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Clinical Trials/NCT04631939
NCT04631939
Recruiting
Not Applicable

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

Christina Andreou2 sites in 2 countries36 target enrollmentJune 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Schizophrenia and Related Disorders
Sponsor
Christina Andreou
Enrollment
36
Locations
2
Primary Endpoint
Change of delusion severity
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2021
End Date
December 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Christina Andreou
Responsible Party
Sponsor Investigator
Principal Investigator

Christina Andreou

Principal Investigator

University of Basel

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
  • Secondary psychotic disorders that are clearly induced by general medical conditions or substance use.
  • Previous participation in meta-cognitive training for psychosis

Outcomes

Primary Outcomes

Change of delusion severity

Time Frame: 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.

Secondary Outcomes

  • 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))

Study Sites (2)

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