{"title":"Yoga-based lifestyle intervention for antenatal depression (YOGA-D): study protocol for a pilot randomized controlled trial.","authors":"Rahul Shidhaye, Vidyadhar Bangal, Hemant Bhargav, Chitra Thanage, Suryabhan Gore, Shamal Talole, Kalyani Shinde, Swapnali Palande, Unnati Thete, Sonali Shelke, Geeta Gholap, Suchita Nisal, Soni Gargade, Swanand Tilekar, Nilam Behere, Kalpesh Game, Vaibhav Murhar, Rahul Kunkulol, Shirley Telles","doi":"10.12688/wellcomeopenres.22493.2","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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 <b>YOGA</b>-based lifestyle intervention for Antenatal <b>D</b>epression (YOGA-D) in Maharashtra, India.</p><p><strong>Methods: </strong>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.</p><p><strong>Discussion: </strong>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.</p><p><strong>Registration: </strong>CTRI ( CTRI/2024/05/067176; 10/05/2024).</p>","PeriodicalId":23677,"journal":{"name":"Wellcome Open Research","volume":"9 ","pages":"326"},"PeriodicalIF":0.0000,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11574329/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Wellcome Open Research","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.12688/wellcomeopenres.22493.2","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/1/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"Medicine","Score":null,"Total":0}
引用次数: 0
Abstract
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 YOGA-based lifestyle intervention for Antenatal Depression (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.
Wellcome Open ResearchBiochemistry, Genetics and Molecular Biology-Biochemistry, Genetics and Molecular Biology (all)
CiteScore
5.50
自引率
0.00%
发文量
426
审稿时长
1 weeks
期刊介绍：
Wellcome Open Research publishes scholarly articles reporting any basic scientific, translational and clinical research that has been funded (or co-funded) by Wellcome. Each publication must have at least one author who has been, or still is, a recipient of a Wellcome grant. Articles must be original (not duplications). All research, including clinical trials, systematic reviews, software tools, method articles, and many others, is welcome and will be published irrespective of the perceived level of interest or novelty; confirmatory and negative results, as well as null studies are all suitable. See the full list of article types here. All articles are published using a fully transparent, author-driven model: the authors are solely responsible for the content of their article. Invited peer review takes place openly after publication, and the authors play a crucial role in ensuring that the article is peer-reviewed by independent experts in a timely manner. Articles that pass peer review will be indexed in PubMed and elsewhere. Wellcome Open Research is an Open Research platform: all articles are published open access; the publishing and peer-review processes are fully transparent; and authors are asked to include detailed descriptions of methods and to provide full and easy access to source data underlying the results to improve reproducibility.
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