The effect of a cognitive behavioural program called Michaels Game on psychotic symptoms
| ISRCTN | ISRCTN37178153 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37178153 |
| Protocol serial number | Swiss National Science Foundation Grant: 32003B-121038 |
| Sponsor | Geneva University Hospitals (Switzerland) |
| Funder | Swiss National Science Foundation (Switzerland) Grant: 32003B-121038 |
- Submission date
- 06/04/2013
- Registration date
- 04/07/2013
- Last edited
- 22/09/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Psychosis is a mental disorder in which thought and emotions are impaired, causing a person to lose touch with reality. Medication is often used to treat people suffering from psychosis, but it is not always effective as patients often do not take their medication. The one-to-one talking therapy, cognitive behavioural therapy (CBT) has been shown to be a particularly effective treatment for psychosis, as it teaches patients to successfully manage their problems by changing their behaviour. “Michael’s game” is a card game which has been developed to help therapists and patients become familiar with CBT. Within the game, participants have to help “Michael” to find alternatives to the wrong conclusions that he draws from the situations described on each card. Michael’s game can then be used in order to predict how patients will respond to CBT. The aim of this study is to look at whether the use of Michael’s game is a feasible option for the treatment of patients with psychosis who are on the waiting list for CBT.
Who can participate?
Adults with a psychotic disorder taking anti-psychotic medication and undergoing treatment as an outpatient.
What does the study involve?
Patients are randomly divided into one of two groups. The first group (control group), continue their normal treatment and are placed on the waiting list for CBT. The second group (intervention group), continue their normal treatment and take part in Michael’s game. At the start of the study, all patients are given questionnaires and are interviewed in order to evaluate their medical history and population statistics. These tests are repeated again after three months and then after a further 6 months.
What are the possible benefits and risks of participating?
There is a very low risk to the patients who are participating, as Michael’s game is non-invasive and there is no evidence of it being harmful. A potential benefit of being in the intervention group is that it could lead to an improvement in the patients’ treatment.
Where is the study run from?
Geneva University Hospitals (Switzerland)
When is the study starting and how long is it expected to run for?
April 2008 to March 2011
Who is funding the study?
Swiss National Science Foundation (Switzerland)
Who is the main contact?
Dr Yasser Khazaal
Yasser.khazaal@hcuge.ch
Contact information
Scientific
Geneva University Hospitals
Service d'addictologie
Grand pré, 70C
Geneva
1206
Switzerland
| Phone | +41 795 53 56 82 |
|---|---|
| yasser.khazaal@hcuge.ch |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled multicentric blind assessment study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A multicentric randomized controlled study of the effect of a cognitive behavioural program called Michael's Game on psychotic symptoms |
| Study objectives | Our main hypothesis is that the subjects who will take part in the module Michaels Game will show a greater modification of their attitudes toward the positive psychotic symptomatology (in terms of anxiety inducing character, degree of preoccupation, conviction, and behaviour disturbances associated with these symptoms) and a better improvement of insight than control subjects on the waiting list. |
| Ethics approval(s) | Research Ethic Commission Geneva University Hospitals, 17th October 2008, ref: Protocol No 08-193 |
| Health condition(s) or problem(s) studied | Psychotic disorders |
| Intervention | Treatment as usual + Michaels Game vs. treatment as usual + waiting list Cognitive Therapy (psychotherapy) Group Format Game Format |
| Intervention type | Other |
| Primary outcome measure(s) |
Peters Delusion Inventors (PDI-21) - A 21-item scale that assesses the degree of expression of psychotic beliefs. Three dimensions of delusional beliefs are investigated: the degrees of preoccupation, of conviction, and of related anxiety. |
| Key secondary outcome measure(s) |
All measured at baseline, Months 3 (post Michael's Game Treatment) and six months later |
| Completion date | 31/03/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 166 |
| Key inclusion criteria | 1. Psychotic disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), diagnoses are established by experienced clinicians (from the psychiatric services teams) 2. Treatment in an outpatient setting, day hospital or rehabilitation unit 3. Age18-65 years 4. Positive psychotic symptoms defined by: a score of ≥ 3 on at least 2 of the items of the positive symptoms on the Brief psychiatry rating scale (BPRS) 5. Patients informed consent |
| Key exclusion criteria | 1. Evidence of organic brain disease, clinically significant concurrent medical illness or learning disability 2. Conceptual disorganization score on the BPRS of >5 3. Prior participation in the ''Michaels Game'' program 4. Cognitive behavioral therapy (CBT) of psychotic symptoms at the time of inclusion |
| Date of first enrolment | 01/04/2008 |
| Date of final enrolment | 31/03/2011 |
Locations
Countries of recruitment
- Italy
- Switzerland
Study participating centre
1206
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 28/04/2015 | Yes | No | |
| Results article | results | 01/12/2019 | 22/09/2020 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
22/09/2020: Publication reference added.
