Metacognitive Training as a Serious Game

Psychotic Disorders Clinical Trial

— Macu'ta  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04631939
• Other study ID #: 2020-02291
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: December 2023

Study information

• Verified date: May 2023
• Source: University of Basel
• Contact: Christina Andreou, PD. Dr.
• Phone: +41 61 325 8157
• Email: christina.andreou[@]unibas.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Delusions
• Disease
• Mental Disorders
• Psychotic Disorders
• Schizophrenia
• Schizophrenia and Related Disorders

Intervention

Device:
• Metacognitive training game
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.
• 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 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.

Locations

Country	Name	City	State
Germany	Center for Integrative Psychiatry Lübeck	Lübeck	Schleswig-Holstein
Switzerland	University Psychiatric Clinics Basel	Basel	Basel-Stadt

Sponsors (1)

Lead Sponsor	Collaborator
Christina Andreou

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)