RESUMEN
OBJECTIVES: A manualised cognitive-behavioural therapy-based psychosocial intervention for prenatal anxiety called Happy Mother Healthy Baby is being tested for its effectiveness through a randomised control trial in Pakistan. The aim of this study was to evaluate the intervention delivery process and the research process. DESIGN: Qualitative methods were used to explore in depth the intervention delivery and research process. SETTING: This process evaluation was embedded within a randomised control trial conducted in a tertiary care facility in Rawalpindi, Pakistan. PARTICIPANTS: Data were collected through in-depth interviews (n=35) with the trial participants and focus group discussions (n=3) with the research staff. Transcripts were analysed using a Framework Analysis. RESULTS: The evaluation of the intervention delivery process indicated that it can be effectively delivered by non-specialist providers trained and supervised by a specialist. The intervention was perceived to be culturally acceptable and appropriately addressing problems related to prenatal anxiety. Lack of awareness of 'talking' therapies and poor family support were potential barriers to participant engagement. The evaluation of the research process highlighted that culturally appropriate consent procedures facilitated recruitment of participants, while incentivisation and family involvement facilitated sustained engagement and retention. Lack of women's empowerment and mental health stigma were potential barriers to implementation of the programme. CONCLUSION: We conclude that non-specialists can feasibly deliver an evidence-based intervention integrated into routine antenatal care in a tertiary hospital. Non-specialist providers are likely to be more cost effective and less stigmatising. Inclusion of family is key for participant recruitment, retention and engagement with the intervention. TRIAL REGISTRATION NUMBER: NCT03880032.
