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针对成年长期抑郁症患者的集体音乐疗法与歌曲创作(同步研究):干预措施的可行性与可接受性研究以及采用等待名单对照和嵌套式过程评估的平行随机对照试验设计

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.

作者信息

Carr Catherine Elizabeth, Millard Emma, Dilgul Merve, Bent Cornelia, Wetherick Donald, French Jennifer, Priebe Stefan

机构信息

Unit for Social and Community Psychiatry, WHO Collaborating Centre for Mental Health Services Development, Centre for Psychiatry and Mental Health, Wolfson Institute of Population Health, Queen Mary University of London, Newham Centre for Mental Health, Glen Road, London, E13 8SP, UK.

East London NHS Foundation Trust, Trust Headquarters, Robert Dolan House, 9 Alie Street, London, E1 8DE, UK.

出版信息

Pilot Feasibility Stud. 2023 May 5;9(1):75. doi: 10.1186/s40814-023-01285-3.

DOI:10.1186/s40814-023-01285-3
PMID:37147699
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10161457/
Abstract

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.

摘要

背景

尽管有有效的治疗方法,但仍有五分之一的患者会发展为慢性抑郁症。音乐疗法可能提供一种不同的方法。本研究旨在评估音乐疗法干预措施及试验方法的可行性和可接受性。

方法

一项采用等待名单对照的平行双臂随机对照试验,混合了可行性/可接受性测量和嵌套式过程评估。从社区精神卫生服务机构招募患有长期抑郁症(症状持续时间>1年)的成年人,并通过计算机随机分为接受每周三次歌曲创作的42节集体音乐疗法组或等待名单对照组。在入组时、治疗后1周、3个月和6个月,由不知情的研究人员评估抑郁、社会功能、痛苦、生活质量、满意度和服务使用情况。对结果进行描述性分析,并对基线协变量进行控制。使用预先定义的继续/停止标准评估招募(符合条件的人数、参与率和保留率)和干预(保真度、依从性)的可行性。在嵌套式过程评估中分析出勤率、不良事件、情绪、关系满意度和半结构化访谈。

结果

招募过程可行,有421人符合条件,参与率为12.7%,保留率为60%(18/30)。30名参与者被随机分为干预组(N = 20)和对照组(N = 10)。课程出勤率较低(平均10.5节),有4人退出。音乐治疗师的依从性良好,但建议改变课程频率。10/20名治疗组参与者和9/10名等待名单组参与者有结果数据。治疗后两组的抑郁症状均有所增加。治疗组的抑郁评分在治疗后3个月和6个月低于基线,表明有所改善。等待名单组的抑郁评分在治疗后3个月和6个月从基线开始上升。在3个月时,治疗组除满意度和功能外,所有指标均较基线有所改善。在6个月时,生活质量、痛苦程度和功能有所改善,医疗服务接触减少。高出勤率的参与者比低出勤率的参与者改善更多。报告了7起不良事件(1起严重)。

局限性

由于这是一项可行性研究,临床结果应谨慎解读。

结论

采用歌曲创作的集体音乐疗法随机对照试验在修改纳入标准和课程频率后是可行的,但需要进一步开发干预措施。

试验注册

2016年9月26日ISRCTN18164037。

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