Clinical trial NCT04631939: Metacognitive Training as a Serious Game
Official title: Metacognitive Training as a Serious Game: A New Approach for the Treatment of Delusions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia and Related Disorders
Psychotic Disorders
Delusions
Keywords: Psychotic disorders
Delusions
Metacognitive Training
Schizophrenia
Lead sponsor: University of Basel
Sponsor class: OTHER
First posted: 2020-11-17
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of delusion severity
timeFrame: Change from pre- to post-intervention (4 weeks)
Secondary outcomes:
measure: Change of total PANSS Score
timeFrame: Change from pre- to post-intervention (4 weeks)
measure: Change of delusional conviction
timeFrame: Change from pre- to post-intervention (4 weeks)
measure: Fish Task: change of number of draws to decision
timeFrame: Change from pre- to post-intervention (4 weeks)
measure: Fish Task: change of probability threshold to decision
timeFrame: Change from pre- to post-intervention (4 weeks)
Other outcomes:
Locations:
city: Lübeck
country: Germany
facility: Center for Integrative Psychiatry Lübeck
state: Schleswig-Holstein
city: Basel
country: Switzerland
facility: University Psychiatric Clinics Basel
state: Basel-Stadt
Study officials:
affiliation: University of Basel
name: Christina Andreou, PD Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Luebeck
name: Stefan Borgwardt, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: