社交隔离时期针对产后抑郁症的在线歌唱干预：SHAPER-PNDO单臂试验的可行性研究方案

Online singing interventions for postnatal depression in times of social isolation: a feasibility study protocol for the SHAPER-PNDO single-arm trial.

作者信息

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

机构信息

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

Department of Behavioural Science and Health, University College London, Gower Street, London, WC1E 6BT, UK.

出版信息

Pilot Feasibility Stud. 2022 Jul 18;8(1):148. doi: 10.1186/s40814-022-01112-1.

DOI:10.1186/s40814-022-01112-1

PMID:35851430

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9289358/

Abstract

BACKGROUND

Postnatal depression (PND) affects 13% of new mothers, with numbers rising during the COVID-19 pandemic. Despite this prevalence, many women have difficulty with or hesitancy towards accessing pharmacological and/or psychological interventions. Group-based mother-baby activities, however, have a good uptake, with singing improving maternal mental health and the mother-infant relationship. The recent lockdowns highlight the importance of adapting activities to an online platform that is wide-reaching and accessible.

AIMS

The SHAPER-PNDO study will primarily analyse the feasibility of a 6-week online singing intervention, Melodies for Mums (M4M), for mothers with PND who are experiencing barriers to treatment. The secondary aim of the SHAPER-PNDO study will be to analyse the clinical efficacy of the 6-week M4M intervention for symptoms of postnatal depression.

METHODS

A total of 120 mothers and their babies will be recruited for this single-arm study. All dyads will attend 6 weekly online singing sessions, facilitated by Breathe Arts Health Research. Assessments will be conducted on Zoom at baseline and week 6, with follow-ups at weeks 16 and 32, and will contain interviews for demographics, mental health, and social circumstances, and biological samples will be taken for stress markers. Qualitative interviews will be undertaken to understand the experiences of women attending the sessions and the facilitators delivering them. Finally, data will be collected on recruitment, study uptake and attendance of the programme, participant retention, and acceptability of the intervention.

DISCUSSION

The SHAPER-PNDO study will focus on the feasibility, alongside the clinical efficacy, of an online delivery of M4M, available to all mothers with PND. We hope to provide a more accessible, effective treatment option for mothers with PND that can be available both during and outside of the pandemic for mothers who would otherwise struggle to attend in-person sessions, as well as to prepare for a subsequent hybrid RCT.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT04857593 . Registered retrospectively on 22 April 2021. The first participants were recruited on 27 January 2021, and the trial is ongoing.

摘要

背景

产后抑郁症（PND）影响着13%的新妈妈，在新冠疫情期间这一数字有所上升。尽管患病率如此之高，但许多女性在获得药物和/或心理干预方面存在困难或犹豫不决。然而，基于群体的母婴活动参与度较高，唱歌能改善产妇心理健康及母婴关系。近期的封锁凸显了将活动适配到覆盖面广且易于使用的在线平台的重要性。

目的

SHAPER-PNDO研究将主要分析为期6周的在线唱歌干预“妈妈的旋律”（M4M）对存在治疗障碍的产后抑郁症母亲的可行性。SHAPER-PNDO研究的次要目的是分析为期6周的M4M干预对产后抑郁症状的临床疗效。

方法

本单臂研究将招募120对母婴。所有母婴对将参加由呼吸艺术健康研究组织主持的每周一次、为期6周的在线唱歌课程。评估将在基线时和第6周在Zoom上进行，在第16周和第32周进行随访，评估内容包括人口统计学、心理健康和社会情况的访谈，并采集生物样本以检测压力指标。将进行定性访谈以了解参加课程的女性及授课人员的体验。最后，将收集关于该项目的招募、参与情况和出勤、参与者留存率以及干预可接受性的数据。