Comparing Web-Based Mindfulness With Loving-Kindness and Compassion Training for Promoting Well-Being in Pregnancy: Protocol for a Three-Arm Pilot Randomized Controlled Trial (Preprint)

Abstract

BACKGROUND Promoting psychological wellbeing and preventing distress among pregnant women is an important public health goal. In addition to adversely impacting the mother’s health and wellbeing, psychological distress in pregnancy increases the risk of poor pregnancy outcomes, compromises infant socioemotional development and bonding, and heightens maternal and child vulnerability in the postpartum period. Mindfulness and compassion-based interventions show potential for prevention and early intervention for perinatal distress. As there is an established need for accessible, scalable, flexible, and low-cost interventions, there is increased interest in the delivery of these programs online. This project aims to pilot a three-arm randomized controlled trial (RCT) to determine the feasibility of a full-scale RCT comparing two online interventions (mindfulness versus loving-kindness/compassion) with an online active control condition (progressive muscle relaxation). OBJECTIVE The primary objective is to assess the feasibility of an RCT protocol comparing the three conditions delivered online as a series of instructional material and brief daily practices, over a course of eight weeks. The second objective is to explore the experiences of women in the different intervention conditions. The third objective is to estimate standard deviation values for the outcome measures, to inform the design of an adequately powered trial to determine the comparative efficacy of the different conditions. METHODS Pregnant women (n = 75) participating in a longitudinal birth cohort study (The ORIGINS Project) will be recruited to this study from 18 weeks gestational age. We will assess the acceptability and feasibility of recruitment and retention strategies, and the participants’ engagement and adherence to the interventions. We will also assess the experiences of women in each of the three intervention conditions by measuring weekly changes in their wellbeing and engagement with the program, as well as conducting qualitative analysis of post-program interviews. RESULTS Enrollment to the study will commence in May 2020. Feasibility for a full-scale RCT will be assessed using A Process for Decision-making after Pilot and feasibility trials (ADEPT) criteria. CONCLUSIONS If the study is shown to be feasible, results will be used to inform a future full RCT. Evidence for flexible, scalable, and low-cost interventions could inform population health strategies to promote wellbeing and reduce psychological distress among pregnant women. CLINICALTRIAL ANZCTR registration pending (Request 379262).