Metacognitive Training as a Serious Game

NCT ID: NCT04631939

Last Updated: 2023-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Schizophrenia and Related Disorders Psychotic Disorders Delusions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Metacognitive training game

Intervention Type 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.

control intervention

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

Group Type SHAM_COMPARATOR

Control games

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Christina Andreou

OTHER

Sponsor Role lead

Responsible Party

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Christina Andreou

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Christina Andreou, PD Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Basel

Stefan Borgwardt, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Luebeck

Locations

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Center for Integrative Psychiatry Lübeck

Lübeck, Schleswig-Holstein, Germany

Site Status NOT_YET_RECRUITING

University Psychiatric Clinics Basel

Basel, Canton of Basel-City, Switzerland

Site Status RECRUITING

Countries

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Germany Switzerland

Central Contacts

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Christina Andreou, PD. Dr.

Role: CONTACT

+41 61 325 8157

Renate de Bock, MSc

Role: CONTACT

+41 61 325 8157

Facility Contacts

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Stefan Borgwardt, MD, PhD

Role: primary

Renate de Bock, MSc

Role: primary

Other Identifiers

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2020-02291

Identifier Type: -

Identifier Source: org_study_id

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