Happy Mother, Healthy Baby (HMHB) is a phase three, two-arm, single-blind, individual randomised clinical trial conducted in the outpatient department of Holy Family Hospital (HFH), a large public tertiary care facility affiliated with Rawalpindi Medical University (RMU).
HMHB is a psychosocial intervention based on CBT for expectant women experiencing anxiety during early pregnancy to mid pregnancy. It draws on the core principles and strategies of the Thinking Healthy Program, an evidence-based psychosocial intervention for mothers experiencing perinatal depression, including psychoeducation, empathetic listening, thought challenging, behaviour activation, family involvement and problem management.35 36 (link) Our formative qualitative research immediately prior to the trial indicated the following risk factors for anxiety: adverse life events, interpersonal problems, lack of support, financial problems, lack of appropriate healthcare, gender preference, pregnancy complications and fear of labour (see Atif et al37 (link) for details). These risk factors are consistent with evidence from other studies conducted in Pakistan.9 38–40 (link)
The intervention is tailored to address risk factors specific to anxiety during pregnancy that were identified in our formative research. It additionally incorporates stress management skills such as breathing exercises. Culturally relevant customised illustrations are used for guided discovery, behaviour activation, stress management and conveying key health messages. The intervention is a series of 5-weekly one-on-one sessions in early to mid pregnancy complemented by take-home exercises
Women randomised to the control group will receive enhanced usual care (EUC). WHO recommends eight prenatal visits for positive pregnancy experience,41 which is the target number of visits for study participants in the EUC control group (depending on their gestational week at enrolment). These visits will involve evaluating health status, discussing any concerns and performing routine examinations consistent with the stage of pregnancy (