Effectiveness of group arts therapy for mixed diagnosis community mental health patients
| ISRCTN | ISRCTN88805048 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88805048 |
| IRAS number | 252526 |
| Secondary identifying numbers | IRAS 252526, NIHR/HTA 17/29/01 |
- Submission date
- 30/08/2018
- Registration date
- 12/09/2018
- Last edited
- 22/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Arts therapies use different art forms and creative activities to help people living with mental illness. These include music therapy, dance-movement therapy and art therapy. They are usually provided in regular group meetings over a few months. Arts therapies may help patients to express emotions and have experiences that might not be possible in talking therapies. Different people prefer different art forms. If patients can choose which art form they like best, they may be more likely to attend and benefit from this. While arts therapies are popular with many patients, they are not always provided in NHS services. So far, there has been little research to show that they are helpful. Existing research has involved people with only one diagnosis (such as schizophrenia). This is different to how arts therapies groups are provided, as they usually include people with different mental illnesses.
This study aims to test if arts therapies groups are effective for patients with different types of mental illness.
Who can participate?
Adult patients with a main diagnosis of schizophrenia, depression or anxiety, in community mental health services who are currently finding their symptoms difficult
What does the study involve?
Participants will be divided in two groups randomly. Half will receive their preferred form of arts therapy group, which could be art, dance or music. The other half will be offered group meetings with general talking and support, but no use of arts. Patients can attend for up to 40 sessions over 5 months. We will interview patients at the beginning and end of treatment, 6 and 12 months later. We will then compare the two groups to see if patients receiving arts therapies had a better improvement of symptoms and quality of life. There will also be optional interviews about patient experiences with the therapy.
What are the possible benefits and risks of participating?
Current research suggests that group therapy can be helpful to meet others who are in a similar situation. Groups can be a useful source of support. Research suggests that arts therapies are enjoyable and can be helpful to express feelings and interact with others. Some research suggests that arts therapies can help with symptoms, but we cannot guarantee this.
Some people feel worse before they start to feel better in group therapy. Using the arts can sometimes put us in touch with painful feelings or memories that can feel overwhelming. If any of this happens during group therapy, therapists will be available for support. Some of the research questions ask about sensitive areas such as symptoms and life. We will support participants so that they feel as comfortable as they can, and the meeting can be stopped at any time needed. Participants are not obliged to answer a question if they do not wish to.
Where is the study run from?
Unit for Social and Community Psychiatry, Newham Centre for Mental Health, East London NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
September 2018 to October2024
Who is funding the study?
The National Institute for Health Research, Health Technology Assessment programme (UK)
Who is the main contact?
Dr Catherine Carr
c.e.carr@qmul.ac.uk
Contact information
Public
Unit for Social and Community Psychiatry
Newham Centre for Mental health
East London Foundation NHS Trust
Glen Road
London
E13 8SP
United Kingdom
 ORCID ID |
0000-0001-5179-2464 |
|---|---|
| Phone | +44 (0)2075404380 |
| c.e.carr@qmul.ac.uk |
Study information
| Study design | Interventional pragmatic multi-centre two-arm randomized controlled trial with internal pilot, economic evaluation and nested process evaluation |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Effectiveness of group arts therapy compared to group counselling for diagnostically heterogeneous psychiatric community patients: RAndomised controlled trial in mental health services |
| Study acronym | ERA |
| Study hypothesis | For patients with a clear preference for a single arts modality, the addition of arts within therapeutic groups will reduce symptom distress to a greater degree than wider non-specific group effects (as seen in talking therapies such as group counselling) alone. |
| Ethics approval(s) | Approved 20/12/2018, Yorkshire & The Humber - South Yorkshire Research Ethics Committee (Mercure Doncaster Centre Danum, High Street, Doncaster, DN1 1DN; 0207 104 8091, 0207 104 8079; nrescommittee.yorkandhumber-southyorks@nhs.net), ref: 18/YH/0464 |
| Condition | Psychological distress in people with schizophrenia and related psychotic disorders, mood disorders and anxiety or other non-psychotic disorders |
| Intervention | Participants will be randomly allocated with equal chance to receive either their preferred form of group arts therapy (art, dance movement or music therapy), or group counselling. Participants will choose the modality of arts therapy that they prefer prior to randomisation. Randomisation will be conducted independently by the Pragmatic Clinical Trials Unit. Researchers conducting assessments will be blind to the intervention. All groups (arts therapy and counselling) will run for up to 90 minutes, twice per week for 20 weeks. Follow-up assessments will be taken immediately at the end of 20 weeks of treatment, 6 months and 12 months post-treatment. |
| Intervention type | Other |
| Primary outcome measure | Psychological distress, assessed using the Brief Symptom Inventory Global Severity Index, at the end of 20 weeks of treatment |
| Secondary outcome measures | The following are assessed at the end of 20 weeks of treatment, and 6 and 12 months post-treatment: 1. Psychological distress, assessed using the Brief Symptom Inventory (all subscales) 2. Observer-rated psychiatric symptoms, assessed using the Brief Psychiatric Rating Scale (BPRS) 3. Quality of life, assessed using the Manchester Short Assessment of Quality of Life (MANSA) 4. Objective social situation, assessed using the Objective Social Outcomes Index (SIX) 5. Use of health and social care, assessed using the Client Services Receipt Inventory (CSRI) 6. Self-related health to estimate Quality-adjusted life years (QALYS), assessed using the EQ-5D-3L questionnaire |
| Overall study start date | 01/09/2018 |
| Overall study end date | 01/10/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 420 |
| Total final enrolment | 425 |
| Participant inclusion criteria | 1. Outpatient in secondary mental health care 2. Motivation to attend group arts therapy for 5 months and expression of preference for one of three forms 3. Aged 18 years or older 4. Primary diagnosis of ICD-10 - diagnosed with at least one of the following (participants are not required to be diagnosed with all three): 4.1. F2 (schizophrenia and related psychotic disorders) 4.2. F3 (mood disorders) 4.3. F4 (anxiety and other non-psychotic disorders) 5. Duration of current mental disorder of 6 months or longer 6. At least moderate symptom level on BSI (score of 1.65 or above on Global Severity Index) 7. Capacity to provide informed consent |
| Participant exclusion criteria | 1. Primary diagnosis of organic mental disorder (F0), substance misuse (F1), personality disorder (F6) 2. Duration of current mental disorder <6 months (i.e. patients with short-term crises) 3. Physical condition that prevents attendance of group arts therapies 4. Insufficient command of English for communication with other group members and therapists. |
| Recruitment start date | 01/02/2019 |
| Recruitment end date | 28/02/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Newham Centre for Mental Health
Glen Road
London
E13 8SP
United Kingdom
Blackberry Hill Hospital
Bristol
BS16 2EW
United Kingdom
Jubilee Road
Gosforth
Newcastle upon Tyne
NE3 3XT
United Kingdom
350 Euston Road
Regents PLACE
London
NW1 3AX
United Kingdom
Sponsor information
Hospital/treatment centre
Noclor
1st Floor, Bloomsbury Building, St Pancras Hospital
4 St Pancras Way
London
NW1 0PE
England
United Kingdom
| Phone | +44 (0)203 3173045 |
|---|---|
| sponsor.noclor@nhs.net | |
| Website | www.noclor.nhs.net |
"ROR" |
https://ror.org/01q0vs094 |
Funders
Funder type
Not defined
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/07/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | A final report will be prepared for publication via the open access NIHR HTA journal. Further publications will be submitted to peer-reviewed journals. Lay summaries will be made available via the study website and we will run workshops on the study interventions and findings. |
| IPD sharing plan | For data sharing please contact: Dr Catherine Carr - c.e.carr@qmul.ac.uk |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version v5.0 | 26/02/2020 | 04/12/2020 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol article | 26/08/2023 | 29/08/2023 | Yes | No | |
| Protocol file | version 8 | 30/10/2022 | 05/04/2024 | No | No |
Additional files
- ISRCTN88805048_Protocol_v5.0_26Feb2020.pdf
- Uploaded 04/12/2020
- ISRCTN88805048_PROTOCOL_V8_30Oct22.pdf
Editorial Notes
22/11/2024: The following changes were made to the trial record:
1. The overall end date was changed from 30/11/2024 to 01/10/2024.
2. The intention to publish date was changed from 30/11/2025 to 31/07/2025.
3. The participant level data sharing statement was added.
05/04/2024: The following changes have been made to the study record:
1. Protocol and total final enrolment added.
2. The recruitment start date was changed from 01/11/2018 to 01/02/2019.
3. Contact details updated.
10/11/2023: The following changes were made:
1. The overall study end date was changed from 30/11/2023 to 30/11/2024
2. The intention to publish date was changed from 01/12/2024 to 30/11/2025.
9/08/2023: Publication reference added.
06/02/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2021 to 28/02/2023.
2. The overall end date was changed from 31/12/2021 to 30/11/2023.
3. The intention to publish date was changed from 01/12/2021 to 01/12/2024.
4. The plain English summary was updated to reflect these changes.
5. The trial participating centres Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust and Central and North West London NHS Foundation Trust were added.
6. The recruitment resumed.
17/09/2021: Internal review.
04/12/2020: The following changes have been made:
1. Due to current public health guidance, recruitment for this study has been paused.
2. The recruitment end date has been changed from 31/12/2020 to 31/12/2021.
3. The trial website has been added.
4. A public contact has been added.
5. Uploaded protocol v5.0 26Feb2020 (not peer reviewed).
09/07/2020: The trial contact details have been made publicly visible.
16/03/2020: Internal review.
15/01/2020: The following changes have been made:
1. The recruitment end date has been changed from 31/12/2019 to 31/12/2020.
2. The ethics approval has been updated.
3. The IRAS number has been added.
