Psychosocial Intervention to Improve Mental Health of Abused Pregnant Women: A Randomized-Controlled Pilot Trial

Background: Domestic and family violence (DFV) during pregnancy has been identified as a significant global health issue, with the higher magnitude and severity noted in developing countries. [1, 2] The strong correlation between domestic and family violence (DFV) and mental health has been well documented in studies. [2] Pregnancy is a period when both DFV and mental distress tend to occur and/or accentuate. [3] The World Health Organization (WHO) and Centre for Disease Control and Prevention (CDC) have considered these intersecting issues —DV and mental health— as major targets for prevention and intervention.[4] Although limited, available evidence from developed settings has shown beneficial effects of continual support and education on reducing DFV and improving mental health. [5, 6] Streamlining interventions for mental health and DFV within antenatal care (ANC) is likely to increase service accessibility, and reduce treatment gaps and stigma. [7] Counselling interventions delivered within antenatal settings which emphasized empathetic listening and improving access of support services were found to have shown positive impacts on reducing DV and psychological distress and improving adoption of safety behaviours among pregnant women. [8, 9] However, there exists a substantial gap in knowledge and awareness regarding effective interventions for DFV, particularly in resource-constrained settings. Hence, a two-arm parallel randomised trial was designed to assess the effectiveness of a counselling based psychosocial intervention on the emotional wellbeing of abused pregnant women.

Methods and analysis: The study is being conducted in an antenatal clinic of a tertiary hospital located in Eastern part of Nepal. Pregnant women were included in the study if they met the following inclusion criteria; i) 24-34 weeks of gestation; ii) a history of DFV; iii) access to a telephone; and, iii) can read and understand Nepali language.

The intervention was developed through extensive bibliographic reviews and expert consultation. The pregnant women who were randomly allocated to the intervention group received a psychosocial intervention, which consisted of three interactive components: i) one-to-one supportive counselling; ii) an information booklet; and iii) telephone support (for the duration of the study). While, the women in the control group received standard care and contact details of referral services. The development and validation of the information booklet were carried out based on the recommendations by Echer. [10] The validation of the booklet involved two phases; first, experts were asked to evaluate the booklet using a four-point Likert scale, and second, pregnant women who met the inclusion criteria were asked a set of questions related to the organization, structure and presentation of the booklet. The percentage of agreement and content validity index were calculated to assess the validity of the booklet.

The primary endpoints of this study is mental wellbeing, which was measured using standard and validated Hospital Anxiety and Depression Scale (HADS). [11] The secondary endpoints are quality of life, and use of safety behaviours, social support and community resources. The trial is registered in Australian New Zealand Clinical Trial Registry (ANZCTRN) 1261800030702, (1 March, 2018). Ethical approval has been obtained from the Griffith University Human Research Ethics Committee and the Nepal Health Research Council.

Baseline data collection and intervention delivery has been completed and follow-up interviews are ongoing. Follow-up interviews will be conducted twice; once at 4 weeks following the intervention and, another at 6 weeks following the birth of the baby. Descriptive statistics will be used to assess the feasibility of the study and the characteristics of the participants. The study outcomes will be compared across and within the groups using independent t-test and Analysis of Covariance (ANCOVA) respectively. Modified Intention-to-treat (ITT) analysis will be carried out to include the missing data. Qualitative feedback regarding acceptability, suitability and utility of the program will be collected from participants allocated to the intervention group during their follow-up visits. In addition, strengths and weakness of the intervention and recommendations to improve the intervention in future will be sought from semi-structured interviews with health care providers.

Results: The validation of the booklet yielded satisfying Content Validity Index (CVI). i.e. >0.78. Overall, 623 women were screened during three months recruitment time (June to August, 2018). Total 140 women met the inclusion criteria and consented to participate in the intervention. The women were randomly allocated into the intervention or control group using block randomization. Follow-up interviews are being carried out and data analysis will commence after completion of these interviews.

Discussion: This is a robustly designed trial which intends to provide evidence on impact of a brief single session counselling intervention on mental health of pregnant women having history of abuse. This study is the first of its kind in Nepal. By testing the feasibility, applicability and efficacy of a piloted intervention, this study can provide valuable insights for program planners and policy makers and guide future researchers. The findings will be published in journals and presented in national and international conferences.