Condition category
Mental and Behavioural Disorders
Date applied
26/09/2016
Date assigned
26/09/2016
Last edited
29/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

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 song-writing 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 Julian O’Kelly
Julian.Okelly@elft.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Julian O'Kelly

ORCID ID

http://orcid.org/0000-0002-4356-0564

Contact details

Newham Centre for Mental Health
Glen Road
London
E13 8SP
United Kingdom
+44 20 7540 4380 Ext 2315
Julian.Okelly@elft.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

31529

Study information

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

Acronym

SYNCHRONY

Study hypothesis

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

Wales Research Ethics Committee 2, 13/09/2016, ref: 16/WA/0248

Study design

Randomised; Interventional; Design type: Treatment, Psychological & Behavioural

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 the contact details below to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

01/04/2016

Overall trial end date

30/09/2017

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 30; UK Sample Size: 30

Participant 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

Recruitment start date

01/10/2016

Recruitment end date

30/11/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

East London NHS Foundation Trust (Noclor)

Sponsor details

1st Floor
Bloomsbury Building
St Pancras Hospital
4 St Pancras Way
London
NW1 0PE
United Kingdom

Sponsor type

Hospital/treatment centre

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

The CI, co-applicants and Service User Lead will consult with each other as to a strategy for dissemination, and will at all times ensure they meet the standards required for submission to high quality peer reviewed journals etc. Data arising from the trial will be owned by the Unit for Social and Community Psychiatry. On completion of the trial, the final data will be analysed and tabulated and a Final Study Report prepared. Participants will be informed of the results of the study via a specifically designed newsletter. Participants may request specific results relating to their participation from the CI or Trial Co-ordinator once the study results have been published and members of the TMG are un-blinded.

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

30/09/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

29/09/2016: Verified study information with principal investigator.