Interactive group art therapy as an adjunctive treatment for people with schizophrenia

ISRCTN ISRCTN46150447
DOI https://doi.org/10.1186/ISRCTN46150447
Secondary identifying numbers HTA 04/39/04
Submission date
05/06/2006
Registration date
10/07/2006
Last edited
12/07/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

Background and study aims
Schizophrenia is a severe mental illness that causes considerable distress and can damage other aspects of a person's life. People with schizophrenia often find it difficult to express themselves and their social functioning (their ability to look after themselves and get on with others) may also suffer. While medication can help to reduce these problems, many people continue to experience symptoms despite talking regular medication. Art therapy is a form of psychotherapy that may be particularly helpful for people who find it difficult to express themselves verbally. It is usually delivered in groups of up to eight people held weekly over a period of several months or years. Recent research has shown that group art therapy may improve the mental health of people with schizophrenia but studies have been too small to be sure whether it really makes a difference compared to other groups that are often used as part of the care that services usually provide. We would therefore like to carry out a larger study in which we examine the mental health, social functioning, and cost-effectiveness of art therapy for people with schizophrenia.

Who can participate?
Patients aged over 18 with schizophrenia

What does the study involve?
Participants are randomly allocated to receive either usual care, usual care plus a place in a weekly activity group, or usual care plus weekly group art therapy. Those allocated a place in the activity group or usual care are offered art therapy at the end of the study.

What are the possible benefits and risks of participating?
This study will help us learn more about the forms of psychological intervention that help people with this important condition.

Where is the study run from?
University College London (UK)

When is the study starting and how long is it expected to run for?
November 2006 to October 2010

Who is funding the study?
Health Technology Assessment Programme (UK)

Who is the main contact?
Dr Helen Killaspy
h.killaspy@medsch.ucl.ac.uk

Contact information

Dr Helen Killaspy
Scientific

Department of Mental Health Sciences
University College London
Second Floor
Royal Free Hospital
London
NW3 2PF
United Kingdom

Phone +44 (0)207 794 0500 ext 33719
Email h.killaspy@medsch.ucl.ac.uk

Study information

Study designThree-arm parallel non-blinded randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleInteractive group art therapy as an adjunctive treatment for people with schizophrenia
Study acronymMATISSE
Study hypothesis1. Among people with schizophrenia, adjunctive interactive group art therapy is associated with improved global functioning at 24 months compared to attention control treatment or standard care alone.
2. In the treatment of people with schizophrenia in secondary care settings, adjunctive interactive group art therapy is more cost-effective than attention control treatment or standard care alone.

More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/043904
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0017/51092/PRO-04-39-04.pdf
Ethics approval(s)Cambridgeshire 1 Research Ethics Committee (formerly Huntingdon Research Ethics Committee), 08/09/2006, ref: 06/Q0104/82
ConditionSchizophrenia
InterventionThe trial has three arms. As well as the intervention group (group art therapy) there are two other arms: attention control and treatment as usual. The attention control includes activity groups which will function in terms of structure, number of facilitators and number of participants in a similar manner to the group art therapy i.e. they will run weekly for 90 minutes with eight members and two facilitators. They will involve any activity with the exception of anything that uses art or art materials e.g. outings, current affairs discussion, newspaper groups, games etc. The treatment-as-usual arm will have no specific intervention.
Intervention typeBehavioural
Primary outcome measureGlobal functioning assessed using the Global Assessment of Functioning Scale
Secondary outcome measures1. Symptoms assessed using the Positive and Negative Syndrome Scale
2. Medication concordance will be assessed using the Morisky Scale
3. Quality of life will be assessed using Euroqol EQ-5D
4. Service costs will be assessed using the Client Service Receipt Inventory
5. Social function using the Social Function Schedule
6. Wellbeing will be assessed using the Psychological General Well Being Index
7. Satisfaction with services will be assessed using the Client Satisfaction Questionnaire
8. Engagement with services will be assessed using the Service Engagement Scale
9. Occupational and housing status
10. Adverse events
Overall study start date01/11/2006
Overall study end date31/10/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants376
Participant inclusion criteriaAll those treated by secondary mental health services in the four study centres who are aged over 18 years and have a clinical diagnosis of schizophrenia, confirmed by an examination of case notes using operationalised criteria (OPCRIT), will be eligible to take part in the study
Participant exclusion criteria1. Patients who are unwilling to provide written informed consent
2. Patients who speak insufficient English and are not able to complete baseline assessment
3. Have severe cognitive impairment
4. Are already receiving art therapy or any other art therapies (music therapy, drama therapy, or dance/ movement therapy)
Recruitment start date01/11/2006
Recruitment end date31/10/2010

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University College London
London
NW3 2PF
United Kingdom

Sponsor information

Imperial College London (UK)
Government

South Kensington Campus
London
SW7 2AZ
United Kingdom

Website http://www3.imperial.ac.uk/
ROR logo "ROR" https://ror.org/041kmwe10

Funders

Funder type

Government

Health Technology Assessment Programme
Government organisation / National government
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 27/08/2010 Yes No
Results article results 28/02/2012 Yes No
Results article results 01/08/2012 Yes No

Editorial Notes

01/05/2008: the overall trial end date was changed from 31/10/2009 to 31/10/2010.