基于瑜伽的产前抑郁生活方式干预（YOGA-D）：一项试点随机对照试验的研究方案
Yoga-based lifestyle intervention for antenatal depression (YOGA-D): study protocol for a pilot randomized controlled trial.
作者信息
Shidhaye Rahul, Bangal Vidyadhar, Bhargav Hemant, Thanage Chitra, Gore Suryabhan, Talole Shamal, Shinde Kalyani, Palande Swapnali, Thete Unnati, Shelke Sonali, Gholap Geeta, Nisal Suchita, Gargade Soni, Tilekar Swanand, Behere Nilam, Game Kalpesh, Murhar Vaibhav, Kunkulol Rahul, Telles Shirley
机构信息
Department of Psychiatry, Pravara Institute of Medical Sciences, Loni, Maharashtra, India.
Department of Health, Ethics and Society, Care and Public Health Research Institute, Maastricht University, Maastricht, Limburg, The Netherlands.
出版信息
Wellcome Open Res. 2024 Nov 6;9:326. doi: 10.12688/wellcomeopenres.22493.2. eCollection 2024.
BACKGROUND
Depression during pregnancy is associated with pre-term labor, low birthweight, post-partum depression and adverse child outcomes. There are concerns about the safety of anti-depressant medications during pregnancy. Many pregnant women with antenatal depression are neither aware about their depression nor do they have access to non-pharmacological interventions for depression. Evidence suggests that pre-natal yoga can improve antenatal depression. Yoga is native to the Indian culture and women can practice yoga as a 'self-care' intervention with minimal training. There is no study till date on the efficacy of yoga on antenatal depression in pregnant women in a low resource (rural) setting in India. This pilot randomized controlled trial aims to study the feasibility, acceptability, and preliminary efficacy of a -based lifestyle intervention for Antenatal epression (YOGA-D) in Maharashtra, India.
METHODS
We will undertake a single-blind individual randomized parallel group-controlled pilot trial with 1:1 allocation ratio. Adult women with 12-26 weeks of pregnancy, without any obstetric or medical complications will be randomly allocated to either the active intervention group (Yoga-Sanskar (YS)) or the Enhanced Usual Care (EUC) group. Trained yoga instructors will teach a pre-defined yoga sequence to the participants in the YS arm. In the EUC arm, participants will receive a single session of health education. We will assess trial feasibility using the recruitment, retention, and study completion rates. The primary outcome of depression will be measured using the translated Marathi version of the Patient Health Questionnaire-9. Assessments will be at the baseline, three-months post-randomization, and post-delivery.
DISCUSSION
This study will help us to understand the barriers in implementation of a yoga-based intervention for antenatal depression in a low-resource/rural setting in Maharashtra, India. Based on the learnings of this pilot trial, we plan to undertake an explanatory randomized controlled trial in the next few months.
REGISTRATION
CTRI ( CTRI/2024/05/067176; 10/05/2024).
背景
孕期抑郁与早产、低出生体重、产后抑郁及不良儿童结局相关。人们担心孕期使用抗抑郁药物的安全性。许多患有产前抑郁的孕妇既未意识到自己的抑郁状况，也无法获得针对抑郁的非药物干预措施。有证据表明，产前瑜伽可改善产前抑郁。瑜伽源自印度文化，女性经过极少的训练就能将其作为一种“自我护理”干预措施来练习。迄今为止，尚无关于印度资源匮乏（农村）地区孕妇瑜伽对产前抑郁疗效的研究。这项试点随机对照试验旨在研究基于瑜伽的生活方式干预对印度马哈拉施特拉邦产前抑郁（YOGA - D）的可行性、可接受性和初步疗效。
方法
我们将进行一项单盲个体随机平行组对照试点试验，分配比例为1:1。怀孕12 - 26周、无任何产科或医学并发症的成年女性将被随机分配至积极干预组（瑜伽 - 桑卡尔（YS）组）或强化常规护理（EUC）组。训练有素的瑜伽教练将向YS组的参与者教授预先确定的瑜伽序列。在EUC组，参与者将接受一次健康教育课程。我们将通过招募率、保留率和研究完成率来评估试验的可行性。抑郁的主要结局将使用患者健康问卷 - 9的马拉地语翻译版本进行测量。评估将在基线、随机分组后三个月和分娩后进行。
讨论
本研究将帮助我们了解在印度马哈拉施特拉邦资源匮乏/农村地区实施基于瑜伽的产前抑郁干预措施的障碍。基于该试点试验的经验教训，我们计划在未来几个月进行一项解释性随机对照试验。
注册信息
CTRI（CTRI/2024/05/067176；2024年5月10日）
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