Metacognitive Training as a Serious Game

NCT04631939 | Unknown

• 1 other identifier: 2020-02291
• Study Type: interventional
• Target: 36
• Locations: 2 countries
• Sites: 2

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.

Conditions

Schizophrenia and Related Disorders; Psychotic Disorders; Delusions

Keywords

Psychotic disorders; Delusions; Metacognitive Training; Schizophrenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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 number of draws to decision

  Change from pre- to post-intervention (4 weeks)

• Fish Task: change of probability threshold to decision

  Change from pre- to post-intervention (4 weeks)

Study Arms (2)

study intervention

EXPERIMENTAL

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

control intervention

SHAM COMPARATOR

The control intervention consists of a puzzles focused exclusively on dexterity and accuracy.

Device: Control games

Interventions

Metacognitive training game DEVICE

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.

study intervention

Control games DEVICE

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.

control intervention

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• aged between 18 and 40
• diagnosis of a psychotic disorder and current delusions or a history of delusions

You may not qualify if:

• 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

Sponsors & Collaborators

• Christina Andreou: lead

Study Sites (2)

Center for Integrative Psychiatry Lübeck

Lübeck, Schleswig-Holstein, 23538, Germany

NOT YET RECRUITING

University Psychiatric Clinics Basel

Basel, Canton of Basel-City, 4055, Switzerland

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Delusions

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Christina Andreou, PD Dr.

  University of Basel

  PRINCIPAL INVESTIGATOR

• Stefan Borgwardt, Prof. Dr.

  University of Luebeck

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Andreou, PD. Dr.

CONTACT

+41 61 325 8157; christina.andreou@unibas.ch

Renate de Bock, MSc

CONTACT

+41 61 325 8157; renate.debock@unibas.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 17, 2020
• Study Start: June 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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

Locations

CH (1); DE (1)