Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04631939
Other study ID # 2020-02291
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2021
Est. completion date December 2023

Study information

Verified date May 2023
Source University of Basel
Contact Christina Andreou, PD. Dr.
Phone +41 61 325 8157
Email christina.andreou@unibas.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 36
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Germany Center for Integrative Psychiatry Lübeck Lübeck Schleswig-Holstein
Switzerland University Psychiatric Clinics Basel Basel Basel-Stadt

Sponsors (1)

Lead Sponsor Collaborator
Christina Andreou

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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)
Secondary 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)
Secondary 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)
Secondary 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)
See also
  Status Clinical Trial Phase
Completed NCT05321602 - Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder Phase 1
Terminated NCT03230097 - This Study Tests Whether BI 409306 Prevents Patients With a Specific Type of Mental Illness (Attenuated Psychosis Syndrome) From Becoming Worse. This Study Looks at How Well Patients Tolerate the Medicine and How Effective it is Over 1 Year Phase 2
Completed NCT03497663 - VIA Family - Family Based Early Intervention Versus Treatment as Usual N/A
Active, not recruiting NCT05726617 - Avatar Intervention for the Treatment of Cannabis Use Disorder in Patients With Severe Mental Health Disorders N/A
Not yet recruiting NCT03807388 - ReMindCare App for Patients From First Episode of Psychosis Unit. N/A
Recruiting NCT02874573 - Tocilizumab in Schizophrenia Phase 1
Completed NCT02906553 - The Role of Nitric Oxide in Cognition in Schizophrenia N/A
Terminated NCT02584114 - Brain Effects of Memory Training in Early Psychosis N/A
Withdrawn NCT02213887 - Study of the Effects of Pantoprazole on Levels of Prescribed Psychiatric Medications Phase 4
Completed NCT01981356 - Acceptance and Commitment Therapy for the Inpatient Treatment of Psychosis Phase 0
Terminated NCT02841956 - Reducing Duration of Untreated Psychosis Through Rapid Identification and Engagement N/A
Recruiting NCT02848469 - Irish Omega-3 Study Phase 2
Recruiting NCT02009969 - Serial Comparisons of Abdominal and Neurological MRI Scans N/A
Completed NCT02648321 - Motivational Intervention for Physical Activity in Psychosis N/A
Enrolling by invitation NCT00762866 - Psychiatric Genotype/Phenotype Project Repository
Completed NCT00484302 - Specialized Addiction Treatment Versus Treatment as Usual for Young Patients With Cannabis Abuse and Psychosis N/A
Completed NCT00844922 - Safety of Org 34517 900 mg in Patients Who Received Org 34517 in a Previous Trial (Study 28133/P05842) Phase 2
Completed NCT00130923 - Risperidone Long-acting Versus Oral Risperidone in Patients With Schizophrenia and Alcohol Use Disorder Phase 4
Completed NCT00455234 - Rapid Tranquillization Trial: TREC-India II Phase 3
Completed NCT00128479 - A United States Study of the Safety and Tolerability of Corlux for Psychotic Symptoms in Psychotic Major Depression Phase 3