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 November 2024
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
Study website
Contact information
Type
Public
Contact name
Dr Catherine Carr
ORCID ID
http://orcid.org/0000-0001-5179-2464
Contact details
Unit for Social and Community Psychiatry
Newham Centre for Mental health
East London Foundation NHS Trust
Glen Road
London
E13 8SP
United Kingdom
+44 (0)2075404380
c.e.carr@qmul.ac.uk
Additional identifiers
EudraCT/CTIS number
IRAS number
252526
ClinicalTrials.gov number
Protocol/serial number
IRAS 252526, NIHR/HTA 17/29/01
Study information
Scientific title
Effectiveness of group arts therapy compared to group counselling for diagnostically heterogeneous psychiatric community patients: RAndomised controlled trial in mental health services
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
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
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
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
30/11/2024
Reason abandoned (if study stopped)
Eligibility
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 type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
420
Total final enrolment
425
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 centre
East London NHS Foundation Trust
Unit for Social and Community Psychiatry
Newham Centre for Mental Health
Glen Road
London
E13 8SP
United Kingdom
Study participating centre
Avon and Wiltshire Partnership NHS Trust
Research & Development Office
Blackberry Hill Hospital
Bristol
BS16 2EW
United Kingdom
Study participating centre
Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
St Nicholas Hospital
Jubilee Road
Gosforth
Newcastle upon Tyne
NE3 3XT
United Kingdom
Study participating centre
Central and North West London NHS Foundation Trust
Trust Headquarters
350 Euston Road
Regents PLACE
London
NW1 3AX
United Kingdom
Sponsor information
Organisation
East London NHS Foundation Trust
Sponsor details
Noclor
1st Floor
Bloomsbury Building
St Pancras Hospital
4 St Pancras Way
London
NW1 0PE
England
United Kingdom
+44 (0)203 3173045
sponsor.noclor@nhs.net
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
Not defined
Funder name
National Institute for Health Research
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
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
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.
Intention to publish date
30/11/2025
Individual participant data (IPD) sharing plan
The data sharing plans for the current study are unknown and will be made available at a later date
IPD sharing plan summary
Data sharing statement to be made available at a later date
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