.
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
This study's planned enrollment of 36 is below the median of 71 across 2,944 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →This is the only study on the registry with Christina Andreou as lead sponsor.
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Exclusion Criteria:
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
The control intervention consists of a puzzles focused exclusively on dexterity and accuracy.
Device: Control games
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.
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.
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.
Time frame: Change from pre- to post-intervention (4 weeks)
Change of total PANSS Score
Total score on the Positive and Negative Syndrome Scale. Lower scores indicate better outcome.
Time frame: 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.
Time frame: 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'
Time frame: 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'
Time frame: Change from pre- to post-intervention (4 weeks)
Plan to share: Yes — All data we will be published on Zenodo under CC0 license.
Supporting information: Study protocol
Time frame: All data will be made openly accessible one year after the study end.
Access criteria: will be determined at a later time
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