Trial design, setting, and participants

The study was a randomised controlled trial (RCT) with two groups (intervention and control) among pregnant women experiencing DV. The study was conducted from January 2019 to June 2020 at a tertiary-care LN hospital in New Delhi. The study was approved by the institutional review board of the National Institute of Health and Family Welfare (NIHFW), New Delhi. Since the respondents are the patients of the hospital, ethical compliance was obtained from the Ethical Committee of MAMC, New Delhi. The LN hospital is a government hospital that provides free services and caters to people of low and middle socio-economic status.

The inclusion criteria comprised all married pregnant women (preferably between 18 and 20 weeks of pregnancy) attending the obstetrics OPD of LN hospital for antenatal registration; in the age group of 18–37 years, primigravida and multigravida were considered. Further, having been screened positive for DV during the year using the Abuse Assessment Screening Tool (AAST) [23], continuing to stay with the husband or in-laws (family) for at least two years, being likely to continue the treatment till delivery, and being willing to come to the hospital for follow-up as per schedule were other inclusion criteria. Consent was sought for participation in the study by taking signatures on the informed consent form. Women excluded from this study were those who had already been registered as medicolegal cases (MLCs) related to abuse, those who were in a high-risk group (conditions that may pose a risk to the pregnancy), and those who were intellectually challenged to comprehend and comply with the intervention.

Intervention

A study was carried out in 2016 to assess the feasibility of the behavioural intervention package (BIP) [24], which was then applied in the study. The BIP and standard care were administered to each woman in the intervention group. The control group did not receive the BIP. Standard care was provided alone. The BIP consisted of five components focusing on (i) understanding the depth of the problem and assessing the need with empathy and rapport; (ii) analysing her strengths and available resources (emotional, medical, and physical resources) for utilization and navigating a better outcome; (iii) self-regulation mechanisms of the internal system of the body through yoga-based methods (chanting, meditation, and exercise); (iv) individual counselling for effective communication and better interpersonal relations; and (v) developing better awareness for safety planning, problem-solving, and creating opportunities for alternate livelihoods. The standard of care focused on the routine care provided by the health professional at the antenatal clinic includes antenatal care (ANC), postnatal care (PNC), and child care components. It also includes promoting health and well-being via education and support for nutrition, substance abuse cessation, family planning uptake, recognition of danger signs, birth preparedness, etc. The standard care intervention was given to each woman in both groups. The interaction and discussion focused on healthy development and the well-being of the foetus and mother. Although it is part of routine care, the research team reiterated this information in individual-centered care.

The intervention was administered by senior researchers trained in clinical psychology, community medicine, gynaecology, anthropology, and yoga. The sessions were held periodically and distributed over 11 months. Each one-to-one session for administering the intervention package lasted about 45–70 min in an excluded room near OPD without the male partner or other family members being present. After each intervention session, the woman was given the next session’s time and date. The entire intervention package was administered, i.e. 6 weeks postnatal, and 11 sessions were conducted with each woman over 28 weeks. The control group received the standard care intervention, which consisted of 11 sessions with the researcher, similar to the study group. Participants were reimbursed for their travel expenses per ICMR guidelines [25] after each session to comply with ethical issues and ensure compliance. A qualitative study was carried out, which helped to identify outcomes most valued by participants and explore barriers and facilitators to adherence to the intervention [26].

Study outcomes

The primary outcome of the present study was QOL measured through a short-form survey (SF-36) [27]. The secondary outcome was the recurrence of DV measured by the Abuse Assessment Screening Tool (AAST) [24]. The outcomes were measured at baseline and post-intervention. Reproductive Child Health (RCH) indicators using the checklist and feedback mechanisms were also recorded to assess the effect of BIP.

Sample size

In a previous study by Tiwari and colleagues [17], an outcome indicator, general health, was considered for sample size calculation. It assumed that the general health is 53 ± 7.5 in the experiment group and 50 ± 7 in the control group; a minor change is expected. It was further, assuming α (type I error) of 5% and power taken as 80%, that a sample of 184 cases was required to be enrolled. It was rounded to hundreds to achieve the figure of 200. Assuming a non-compliance rate of 20%, considering the probability of abortion due to genetic markers and culture-specific reasons for dropouts, the required sample size was 220.

Recruitment and consent

All the pregnant women who met the eligibility criteria were screened using the ASST, and the respondents who answered “yes” within the last year were considered and enrolled in the study. The participants were explained about the study’s purpose, potential risks and benefits, instruments, administration time, and follow-up schedules and approached with the subject information sheet (SIS) for consent. If a participant agreed to participate, written informed consent was obtained, and the participant was enrolled in the study.

Randomisation and blinding

To avoid any bias in selection, eligible participants were randomised to either the intervention or the control group at a 1:1 ratio. The list was generated by a computer, concealed in consecutively numbered, sealed envelopes, and recorded by an investigator who was not involved in the study. Outcome assessors and research assistants who entered and analysed the data were recruited after data collection in the third phase and, therefore, did not know the study hypotheses or design and were blinded to group assignment. The person administering the intervention and standard care packages differed for the groups and were not interchangeable.

Questionnaire measures and data collection tools

The Socio-Economic and Demographic Schedule (SEDS), the AAST, the RCH checklist, the SF-36, and the feedback interview schedule were administered to participants of both groups at baseline and post-intervention after the entire intervention had been completed.

1.

The SF-36 is composed of eight multi-item scales (35 items) assessing physical function (PF-10 items), role physical (RP-4 items), bodily pain (BP-2 items), general health (GH-5 items), vitality (VT-4 items), social functioning (SF-2 items), role emotional (RE-3 items), and mental health (MH-5 items) [27].

2.

The ASST, which has 15 items developed and validated in Indian culture, was used to screen. A comprehensive assessment tool for DV, having 43 items, was used to evaluate the type, frequency, duration, abuser-relationship fabric, and severity of violence [23].

3.

Reproductive Child Health Checklist- Based on OPD investigation information, an RCH checklist on reproductive and child health was used. Maternal health data was related to the pregnancy duration, pregnancy outcome, and sex of the children. The current reproductive health status of the women included their height and weight, planned and unplanned pregnancies, haemoglobin (Hb), blood pressure (BP), preterm labour, hypertensive disorders, drug use, premature rupture of membranes, intrauterine growth retardation, and intrauterine death (IUD) of the foetus, as well as the child’s sex. Child health data focused on the baby’s birth weight and immunization per the national immunization schedule [24].

4.

Socio-Economic and Demographic Schedule (SEDS): The schedule includes information regarding age, education, caste, religion, family type, and income.

5.

Feedback on BIP: The research team collected feedback using a semi-structured interview schedule covering all five domains of the BIP, including safety planning, problem-solving, daily yoga practice, maintenance of a diet chart, and coping mechanisms. Some questions were asked to be maintained daily in charts/handouts, some quarterly in open-ended responses, and a few on completing the intervention using a 5-point Likert scale [24].

The researcher telephoned the respondent twice, two days before and a day before, to remind her of the date and time for the follow-up session to enhance her participation. If the participant could not come to the hospital for some reason, the researcher fixed up another convenient time after discussing it with the participant. It was ensured that the participants got preferential care and respect in the hospital with the facilitation of the investigator. This was not the standard or the norm of the hospital setting. However, it was an essential part of the research study to improve compliance.

Data analysis

Statistical analysis was conducted using SPSS 20 software. The SEDS and RCH indicators were calculated with frequency and chi-square. Data are expressed as frequencies and percentages. Continuous data is represented as the mean ± SD or median (IQR) as appropriate. The severity of DV was compared pre and post-intervention by McNemar test separately for intervention and control groups. Chi-square trend analysis was used to compare trends among the ordinal data separately for pre and post-intervention. An independent t-test/ student t-test was applied to compare continuous normally distributed data, and the Mann-Whitney test (QOL data) was used for non-normal distribution.

Data of the AAST, QOL scale, and their subscales were compared using a paired t-test or Wilcoxon signed test as appropriate (normality/nonnormality) to estimate the effect size (Cohen’s d) at baseline and post-intervention. Besides this, with 95% CI, in terms of (1) between-group differences (primary analysis), (2) within-group change from baseline, and (3) between-group difference in change from baseline in the outcomes. Although 243 women entered the study, baseline information was collected for all. However, for various reasons, 211 respondents completed the intervention session, and therefore, an analysis was conducted on 211.