Yoga-based lifestyle intervention for antenatal depression (YOGA-D): study protocol for a pilot randomized controlled trial

Wellcome Open Res. 2024 Nov 6:9:326. doi: 10.12688/wellcomeopenres.22493.2. eCollection 2024.

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.

Registration: CTRI ( CTRI/2024/05/067176; 10/05/2024).

Keywords: Depression; India; Preganancy; Yoga.

Plain language summary

Pregnancy is not always a positive experience for all women. Some of them suffer from depression during pregnancy. This has negative impact on the health of an expectant mother, can lead to premature delivery, depression after pregnancy, and affects growth and weight of the fetus. Although women experience symptoms of depression, neither they are aware of this mental health condition, nor do they know what exactly needs to be done for the same. Anti-depressant drugs and ‘talk-therapies’ can be helpful, but the former may have adverse impact on fetal development and the latter is not widely available especially in rural settings in India. In this scenario, yoga practiced during pregnancy can be a potential solution. Women can practice yoga with minimal training, and it may have beneficial effects on depression during pregnancy. Through this study titled, ‘YOGA-based lifestyle intervention for Antenatal Depression (YOGA-D), our aim is to find out if it is possible for us to teach yoga to pregnant women in a rural setting in Maharashtra, India. Is yoga acceptable to them, will they practice yoga as per the plan we have finalized, and if they practice yoga regularly what effect will it have on their depression scores after three months of yoga practice and depression after delivery. YOGA-D is an experimental study where in half of the eligible women will be requested to practice yoga and the rest will continue with their routine care. Selection of the women in yoga group will be done randomly. Adult women (age>18 years) between 12 and 26 weeks of pregnancy, and who do not have any medical or pregnancy related problems are eligible to participate in the study. Depression will be measured using the Marathi version of the Patient Health Questionnaire-9. Stress, anxiety, and quality of life will also be measured.

Associated data

  • figshare/10.6084/m9.figshare.25866205

Grants and funding

This work was supported by The Wellcome Trust-DBT India Alliance [IA/CPHI/20/1/505274].