Metacognitive Training as a Serious Game (Macu'ta)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Psychotic Disorders; Schizophrenia and Related Disorders; Delusions
• Intervention / Treatment: Device: Metacognitive training game; Device: Control games

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.

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christina Andreou, PD. Dr.; Phone Number: +41 61 325 8157; Email: christina.andreou@unibas.ch
• Study Contact Backup: Name: Renate de Bock, MSc; Phone Number: +41 61 325 8157; Email: renate.debock@unibas.ch

Study Locations

• Germany
  • Schleswig-Holstein
    • Lübeck, Schleswig-Holstein, Germany, 23538
      • Not yet recruiting
      • Center for Integrative Psychiatry Lübeck
      • Contact: Stefan Borgwardt, MD, PhD
• Switzerland
  • Basel-Stadt
    • Basel, Basel-Stadt, Switzerland, 4055
      • Recruiting
      • University Psychiatric Clinics Basel
      • Contact: Renate de Bock, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: study intervention; 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; 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.
Sham Comparator: control intervention; 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 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Christina Andreou
• Investigators: Principal Investigator: Christina Andreou, PD Dr., University of Basel; Principal Investigator: Stefan Borgwardt, Prof. Dr., University of Luebeck

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: November 5, 2020
• First Submitted That Met QC Criteria: November 10, 2020
• First Posted (Actual): November 17, 2020

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Schizophrenia; Psychotic disorders; Delusions; Metacognitive Training
• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Disease; Psychotic Disorders; Mental Disorders; Delusions
• Other Study ID Numbers: 2020-02291

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data we will be published on Zenodo under CC0 license.
• IPD Sharing Time Frame: All data will be made openly accessible one year after the study end.
• IPD Sharing Access Criteria: will be determined at a later time
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No