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英国一项针对产后抑郁症的在线歌唱干预的可行性、临床疗效及幸福感结局:SHAPER-PNDO,一项单臂临床试验

Feasibility, clinical efficacy, and well-being outcomes of an online singing intervention for postnatal depression in the UK: SHAPER-PNDO, a single-arm clinical trial.

作者信息

Bind Rebecca H, Sawyer Kristi, Hazelgrove Katie, Rebecchini Lavinia, Miller Celeste, Ahmed Subeyda, Dazzan Paola, Sevdalis Nick, Bakolis Ioannis, Davis Rachel, Lopez Maria Baldellou, Woods Anthony, Crane Nikki, Manoharan Manonmani, Burton Alexandra, Dye Hannah, Osborn Tim, Greenwood Lorna, Perkins Rosie, Fancourt Daisy, Pariante Carmine M, Estevao Carolina

机构信息

Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 5 Cutcombe Rd, Brixton, London, SE5 9RT, UK.

Centre for Implementation Science, Health Service and Population Research Department, Institute of Psychiatry, Psychology & Neuroscience, 16 De Crespigny Park, London, SE5 8AB, UK.

出版信息

Pilot Feasibility Stud. 2023 Jul 27;9(1):131. doi: 10.1186/s40814-023-01360-9.

DOI:10.1186/s40814-023-01360-9
PMID:37501172
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10373337/
Abstract

BACKGROUND

Postnatal depression (PND) affects over 12% of mothers, with numbers rising during COVID-19. Singing groups can support mothers with PND; however, online delivery has never been evaluated. SHAPER-PNDO, a single-arm clinical trial, evaluated the feasibility, clinical efficacy, and well-being outcomes of a 6-week online version of Breathe Melodies for Mums (M4M) singing intervention developed for mothers with PND during COVID-19 lockdowns.

METHODS

The primary objective of this study was to assess the feasibility of a group online singing intervention for new mothers with postnatal depression. This was ascertained through recruitment rates, study retention rates, attendance rates to the singing sessions, and study completion rates. The secondary objective of the study was to assess the clinical efficacy and well-being outcomes of the singing intervention. Specifically, we measured change in Edinburgh Postnatal Depression Scale (EPDS), State-Trait Anxiety Inventory (STAI), Perceived Stress Scale (PSS), and Office for National Statistics Wellbeing Scale (ONS) scores from baseline to end-of-intervention (week 6); follow-up assessments were completed at weeks 3, 16, and 32. Mothers were eligible if they scored ≥10 on the baseline EPDS.

RESULTS

Eighty-seven percent of the 37 recruited mothers completed the study, attending, on average, 5 of the 6 group singing sessions. With regard to secondary outcomes, at end-of-treatment, mothers experienced significant reductions in depression (EPDS, 16.6 ± 3.7 to 11.2 ± 5.3, 95% CI [0.79,1.65]), anxiety (STAI-S, 48.4 ± 27.1 to 41.7 ± 26.8, 95% CI [4.96, 17.65]) and stress (PSS, 29.0 ± 5.7 to 19.7 ± 5.3, 95% CI [1.33, 7.07]); and, furthermore, significant improvements in life satisfaction (ONS, 50.5 ± 23.0 to 72.8 ± 11.7, 95% CI [- 39.86, - 4.64]) and feelings of worthwhileness (ONS, 51.7 ± 30.4 to 78.6 ± 15.1, 95% CI [- 52.79, - 0.85]). Reduction on the EPDS correlated with a reduction on the BDI and the STAI-S and maternal childhood maltreatment was predictive of a smaller treatment response.

CONCLUSIONS

M4M online was feasible to mothers who partook in the programme. Furthermore, M4M online supports the mental health and well-being of new mothers experiencing PND, especially when barriers to in-person treatment are present.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04857593 . Registered 22 April 2021, retrospectively registered.

摘要

背景

产后抑郁症(PND)影响超过12%的母亲,在新冠疫情期间这一数字有所上升。歌唱小组可以为患有产后抑郁症的母亲提供支持;然而,在线授课方式从未经过评估。SHAPER-PNDO是一项单臂临床试验,评估了在新冠疫情封锁期间为患有产后抑郁症的母亲开发的为期6周的在线版“妈妈的呼吸旋律”(M4M)歌唱干预的可行性、临床疗效和幸福感结果。

方法

本研究的主要目标是评估针对患有产后抑郁症的新妈妈进行小组在线歌唱干预的可行性。这通过招募率、研究保留率、歌唱课程的出勤率和研究完成率来确定。该研究的次要目标是评估歌唱干预的临床疗效和幸福感结果。具体而言,我们测量了从基线到干预结束(第6周)爱丁堡产后抑郁量表(EPDS)、状态-特质焦虑量表(STAI)、感知压力量表(PSS)和英国国家统计局幸福感量表(ONS)得分的变化;在第3周、第16周和第32周完成了随访评估。如果母亲在基线EPDS上的得分≥10分,则符合条件。

结果

37名招募的母亲中有87%完成了研究,平均参加了6次小组歌唱课程中的5次。关于次要结果,在治疗结束时,母亲们的抑郁(EPDS,16.6±3.7至11.2±5.3,95%CI[0.79,1.65])、焦虑(STAI-S,48.4±27.1至41.7±26.8,95%CI[4.96,17.65])和压力(PSS,29.0±5.7至19.7±5.3,95%CI[1.33,7.07])显著降低;此外,生活满意度(ONS,50.5±23.0至72.8±11.7,95%CI[-39.86,-4.64])和价值感(ONS,51.7±30.4至78.6±15.1,95%CI[-52.79,-0.85])有显著改善。EPDS得分的降低与BDI和STAI-S得分的降低相关,母亲童年期受虐待可预测治疗反应较小。

结论

M4M在线课程对参与该项目的母亲来说是可行的。此外,M4M在线课程有助于改善患有产后抑郁症的新妈妈的心理健康和幸福感,尤其是在存在面对面治疗障碍的情况下。

试验注册

ClinicalTrials.gov NCT04857593。2021年4月22日注册,追溯注册。

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