Condition category
Mental and Behavioural Disorders
Date applied
06/04/2013
Date assigned
04/07/2013
Last edited
21/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Yasser Khazaal

ORCID ID

Contact details

Geneva University Hospitals
Service d'addictologie
Grand pré
70C
Geneva
1206
Switzerland
+41 795 53 56 82
yasser.khazaal@hcuge.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Swiss National Science Foundation Grant: 32003B-121038

Study information

Scientific title

A multicentric randomized controlled study of the effect of a cognitive behavioural program called “Michael’'s Game” on psychotic symptoms

Acronym

Study hypothesis

Our main hypothesis is that the subjects who will take part in the module “Michael’s 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

Research Ethic Commission Geneva University Hospitals, 17th October 2008, ref: Protocol No 08-193

Study design

Randomized controlled multicentric blind assessment study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet (in French)

Condition

Psychotic disorders

Intervention

Treatment as usual + Michael’s Game vs. treatment as usual + waiting list

Cognitive Therapy (psychotherapy)
Group Format
Game Format

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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.
This scale has notably been used to investigate the benefits of cognitive and behavioural therapies of psychoses (Garety et al., 1997 and Kuipers et al., 1997 and 1998).
Measured at baseline, Months 3 (post Michael's Game Treatment) and six months later

Secondary outcome measures

All measured at baseline, Months 3 (post Michael's Game Treatment) and six months later
1. The BPRS (Brief psychiatry rating scale) (Overall et al. 1961) An 18-item scale that measures the severity of the symptoms in functional psychoses. Comes in the form of a semi-structured interview.
2. The BCIS (Beck Cognitive Insight Scale (Beck et al. 2004) A 15-item scale that assesses self-reflectiveness (insight and desire to recognize its fallibility) and self-certainty (certainty regarding patients’ beliefs and judgement) regarding the interpretation patients have for their experience.This self-report questionnaire enables the research units to access the patients’ ability to evaluate their abnormal experiences and their erroneous inferences.
3. PDI 21 Peters and al. Delusions Inventory Peters et al. (1999) 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. This scale has notably been used to investigate the benefits of cognitive and behavioural therapies of psychoses (Garety et al., 1997 and Kuipers et al., 1997 and 1998)
4. The GAF [Global Assessment of Functioning] (DSM-IV) A scale that allows for an evaluation of the level of global functioning (psychological, social, and professional) of a person by means of a unique score. It can be divided into ten levels of functioning. The description of each level has two components: the first one corresponds to the severity of the symptoms, and the second one to functioning. This scale has good psychometric qualities and is a tool frequently used in clinical routine.
5. The SOFAS [Social and Occupational Functioning Assessment Scale] (DSM-IV) In contrast with the GAF, the SOFAS focuses on the individual's level of social and occupational functioning while excluding severity of symptoms.
6. The MADS (Maudsley Assessment of Delusions Schedule) (Wessely et al. 1993) This scale has particularly been created to bring to the fore links between the actions resulting from the main belief and its phenomenological qualities. It is composed of 8 subscales: conviction, beliefs, emotion, action, idiosyncrasy, preoccupation, systematization, insight. It consists of a standardized semi-structured interview.
7. CSSRI-EU - Client Socio-Demographic and Service Receipt Inventory (Chisholm et al., 2000) This tool is made up of five sections consisting of structured interviews to assess: socio-demographic, normal living conditions, employment and income, service receipt, medication profile

Overall trial start date

01/04/2008

Overall trial end date

31/03/2011

Reason abandoned

Eligibility

Participant 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. Patient’s informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

166

Participant 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 ''Michael’s Game'' program
4. Cognitive behavioral therapy (CBT) of psychotic symptoms at the time of inclusion

Recruitment start date

01/04/2008

Recruitment end date

31/03/2011

Locations

Countries of recruitment

Italy

Trial participating centre

Geneva University Hospitals
Geneva
1206
Switzerland

Sponsor information

Organisation

Geneva University Hospitals (Switzerland)

Sponsor details

Service d'addictologie
Grand pré
70C
Geneva
1206
Switzerland
+41 795 53 56 82
yasser.khazaal@hcuge.ch

Sponsor type

Hospital/treatment centre

Website

http://www.hug-ge.ch/

Funders

Funder type

Government

Funder name

Swiss National Science Foundation (Switzerland) Grant: 32003B-121038

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 Results in http://www.ncbi.nlm.nih.gov/pubmed/25972817

Publication citations

  1. Results

    Khazaal Y, Chatton A, Dieben K, Huguelet P, Boucherie M, Monney G, Lecardeur L, Salamin V, Bretel F, Azoulay S, Pesenti E, Krychowski R, Costa Prata A, Bartolomei J, Brazo P, Traian A, Charpeaud T, Murys E, Poupart F, Rouvière S, Zullino D, Parabiaghi A, Saoud M, Favrod J, Reducing delusional conviction through a cognitive-based group training game: a multicentre randomized controlled trial, Frontiers in Psychiatry, 2015, 6, 66, doi: 10.3389/fpsyt.2015.00066.

Additional files

Editorial Notes