Condition category
Mental and Behavioural Disorders
Date applied
30/08/2018
Date assigned
12/09/2018
Last edited
04/12/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Suspended

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 December 2021

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

Trial website

www.elft.nhs.uk/era

Contact information

Type

Public

Primary contact

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

Type

Public

Additional contact

Ms Leoni Koutsou

ORCID ID

Contact details

Unit for Social and Community Psychiatry
Newham Centre for Mental Health
Glen Road
London
E13 8SP
United Kingdom
+44 (0)20 7540 4210
leoni.koutsou@nhs.net

Additional identifiers

EudraCT number

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

Current ethics approval as of 15/01/2020:
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

Previous ethics approval:
To be submitted to NHS Research Ethics Committee and HRA approval

Study design

Interventional pragmatic multi-centre two-arm randomised controlled trial with internal pilot, economic evaluation and nested process evaluation

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial 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

Phase

Drug names

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 trial start date

01/09/2018

Overall trial end date

31/12/2021

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

Patient

Age group

Adult

Gender

Both

Target number of participants

420

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

01/11/2018

Recruitment end date

31/12/2021

Locations

Countries of recruitment

United Kingdom

Trial 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

Trial participating centre

Avon and Wiltshire Partnership NHS Trust
Research & Development Office Blackberry Hill Hospital
Bristol
BS16 2EW
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
United Kingdom

Sponsor type

Research organisation

Website

www.noclor.nhs.net

Funders

Funder type

Not defined

Funder name

National Institute for Health Research

Alternative name(s)

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.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

01/12/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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.