Condition category
Mental and Behavioural Disorders
Date applied
03/04/2017
Date assigned
04/04/2017
Last edited
04/04/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

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
Glen Road
London
E13 8SP
United Kingdom
+44 20 7540 4380 Ext. 2315
c.e.carr@qmul.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

34200

Study information

Scientific title

Feasibility study for a randomised controlled trial of intensive group music therapy for acute adult psychiatric inpatients (F-IGMT)

Acronym

F-IGMT

Study hypothesis

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

London- Fulham Research Ethics Committee, 30/03/2017, ref: 17/LO/0505

Study design

Randomised; Both; Design type: Treatment, Psychological & Behavioural, Qualitative

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/04/2016

Overall trial end date

31/08/2018

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 60; UK Sample Size: 60

Participant 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)

Recruitment start date

10/04/2017

Recruitment end date

07/08/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Newham Centre for Mental Health
Glen Road
London
E13 8SP
United Kingdom

Trial participating centre

Tower Hamlets Centre for Mental Health
Bancroft Road
London
E1 4DG
United Kingdom

Sponsor information

Organisation

Queen Mary University of London

Sponsor details

Joint Research Management Office
5 Walden Street
London
E1 2EF
United Kingdom
+44 20 7882 7260
sponsorsrep@bartshealth.nhs.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

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.

Intention to publish date

31/08/2019

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes