Feasibility and acceptability of group music therapy vs wait-list control for treatment of patients with long-term depression (the SYNCHRONY trial): study protocol for a randomised controlled trial

Catherine Elizabeth Carr, Julian O'Kelly, Stephen Sandford, Stefan Priebe, Catherine Elizabeth Carr, Julian O'Kelly, Stephen Sandford, Stefan Priebe

Abstract

Background: Depression is of significant global concern. Despite a range of effective treatment options it is estimated that around one in five diagnosed with an acute depressive episode continue to experience enduring symptoms for more than 2 years. There is evidence for effectiveness of individual music therapy for depression. However, no studies have as yet looked at a group intervention within an NHS context. This study aims to assess the feasibility of conducting a randomised controlled trial of group music therapy for patients with long-term depression (symptom durations of 1 year or longer) within the community.

Methods: This is a single-centre randomised controlled feasibility trial of group music therapy versus wait-list control with a nested process evaluation. Thirty participants will be randomised with unbalanced allocation (20 to receive the intervention immediately, 10 as wait-list controls). Group music therapy will be offered three times per week in a community centre with a focus on songwriting. Data will be collected post-intervention, 3 and 6 months after the intervention finishes. We will examine the feasibility of recruitment processes including identifying the number of eligible participants, participation and retention rates and the intervention in terms of testing components, measuring adherence and estimation of the likely intervention effect. A nested process evaluation will consist of treatment fidelity analysis, exploratory analysis of process measures and end-of-participation interviews with participants and referring staff.

Discussion: Whilst group music therapy is an option in some community mental health settings, this will be the first study to examine group music therapy for this particular patient group. We will assess symptoms of depression, acceptability of the intervention and quality of life. We anticipate potential challenges in the recruitment and retention of participants. It is unclear whether offering the intervention three times per week will be acceptable to participants, particularly given participants' enduring symptoms and impact upon motivation. This study will provide data to inform both development of the intervention and to assess and inform the design of a full trial.

Trial registration: ISRCTN.com, ISRCTN18164037 . Registered on 26 September 2016.

Keywords: Chronic depression; Feasibility; Group music therapy; Nested process evaluation; Randomised controlled trial; Songwriting.

Figures

Fig. 1
Fig. 1
Flow diagram of the SYNCHRONY study to assess the feasibility of group music therapy for chronic depression. BDI-II Beck Depression Inventory-II, CSO Clinical Studies Officers, GP general practice, IAPT Improving Access to Psychological Therapies, MADRS Montgomery-Åsberg Depression Rating Scale, MT Music Therapists, PICs Participant Identification Centres, RA Research Assistant, SU-R Service-User Researcher
Fig. 2
Fig. 2
Standard Protocol Items: Recommendation for Interventional Trials (SPIRIT) diagram of assessments at enrolment, allocation, 3-weekly sessions, post-intervention, 3-month and 6-month time points. aAdministered in the intervention group only. bRated pre-session and post-session. BDI-II Beck Depression Inventory-II, CSQ Client Satisfaction Questionnaire, CSRI Client Services Receipt Inventory, DMS Dimensional Mood Scale, GPSES General Perceived Self-efficacy Scale, IIM Interest in Music Scale [95], LSP Life Skills Profile, MADRS Montgomery-Åsberg Depression Rating Scale, MANSA Manchester Short Quality of Life Scale, RSES Rosenberg Self-esteem Scale, RSS Relationship Satisfaction Scale, WSAS Work and Social Adjustment Scale

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