search
Back to results

Metacognitive Training as a Serious Game (Macu'ta)

Primary Purpose

Schizophrenia and Related Disorders, Psychotic Disorders, Delusions

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Metacognitive training game
Control games
Sponsored by
Christina Andreou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia and Related Disorders focused on measuring Psychotic disorders, Delusions, Metacognitive Training, Schizophrenia

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Center for Integrative Psychiatry Lübeck
  • University Psychiatric Clinics BaselRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

study intervention

control intervention

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change of total PANSS Score
Total score on the Positive and Negative Syndrome Scale. Lower scores indicate better outcome.
Change of delusional conviction
Total score on the Psychotic Symptom Rating Scales, delusion part (PSYRATS). Lower scores indicate better outcome.
Fish Task: change of number of draws to decision
Number of draws to decision, assessed with the 'Fish task'
Fish Task: change of probability threshold to decision
Probability threshold to decision, assessed with the 'Fish task'

Full Information

First Posted
November 5, 2020
Last Updated
May 8, 2023
Sponsor
Christina Andreou
search

1. Study Identification

Unique Protocol Identification Number
NCT04631939
Brief Title
Metacognitive Training as a Serious Game
Acronym
Macu'ta
Official Title
Metacognitive Training as a Serious Game: A New Approach for the Treatment of Delusions
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Christina Andreou

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia and Related Disorders, Psychotic Disorders, Delusions
Keywords
Psychotic disorders, Delusions, Metacognitive Training, Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
study intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
control intervention
Arm Type
Sham Comparator
Arm Description
The control intervention consists of a puzzles focused exclusively on dexterity and accuracy.
Intervention Type
Device
Intervention Name(s)
Metacognitive training game
Intervention Description
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
Intervention Name(s)
Control games
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of delusion severity
Description
Item P1 of the Positive and Negative Syndrome Scale (PANSS). Min score = 1, max score = 7, where lower scores indicate better outcome.
Time Frame
Change from pre- to post-intervention (4 weeks)
Secondary Outcome Measure Information:
Title
Change of total PANSS Score
Description
Total score on the Positive and Negative Syndrome Scale. Lower scores indicate better outcome.
Time Frame
Change from pre- to post-intervention (4 weeks)
Title
Change of delusional conviction
Description
Total score on the Psychotic Symptom Rating Scales, delusion part (PSYRATS). Lower scores indicate better outcome.
Time Frame
Change from pre- to post-intervention (4 weeks)
Title
Fish Task: change of number of draws to decision
Description
Number of draws to decision, assessed with the 'Fish task'
Time Frame
Change from pre- to post-intervention (4 weeks)
Title
Fish Task: change of probability threshold to decision
Description
Probability threshold to decision, assessed with the 'Fish task'
Time Frame
Change from pre- to post-intervention (4 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christina Andreou, PD. Dr.
Phone
+41 61 325 8157
Email
christina.andreou@unibas.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Renate de Bock, MSc
Phone
+41 61 325 8157
Email
renate.debock@unibas.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Andreou, PD Dr.
Organizational Affiliation
University of Basel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stefan Borgwardt, Prof. Dr.
Organizational Affiliation
University of Luebeck
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Integrative Psychiatry Lübeck
City
Lübeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Borgwardt, MD, PhD
Facility Name
University Psychiatric Clinics Basel
City
Basel
State/Province
Basel-Stadt
ZIP/Postal Code
4055
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renate de Bock, MSc

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Metacognitive Training as a Serious Game

We'll reach out to this number within 24 hrs