Perinatal Understanding of Mindful Awareness for Sleep (PUMAS): A single-arm proof-of-concept clinical trial of a mindfulness-based intervention for DSM-5 insomnia disorder during pregnancy.
David A Kalmbach, Philip Cheng, Anthony N Reffi, Jason C Ong, Leslie M Swanson, David M. Fresco, Olivia Walch, Grace M Seymour, Cynthia Fellman-Couture, Alec D Bayoneto, Thomas Roth, Christopher L Drake
Sleep Medicine August 1, 2023 DOI: 10.1016/j.sleep.2023.05.026 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Single-arm trial Peer reviewed |
|---|---|
| Sample size | 12 |
| Population | Pregnant women with DSM-5 insomnia disorder |
| Intervention | Perinatal Understanding of Mindful Awareness for Sleep (PUMAS) |
| Duration | Six sessions |
| Topics | Depression Meditation |
| Keywords | Cognitive arousal Pumas Pregnancy Rumination Worry |
| Citations | 15 |
| Registration | NCT04443959 |
| Key findings | PUMAS produced large acute reductions in insomnia, depression, and cognitive arousal in pregnant women with insomnia, with 83.3% achieving insomnia remission and all five baseline depressed patients remitting from depression. |
Abstract
Cognitive-behavioral therapy is effective for prenatal insomnia, but unresolved cognitive arousal limits patient outcomes. Therapies aimed at reducing cognitive arousal may benefit pregnant women with insomnia. This proof-of-concept trial evaluated Perinatal Understanding of Mindful Awareness for Sleep (PUMAS, which combines mindfulness with behavioral sleep strategies) on insomnia, depression, and cognitive arousal. A single-arm trial of 12 pregnant women with DSM-5 insomnia disorder (n = 5/12 with comorbid depression) who received six sessions of PUMAS delivered individually via telemedicine. Pretreatment and posttreatment outcomes included the insomnia severity index (ISI), Edinburgh postnatal depression scale (EPDS), pre-sleep arousal scale's cognitive factor (PSASC; nocturnal cognitive arousal), perinatal-focused rumination (appended to PSASC), and Glasgow sleep effort scale. Eleven of 12 patients completed all sessions. Intent-to-treat analyses revealed a 10.83-point reduction in ISI (Cohen's dz = 3.05), resulting in 83.3% insomnia remission. PUMAS produced large reductions in EPDS (Cohen's dz = 2.76 in depressed group), resulting in all five baseline depressed patients remitting from depression. PUMAS produced large reductions in nocturnal cognitive arousal, perinatal-focused rumination, and sleep effort (all Cohen's dzs>2.00). Patients were highly satisfied with PUMAS and identified the telemedicine format and meditation app as positive features of its delivery. Patients rated sleep restriction and guided meditations as the most helpful treatment components. Prenatal insomnia patients were highly engaged in PUMAS, which produced large acute reductions in insomnia, depression, and cognitive arousal. These findings support the concept and feasibility of PUMAS for pregnant women with insomnia who present with or without comorbid depression. NCT04443959.
Comparable studies
Other non-randomized and open-label trials on meditation, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Mindfulness-Based Stress Reduction in Relation to Quality of Life, Mood, Symptoms of Stress, and Immune Parameters in Breast and Prostate Cancer Outpatients Early-stage breast and prostate cancer patients | 2003 | Pre-post intervention study | n = 59 |
| Exploring self‐compassion and empathy in the context of mindfulness‐based stress reduction (MBSR) Community sample | 2010 | Pre-post intervention study | |
| Mindfulness-Based Stress Reduction Lowers Psychological Distress In Medical Students Second-year medical students | 2003 | Prospective nonrandomized cohort-controlled study | n = 302 |
| Intensive meditation training, immune cell telomerase activity, and psychological mediators. Retreat participants and matched controls | 2011 | Controlled trial with wait-list control group | n = 60 |
| The Effectiveness of Mindfulness Training for Children with ADHD and Mindful Parenting for their Parents Children aged 8-12 with ADHD and their parents | 2011 | Within-group waitlist controlled trial | n = 22 |
Citations in the library
Cited by 5
- Reducing cognitive arousal and sleep effort alleviates insomnia and depression in pregnant women with DSM-5 insomnia disorder treated with a mindfulness sleep program. SLEEP Advances 2023
- Preliminary evidence of psychological improvements and increased maternal-fetal attachment associated with a mindfulness sleep programme: secondary analysis of uncontrolled data in 11 pregnant women with insomnia disorder. Journal of Sleep Research February 1, 2024
- Efficacy of Mindfulness Meditation on Patients With Stroke With Concurrent Coronary Heart Disease: A Randomised Controlled Trial. Clinical Psychology & Psychotherapy 2024
- The Impact of Mindfulness Programmes on Anxiety, Depression and Stress During Pregnancy: A Systematic Review and Meta-Analysis. Healthcare June 9, 2025
- Treating insomnia during pregnancy improves bedtime procrastination, rumination, anxiety, and positive affect: a randomized controlled trial of cognitive-behavioral and mindfulness-based therapies for prenatal insomnia. SLEEP Advances 2026
Cites 10
- A Randomized Controlled Trial of Mindfulness Meditation for Chronic Insomnia Sleep August 29, 2014
- Group, One-on-One, or Internet? Preferences for Mindfulness Meditation Delivery Format and their Predictors Open Medicine Journal November 28, 2014
- The mindful moms training: development of a mindfulness-based intervention to reduce stress and overeating during pregnancy BMC Pregnancy and Childbirth June 1, 2018
- Mindfulness and nocturnal rumination are independently associated with symptoms of insomnia and depression during pregnancy. Sleep Health March 4, 2020
- Mindfulness-based cognitive therapy for psychological distress in pregnancy: study protocol for a randomized controlled trial. Trials October 13, 2016
and 5 more in the library