Secure care hospital evaluation of art therapy
| ISRCTN | ISRCTN57406593 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57406593 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 319325 |
| Protocol serial number | CPMS 54895, NIHR301264 |
| Sponsor | Cumbria Northumberland Tyne and Wear NHS Foundation Trust |
| Funders | NIHR Academy, National Institute for Health and Care Research |
- Submission date
- 16/01/2023
- Registration date
- 18/01/2023
- Last edited
- 25/11/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
In the past people who have a learning disability were often excluded from taking part in research. This means that knowing what works well for them is not always clear. Lots of psychotherapies available to help people with mental health difficulties are based on talking, which might not always be the best approach for people with learning disabilities/difficulties. Doing artwork or creative things within art psychotherapy can be a helpful way for people to communicate about themselves. Interpersonal art psychotherapy has been designed to help people with learning disabilities in secure care. The art psychotherapist encourages people to use creative ways to express the things they would like to feel better about.
We want to find out if interpersonal art psychotherapy is helpful and value for money for people with learning difficulties who are in secure care. We will be testing if interpersonal art psychotherapy works better than the standard care that is being provided.
Who can participate?
Patients aged 18 to 60 years, with a Learning Disability Screening Questionnaire (LSDQ) score of 57 or below (indicating the presence of learning disability/borderline intellectual functioning/learning difficulty).
What does the study involve?
During the study a computer will decide which people in the research get art therapy straight away and which people wait a bit longer. All participants will be asked to complete some questionnaires about your mental and physical health. You will be asked questions at the start, after four months, and after nine months.
What are the possible benefits and risks of participating?
Art therapy may help participants to feel better. Participants will have to give up some of their free time to take part and Sometimes people can feel emotional during and after art therapy, but your art therapist or staff will help you with this
Where is the study run from?
Cumbria Northumberland Tyne and Wear NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
July 2022 to August 2025
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).
Who is the main contact?
Paula Foscarini-Craggs, Schema@cardiff.ac.uk
Contact information
Scientific
Centre for Trials Research
School of Medicine
College of Biomedical & Life Sciences
Cardiff University
4th Floor, Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4YS
United Kingdom
| Phone | +44 (0)29 206 87522 |
|---|---|
| Schema@cardiff.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Participant information sheet | 43060 SCHEMA PIS V1.3 13.01.2023.pdf |
| Scientific title | Secure Care Hospital Evaluation of Manualised (interpersonal) Art-psychotherapy: a randomised controlled trial |
| Study acronym | SCHEMA |
| Study objectives | Is interpersonal art therapy effective at reducing the frequency and severity of aggressive behaviour in adult secure care? |
| Ethics approval(s) | Approved 10/01/2023, London - City & East Research Ethics Committee (Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT, UK; +44 207 1048134; cityandeast.rec@hra.nhs.uk), ref: 23/LO/0026 |
| Health condition(s) or problem(s) studied | Learning disorders |
| Intervention | Participants will be randomised on a one-to-one basis to receive either interpersonal art therapy or be placed on a wait list to receive interpersonal art therapy after they complete their trial participation. Randomisation will be stratified by diagnosis of psychosis and sex. The interpersonal art therapy comprises 12 sessions with up to 3 additional sessions (a total of 15 possible sessions) which look at personal goals, coping and self-managed, life events and imagined futures. Therapy sessions will be audio recorded. The recordings will be analysed as part of the assessment of the therapeutic process. An assessment of the frequency and severity of aggressive behaviours will be completed weekly after the completion of therapy up to 38 weeks post-randomisation. During the trial, participants will complete two assessments of the quality of life, and a measure of distress associated with psychiatric symptoms at 19 and 38 weeks post-randomisation. At 19 weeks and 38 weeks post-randomisations, healthcare staff will complete proxy measures of the participant's quality of life, and healthcare resource use. After the 38 week follow-up has been completed, participants will be offered the opportunity to participate in the interpersonal art therapy. A subset of participants will also be asked if they want to take part in an interview to assess their experiences of taking part in interpersonal art therapy. Interviews will last approximately 1 hour. Therapists will also be asked to take part in interviews to assess their experience of providing therapy and its implications for clinical practice. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Aggressive behaviour is measured using the Modified Overt Aggression Scale (MOAS) at week 19, weekly between week 19-38, and week 38 |
| Key secondary outcome measure(s) |
1. Health Economic analysis will be measured using the EQ5D, the Recovery Quality of Life Scale, and a resource use questionnaire, at baseline, week 19, and week 38 |
| Completion date | 31/08/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | All |
| Target sample size at registration | 150 |
| Total final enrolment | 50 |
| Key inclusion criteria | Current inclusion criteria as of 28/02/2024: 1. An inpatient in an NHS secure hospital/unit/service with the presence of learning disability/borderline intellectual functioning indicated by either (a) meeting validated assessment criteria (recognised cognitive testing and adapting functioning assessment), or (b) a score of 57 or below on the Learning Disability Screening Questionnaire (LDSQ) 2. Age 18 to 60 years 3. Able to give informed consent 4. A HONOS (Health of the Nation Outcome Scale) score between 1 and 4 for item 1 (Overactive, aggressive, disruptive, or agitated behaviour / Behavioural problems directed at others) 5. The participants' involvement in the study is supported by their responsible clinician and/or multidisciplinary team (MDT) Previous inclusion criteria: 1. An inpatient in an NHS secure hospital/unit/service with a Learning Disability Screening Questionnaire (LSDQ) score of 57 or below (indicating the presence of learning disability/borderline intellectual functioning/learning difficulty) 2. Age 18 to 60 years (within the age range for the service) 3. Able to give informed consent 4. A score between 1 and 4 on question 1 of the Health of the Nation Outcome Scale Working Age Adult or Learning Disability version (HONOS-WAA or HONOS-LD) 5. The patient’s involvement in the study is supported by their responsible clinician and/or multidisciplinary team (MDT) |
| Key exclusion criteria | Current exclusion criteria as of 28/02/2024: 1. Unable to give informed consent 2. Learning disability/borderline intellectual functioning not indicated based on a validated assessment or screening questionnaire (i.e. not meeting validated assessment criteria or a LDSQ Score >57) 3. A HONOS score of 0 for item 1 4. Planned discharge within 12 months of the start of the study 5. Unstable/unmanaged psychotic symptoms requiring active assessment or treatment including medication dose titration (i.e., dose adjustment in the previous 4 weeks or with potential further dose adjustment planned for the following 4 weeks) Previous exclusion criteria: 1. LDSQ Screening score >57 2. Unable to give informed consent 3. A score of 0 on question 1 of the HONOS-WAA or HONOS-LD 4. Planned discharge within 12 months of the start of the study 5. Receiving active assessment or treatment for acute or unstable/unmanaged psychotic symptoms including medication dose titration |
| Date of first enrolment | 01/02/2023 |
| Date of final enrolment | 30/11/2024 |
Locations
Countries of recruitment
- United Kingdom
- England
- Scotland
Study participating centres
Jubilee Road
Gosforth
Newcastle upon Tyne
NE3 3XT
England
9 Alie Street
London
E1 8DE
England
50 Summer Hill Road
Birmingham
B1 3RB
England
Newbridge Hill
Bath
BA1 3QE
England
Southall
UB2 4SD
England
Duncan Macmillan House
Porchester Road
Nottingham
NG3 6AA
England
2-4 Waterloo Place
Edinburgh
EH1 3EG
Scotland
Old North Road
Bassingbourn
Royston
SG8 5JP
England
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The data set will be available upon request by emailing Dr Paula Foscarini-Craggs (schema@Cardiff.ac.uk) at the end of the trial. While there are no specific criteria, any data requests will be reviewed in accordance with the Centre for Trials Research data sharing policy and procedures. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 07/03/2025 | 17/04/2025 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | version 1.3 | 13/01/2023 | 18/01/2023 | No | Yes |
| Participant information sheet | Pictorial PIS version 1.2 |
13/01/2023 | 18/01/2023 | No | Yes |
| Participant information sheet | Therapist information sheet version 1.2 |
13/01/2023 | 18/01/2023 | No | Yes |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 1.3 | 22/11/2022 | 18/01/2023 | No | No |
| Statistical Analysis Plan | 01/07/2025 | 02/07/2025 | No | No |
Additional files
- 43060 SCHEMA Protocol V1.3 22.11.2022.pdf
- Protocol file
- 43060 SCHEMA PIS V1.3 13.01.2023.pdf
- Participant information sheet
- 43060 SCHEMA Pictorial PIS V1.2 13.01.2023.pdf
- Pictorial PIS
- 43060 SCHEMA Therapist Information Sheet V1.2 13.01.2023.pdf
- Therapist information sheet
Editorial Notes
25/11/2025: Total final enrolment added.
02/07/2025: Publication reference added.
17/04/2025: Publication reference added.
14/04/2025: The overall end date was changed from 31/05/2025 to 31/08/2025.
21/08/2024: The recruitment end date was changed from 30/06/2024 to 30/11/2024.
28/02/2024: The following changes were made to the study record:
1. The inclusion and exclusion criteria were updated.
2. The target number of participants was changed from 200 to 150.
3. The recruitment end date was changed from 31/03/2024 to 30/06/2024.
4. NHS Lothian and Kneesworth House Hospital were added to the study participating centres.
10/10/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2023 to 31/03/2024.
2. The study participating centre Nottinghamshire Healthcare NHS Foundation Trust was added.
16/01/2023: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
