Schizophrenia and Related DisordersMacu'taNCT04631939
Metacognitive Training as a Serious Game
A study testing Metacognitive training game in people with Schizophrenia and Related Disorders and Psychotic Disorders, run by Christina Andreou at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Schizophrenia and Related Disorders, Psychotic Disorders, Delusions
- What is being tested?
- Metacognitive training game
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jun 2021to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- aged between 18 and 40
- diagnosis of a psychotic disorder and current delusions or a history of delusions
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 site, 1 recruiting
- Not yet recruiting
Center for Integrative Psychiatry Lübeck
Lübeck, Schleswig-Holstein, 23538
Stefan Borgwardt, MD, PhD
Switzerland1 site, 1 recruiting
- Recruiting
University Psychiatric Clinics Basel
Basel, Canton of Basel-City, 4055
Renate de Bock, MSc
About this study
Official title: 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.
Read the 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.
- Being tested
- Metacognitive training game, Control games
- Keywords
- Psychotic disorders, Delusions, Metacognitive Training, Schizophrenia
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Delusions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metacognitive training gameDevice
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 gamesDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Metacognitive training game |
| control intervention | Sham comparator | The control intervention consists of a puzzles focused exclusively on dexterity and accuracy. Receives: Device: Control games |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from pre- to post-intervention (4 weeks)
Secondary outcomes (4)
Change of total PANSS Score
Total score on the Positive and Negative Syndrome Scale. Lower scores indicate better outcome.
Measured: 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.
Measured: 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'
Measured: 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'
Measured: Change from pre- to post-intervention (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start1 Jun 2021
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia and Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christina Andreou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christina Andreou, University of Basel
- Investigators
- Christina Andreou, PD Dr., Principal investigator, University of BaselStefan Borgwardt, Prof. Dr., Principal investigator, University of Luebeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04631939
- Sponsor's protocol ID
- 2020-02291
- Acronym
- Macu'ta
- Status last verified
- May 2023
- First submitted
- 5 Nov 2020
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data we will be published on Zenodo under CC0 license.
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metacognitive Training as a Serious Game: A New Approach for the Treatment of Delusions
- ClinicalTrials.gov ID
- NCT04631939
- Acronym / sponsor ID
- Macu'ta / 2020-02291
- Keywords
- Psychotic disorders, Delusions, Metacognitive Training, Schizophrenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Christina AndreouUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 17 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study intervention | Experimental | Device: Metacognitive training gameThe 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. |
| control intervention | Sham comparator | Device: Control gamesThe control intervention consists of a puzzles focused exclusively on dexterity and accuracy. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- aged between 18 and 40
- diagnosis of a psychotic disorder and current delusions or a history of delusions
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metacognitive training gameIn 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. | Device | study intervention |
| Control gamesIn 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. | Device | control intervention |
Primary outcome
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.
4 secondary outcomes
Change of total PANSS Score
Time frame: Change from pre- to post-intervention (4 weeks)
Change of delusional conviction
Time frame: Change from pre- to post-intervention (4 weeks)
Fish Task: change of number of draws to decision
Time frame: Change from pre- to post-intervention (4 weeks)
Fish Task: change of probability threshold to decision
Time frame: Change from pre- to post-intervention (4 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: Yes. All data we will be published on Zenodo under CC0 license.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Andreou, PD Dr. principal investigator
University of Basel
Stefan Borgwardt, Prof. Dr. principal investigator
University of Luebeck
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metacognitive training game in people with Schizophrenia and Related Disorders and Psychotic Disorders, run by Christina Andreou at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christina Andreou, PD. Dr. (+41 61 325 8157, christina.andreou@unibas.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of delusion severity (time frame: Change from pre- to post-intervention (4 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.