Group music therapy with songwriting for adult patients with long-term depression (SYNCHRONY study): a feasibility and acceptability study of the intervention and parallel randomised controlled trial design with wait-list control and nested process evaluation.

Background: Despite effective treatments, one fifth of patients develop chronic depression. Music therapy may offer a different approach. This study aimed to assess feasibility and acceptability of a music therapy intervention and trial methodology.

Methods: A parallel two-arm randomised controlled trial with wait-list control, mixed feasibility/acceptability measures and nested process evaluation. Adults with long-term depression (symptom duration > 1 year) were recruited from community mental health services and computer randomised to 42 sessions of group music therapy with songwriting three times per week or wait-list control. Depression, social functioning, distress, quality of life, satisfaction and service use were assessed by blinded researchers at enrolment, 1 week and 3 and 6 months post-therapy. Outcomes were analysed descriptively, controlling for baseline covariates. Recruitment (number eligible, participation and retention rates) and intervention (fidelity, adherence) feasibility were assessed using pre-defined stop-go criteria. Attendance, adverse events, mood, relationship satisfaction and semi-structured interviews were analysed in a nested process evaluation.

Results: Recruitment processes were feasible with 421 eligible, 12.7% participation and 60% (18/30) retention. Thirty participants were randomised to intervention (N = 20) and control (N = 10). Session attendance was low (mean 10.5) with four withdrawals. Music therapist adherence was good but changes to session frequency were suggested. Outcomes were available for 10/20 treatment and 9/10 wait-list participants. Depression increased in both arms post-therapy. Treatment depression scores fell below baseline 3 and 6 months post-therapy indicating improvement. Wait-list depression scores increased from baseline 3 and 6 months post-therapy. At 3 months, the treatment arm improved from baseline on all measures except satisfaction and functioning. At 6 months, quality of life, distress and functioning improved with reduction in health service contacts. High-attending participants improved more than low-attending. Seven adverse events (one serious) were reported.

Limitations: As this was a feasibility study, clinical outcomes should be interpreted cautiously.

Conclusion: A randomised controlled trial of group music therapy using songwriting is feasible with inclusion criteria and session frequency modifications, but further intervention development is required.

Trial Registration: ISRCTN18164037 on 26.09.2016.