Feasibility of intensive group music therapy
| ISRCTN | ISRCTN94605631 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94605631 |
| Secondary identifying numbers | 34200 |
- Submission date
- 03/04/2017
- Registration date
- 04/04/2017
- Last edited
- 27/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
This study involves people admitted to hospital for assessment and treatment of mental health problems (acute psychiatric in-patient care). People are admitted if they are experiencing a crisis in their mental health and are at risk of harm. The person may not have experienced mental health problems before or may have symptoms that have become worse. Admission to hospital can be a frightening experience and the person may be admitted against their will (sectioned). During hospital admission, assessments are made by different health-care professions. Medication is prescribed along with access to groups and psychological therapy which aims to support the person in their recovery and to return home as quickly as possible. Music therapy is one form of arts therapy that is often provided in groups in hospitals. The study team has developed an approach to music therapy which is provided four times per week for people in hospital for mental health problems. In order to conduct a study to find out how effective the approach is, it is important to conduct a small study to find out how best to do this so that we can make sure this is done properly and is acceptable to people who take part. The aim of this study is to find out if it is feasible to conduct a research study in this area.
Who can participate?
Adults who have been admitted to hospital for assessment and treatment of mental health problems.
What does the study involve?
The study has two parts. In part one, adults on four hospital wards are invited to participate. If they agree to take part, the researcher goes through an initial assessment and ask questions about symptoms, interest in music, mood, relationships with others and satisfaction with treatment. After this assessment, participants are randomly allocated to one of two groups. Those in the first group attend an off-ward music therapy group for 60 minutes, 4 times per week for up to 4 weeks. Those in the second group continue to receive usual care, which involves being able to access all other care provided in hospital apart from music therapy.
In part two, adults on two wards, admitted to hospital are invited to participate. One ward has an on-ward music therapy group that runs for 3 times per week. At the other ward does not have music therapy input. Patients on both wards are invited to take part as above to complete the assessments only.
In both parts of the study, the initial assessments are repeated after two and four weeks and three and six months. An optional interview is offered at four weeks for participants to tell the researchers what their experience of taking part in the study and music therapy was like.
What are the possible benefits and risks of participating?
There are no guaranteed benefits involved with taking part, however existing research into music therapy for people in hospital with mental health problems suggests it might help with motivation, symptoms, mood and relationships. Participants may value being able to share their experiences to provide information on how to improve group music therapy in hospitals. There is a small risk that in music therapy some people find the music in the group noisy or upsetting. In addition, participants might find it difficult to read the questionnaires. The researcher can help if this is the case. Some of the questions might cause discomfort or upset.
Where is the study run from?
1. Newham Centre for Mental Health (UK)
2. Tower Hamlets Centre for Mental Health (UK)
When is the study starting and how long is it expected to run for?
April 2016 to August 2018
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Dr Catherine Carr
c.e.carr@qmul.ac.uk
Contact information
Scientific
Unit for Social and Community Psychiatry
Newham Centre for Mental Health
Glen Road
London
E13 8SP
United Kingdom
 ORCID ID |
0000-0001-5179-2464 |
|---|---|
| Phone | +44 20 7540 4380 Ext. 2315 |
| c.e.carr@qmul.ac.uk |
Study information
| Study design | Randomised; Both; Design type: Treatment, Psychological & Behavioural, Qualitative |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Feasibility study for a randomised controlled trial of intensive group music therapy for acute adult psychiatric inpatients (F-IGMT) |
| Study acronym | F-IGMT |
| Study objectives | The aim of this study is to assess the feasibility of conducting a larger effectiveness study of music therapy in reducing mental illness symptoms. |
| Ethics approval(s) | London- Fulham Research Ethics Committee, 30/03/2017, ref: 17/LO/0505 |
| Health condition(s) or problem(s) studied | Specialty: Mental Health, Primary sub-specialty: Study not assigned to a MH Clinical Studies Group; UKCRC code/ Disease: Mental Health/ Unspecified mental disorder |
| Intervention | Stage 1: Participants are randomised individually to receive music therapy or treatment as usual in a 2:1 ratio. Music therapy: Participants receive off-ward group music therapy, 60 minutes, 4 times per week for up to 4 weeks Treatment as usual: Participants receive all other medical and therapeutic care offered within the hospital In both groups, participants undergo follow up assessments at two and four weeks and three and six months, with an optional semi-structured interview at four weeks. Stage 2: Simulation of cluster randomisation comparing one ward with music therapy input to one ward without. Music therapy ward: Participants receive on-ward group music therapy, 60 minutes, 3 times per week for up to 4 weeks Control ward: Participants receive all other medical and therapeutic care offered within the hospital. In both groups, participants undergo follow up assessments at two and four weeks and three and six months, with an optional semi-structured interview at four weeks. |
| Intervention type | Other |
| Primary outcome measure | Feasibility outcomes: 1. Recruitment rate is recorded as the number of eligible participants who consent to participate in the study by 10 weeks 2. Participation rate is recorded as the proportion of eligible participants who consent to participate by 10 weeks. 3. Retention rate is recorded as the number of participants who consent to participate that remain in the study until the end of follow up at 6 months 4. Compliance rate is recorded as the number of participants allocated to the intervention arm who attend 10 or more sessions of music therapy within 4 week treatment period |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/04/2016 |
| Completion date | 31/08/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 60; UK Sample Size: 60 |
| Key inclusion criteria | 1. Adults aged 18 or above, any gender, admitted to and receiving treatment on an acute psychiatric ward 2. Willingness to receive group music therapy or treatment as usual 3. Willingness to be randomised to group music therapy or treatment as usual (stage 1, off-ward recruitment only) 4. Capacity to give informed consent 5. Sufficient English language comprehension to complete measures, or access to assistance from an interpreter |
| Key exclusion criteria | 1. Presence of an organic mental disorder 2. Insufficient language comprehension and no available interpreter 3. No capacity to give informed consent (monitoring of capacity will occur throughout) |
| Date of first enrolment | 10/04/2017 |
| Date of final enrolment | 07/08/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
London
E13 8SP
United Kingdom
London
E1 4DG
United Kingdom
Sponsor information
University/education
Joint Research Management Office
5 Walden Street
London
E1 2EF
England
United Kingdom
| Phone | +44 20 7882 7260 |
|---|---|
| sponsorsrep@bartshealth.nhs.uk | |
"ROR" |
https://ror.org/026zzn846 |
Funders
Funder type
Government
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 | 31/08/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | 1. Planned publication in a high-impact peer reviewed open access journal 2. Dissemination of findings to study participants and carers 3. Dissemination to local NHS Trusts, professional bodies and charities |
| IPD sharing plan | The current data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Other files | End of study Summary | 27/05/2025 | 27/05/2025 | No | No |
| Protocol file | version 5 | 03/03/2017 | 27/05/2025 | No | No |
Additional files
Editorial Notes
27/05/2025: The following changes were made to the trial record:
1. Uploaded protocol (not peer-reviewed) as an additional file.
2. A file containing a summary of results was added.
