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)
Amy Louise Finlay‐jones, Jacqueline Ann Davis, Amanda O'Donovan, Keerthi Kottampally, Rebecca Anne Ashley, Desiree Silva, Jeneva Lee Ohan, Susan L. Prescott, Jenny Downs
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial protocol (pilot feasibility study) Longitudinal Qualitative |
|---|---|
| Sample size | 75 |
| Population | Pregnant women from 18 weeks of gestational age participating in the ORIGINS longitudinal birth cohort study |
| Duration | 8 weeks |
| Topics | Meditation |
| Key findings | The protocol aims to determine whether a full-scale randomized trial comparing web-based mindfulness, loving-kindness/compassion, and progressive muscle relaxation is feasible for pregnant women. It will assess recruitment and retention, engagement and adherence, weekly well-being, and qualitative post-program experiences. Feasibility will be judged using ADePT criteria; no outcome results are reported. |
Abstract
Background: Promoting psychological well-being and preventing distress among pregnant women is an important public health goal. In addition to adversely impacting the mother’s health and well-being, 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 on the web. This project aims to pilot a three-arm randomized controlled trial (RCT) to determine the feasibility of a full-scale RCT comparing 2 web-based interventions (mindfulness vs loving-kindness and compassion) with a web-based active control condition (progressive muscle relaxation).
Objective: The primary objective of this study is to assess the feasibility of an RCT protocol comparing the 3 conditions delivered on the web as a series of instructional materials and brief daily practices over a course of 8 weeks. The second objective is to explore the experiences of women in the different intervention conditions. The third objective is to estimate SD 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 of 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 3 intervention conditions by measuring weekly changes in their well-being and engagement with the program and by conducting a qualitative analysis of postprogram interviews.
Results: This project was funded in September 2019 and received ethics approval on July 8, 2020. Enrollment to the study will commence in September 2020. Feasibility of a full-scale RCT will be assessed using ADePT (a process for decision making after pilot and feasibility trials) criteria.
Conclusions: If the study is shown to be feasible, results will be used to inform future full-scale RCTs. Evidence for flexible, scalable, and low-cost interventions could inform population health strategies to promote well-being and reduce psychological distress among pregnant women. CLINICALTRIAL: Australian New Zealand Clinical Trials Registry Number 12620000672954p; http://anzctr.org.au/ACTRN12620000672954p.aspx INTERNATIONAL REGISTERED REPORT: PRR1-10.2196/19803
Comparable studies
Other randomized controlled trials on meditation, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Alterations in Brain and Immune Function Produced by Mindfulness Meditation Healthy employees in a work environment | 2003 | Randomized controlled trial | n = 41 |
| Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients | 2000 | Randomized controlled trial | n = 145 |
| Open hearts build lives: Positive emotions, induced through loving-kindness meditation, build consequential personal resources. Working adults | 2008 | Randomized controlled trial | n = 139 |
| Short-term meditation training improves attention and self-regulation Undergraduate Chinese students | 2007 | Randomized controlled trial | n = 40 |
| Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients | 2004 | Randomized controlled trial | n = 73 |
Citations in the library
Cites 14
- The benefits of being present: Mindfulness and its role in psychological well-being. Journal of Personality and Social Psychology 2003
- Loving-kindness and compassion meditation: potential for psychological interventions. Clinical Psychology Review July 26, 2011
- Mindfulness training increases momentary positive emotions and reward experience in adults vulnerable to depression: A randomized controlled trial. Journal of Consulting and Clinical Psychology July 18, 2011
- Prospects for a clinical science of mindfulness-based intervention. American Psychologist October 1, 2015
- The effect of loving-kindness meditation on positive emotions: a meta-analytic review Frontiers in Psychology November 3, 2015
and 9 more in the library