Group music therapy for chronic depression

ISRCTN	ISRCTN18164037
DOI	https://doi.org/10.1186/ISRCTN18164037
Protocol serial number	31529
Sponsor	East London NHS Foundation Trust (Noclor)
Funder	National Institute for Health Research

Submission date: 26/09/2016
Registration date: 26/09/2016
Last edited: 09/05/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Depression is one of the most common mental disorders worldwide. The symptoms of depression can vary greatly from person to person, but generally include low mood, problems with sleeping and/or eating, and a general loss of interest in life. Chronic depression is a term used for depression that lasts for more than two years. Treating chronic depression is challenging: frequent relapses can be demoralising for patients and carers, and has high healthcare costs. Music therapy aims to support health, using therapeutic relationships and musical activities with verbal reflection. Studies support music therapy for reducing depression symptoms however research is lacking for groups in the NHS. The aim of this study is to find out whether conducting a large study looking at the effectiveness of music therapy for chronic depression is feasible.

Who can participate?
Adults with chronic depression who have been receiving treatment for at least 12 months

What does the study involve?
Participants are randomly allocated to one of two groups. Participants in the first group are invited to a community centre to take part in group music therapy three times a week for 14 weeks. The therapy sessions last for around 90 minutes each and focus on songwriting as a means of supporting well-being. Participants in the second group continue as normal for the duration of the study. At the end of the study period, these participants are offered the group music therapy. All participants complete interviews and questionnaires to assess their symptoms of depression, lifestyle, interest in music and functioning at the start of the study, and 1, 3 and 6 months later. In addition, the investigators access medical records to calculate overall costs of care.

What are the possible benefits and risks of participating?
Given the existing research supporting group and individual music therapy for those with depression in other countries, participants may find group music therapy helpful with the symptoms of depression and general wellbeing. However given this type of research has yet to be conducted in the UK with this type of group we cannot guarantee any such benefits to participation. Participants may benefit in the knowledge that their experiences and views will help us determine how feasible it would be to run a larger study of music therapy and inform us as to what benefits we might wish to measure in this study.
There are not expected to be any major disadvantages or risks to taking part in this study. The main disadvantages are taking time to attend meetings with the researcher and the possibility that participants feel uncomfortable or upset answering questions or that making music could remind them of painful memories.

Where is the study run from?
Newham Centre for Mental Health (UK)

When is the study starting and how long is it expected to run for?
April 2016 to September 2017

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

Dr Catherine Carr
Scientific

Unit for Social and Community Psychiatry
WHO Collaborating Centre for Mental Health Services Development
Queen Mary University of London
Newham Centre for Mental Health
London
E13 8SP
United Kingdom

Phone	+44 (0)20 75404380 Ext 2315
Email	c.e.carr@qmul.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised; Interventional; Design type: Treatment, Psychological & Behavioural
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	StudY oN group music therapy for CHRONic depression: an exploratory pilot to assess feasibilitY of a randomised controlled trial with wait-list control
Study acronym	SYNCHRONY
Study objectives	The aim of this study is to pilot group music therapy for patients with chronic depression and assess the feasibility of conducting a larger randomised controlled trial.
Ethics approval(s)	Wales Research Ethics Committee 2, 13/09/2016, ref: 16/WA/0248
Health condition(s) or problem(s) studied	Specialty: Mental Health, Primary sub-specialty: Depression; UKCRC code/ Disease: Mental Health/ Mood [affective] disorders
Intervention	Participants will be randomised individually with unbalanced allocation to the intervention and control groups (2:1). Intervention group: Participants undertake group music therapy. The treatment will take a songwriting focus and will run for 14 weeks, 3 times per week in a community location. The groups will be run by 2 HCPC registered qualified music therapists. Up to 10 participants will be in each group. Control group: Participants are placed on a waiting list for the duration of the intervention. All study participants will complete interviews and questionnaires to assess their symptoms of depression, lifestyle, interest in music and functioning at the start of the study, and 1, 3 and 6 months later. Follow up interviews will take place at the researcher’s workplace (The Unit for Social and Community Psychiatry), at a Community Mental health Team base in Newham, or a location convenient to the participant
Intervention type	Other
Primary outcome measure(s)	1. Acceptability of methodology to professionals and patients is determined through review of recruitment rates, compliance rates and interviews at 6 months post-intervention 2. Feasibility of recruitment processes is determined through assessing recruitment rate at study end 3. Eligibility, participating and retention rates are measured through screening, recruitment and attendance logs at study end 4. Researcher time and costs per participant is assessed using researcher time diaries at study end 5. Feasibility of the intervention is measured by reviewing attendance rates of participants, use of components by therapists throughout the intervention period of 14 weeks, and adherence to the intervention manual by therapists in the same period 6. Acceptability of the intervention is measured by the estimation of likely intervention effect after 14 weeks, 1, 3 and 6 month follow-ups across the measures of symptoms of: depression, psychological distress, social functioning, self-esteem, self-efficacy, satisfaction with treatment, work and social adjustment, service use and quality of life
Key secondary outcome measure(s)	1. Observer rated depression is measured at baseline, 1, 3 and 6 months post-intervention 2. Self-reported depression is measured at baseline, 1, 3 and 6 months post-intervention 3. Psychological distress is measured at baseline, 1, 3 and 6 months post-intervention 4. Social functioning is measured at baseline, 1, 3 and 6 months post-intervention 5. Self-esteem is measured at baseline, 1, 3 and 6 months post-intervention 6. Self-efficacy is measured at baseline, 1, 3 and 6 months post-intervention 7. Mood is measured using The Dispositional Mood Scale at pre and post session 8. Relationships are measured using Relationship Satisfaction Scale (RSS)(weekly, session 2, pre & post) 9. Satisfaction with treatment is measured at baseline, 1, 3 and 6 months post-intervention 10. Work and social adjustment is measured at baseline, 1, 3 and 6 months post-intervention 11. Hospitalisation is measured at baseline, 1, 3 and 6 months post-intervention 12. Quality of Life is measured at baseline, 1, 3 and 6 months post-intervention
Completion date	30/09/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	30
Total final enrolment	30
Key inclusion criteria	1. Adults aged 18 or above 2. Confirmed diagnosis of depression (ICD10 F31-39, F20.4, F43) 3. Receiving treatment for depression 12 months or longer 4. Capacity to give informed consent
Key exclusion criteria	1. Diagnosis of organic mental disorder (ICD10 F00-09) 2. Bipolar affective disorder- current manic episode 3. No capacity to give informed consent 4. Risk of suicide necessitating hospitalisation
Date of first enrolment	01/10/2016
Date of final enrolment	30/11/2016

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Newham Centre for Mental Health

Glen Road
London
E13 8SP
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
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?
Results article		05/05/2023	09/05/2023	Yes	No
Protocol article	protocol	29/03/2017		Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

09/05/2023: Publication reference added.
28/05/2019: The following changes were made to the trial record:
1. Contact details updated.
2. The total final enrolment number was added.
3. The intention to publish date was changed from 30/09/2018 to 30/09/2019.
22/05/2019: Internal review.
31/03/2017: Publication reference added.