Condition category
Mental and Behavioural Disorders
Date applied
05/06/2006
Date assigned
10/07/2006
Last edited
12/07/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Helen Killaspy

ORCID ID

Contact details

Department of Mental Health Sciences
University College London
Second Floor
Royal Free Hospital
London
NW3 2PF
United Kingdom
+44 (0)207 794 0500 ext 33719
h.killaspy@medsch.ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 04/39/04

Study information

Scientific title

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

Acronym

MATISSE

Study hypothesis

1. 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

Cambridgeshire 1 Research Ethics Committee (formerly Huntingdon Research Ethics Committee), 08/09/2006, ref: 06/Q0104/82

Study design

Three-arm parallel non-blinded randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

Schizophrenia

Intervention

The 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 type

Behavioural

Phase

Drug names

Primary outcome measures

Global functioning assessed using the Global Assessment of Functioning Scale

Secondary outcome measures

1. 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 trial start date

01/11/2006

Overall trial end date

31/10/2010

Reason abandoned

Eligibility

Participant inclusion criteria

All 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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

376

Participant exclusion criteria

1. 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 date

01/11/2006

Recruitment end date

31/10/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University College London
London
NW3 2PF
United Kingdom

Sponsor information

Organisation

Imperial College London (UK)

Sponsor details

South Kensington Campus
London
SW7 2AZ
United Kingdom

Sponsor type

Government

Website

http://www3.imperial.ac.uk/

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/20799930
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22364962
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22374932

Publication citations

  1. Protocol

    Crawford MJ, Killaspy H, Kalaitzaki E, Barrett B, Byford S, Patterson S, Soteriou T, O'Neill FA, Clayton K, Maratos A, Barnes TR, Osborn D, Johnson T, King M, Tyrer P, Waller D, The MATISSE study: a randomised trial of group art therapy for people with schizophrenia., BMC Psychiatry, 2010, 10, 65, doi: 10.1186/1471-244X-10-65.

  2. Results

    Crawford MJ, Killaspy H, Barnes TR, Barrett B, Byford S, Clayton K, Dinsmore J, Floyd S, Hoadley A, Johnson T, Kalaitzaki E, King M, Leurent B, Maratos A, O'Neill FA, Osborn D, Patterson S, Soteriou T, Tyrer P, Waller D, , Group art therapy as an adjunctive treatment for people with schizophrenia: a randomised controlled trial (MATISSE)., Health Technol Assess, 2012, 16, 8, iii-iv, 1-76, doi: 10.3310/hta16080.

  3. Results

    Crawford MJ, Killaspy H, Barnes TR, Barrett B, Byford S, Clayton K, Dinsmore J, Floyd S, Hoadley A, Johnson T, Kalaitzaki E, King M, Leurent B, Maratos A, O'Neill FA, Osborn DP, Patterson S, Soteriou T, Tyrer P, Waller D, , Group art therapy as an adjunctive treatment for people with schizophrenia: multicentre pragmatic randomised trial., BMJ, 2012, 344, e846.

Additional files

Editorial Notes

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