PUMAS Intervention Results in Greater Insomnia Remission Rates, Reduced Depression in Prenatal Insomnia Than CBT-I

In a comparative study, findings showed that a mindfulness-based intervention—Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)—was more effective than cognitive behavioral therapy-insomnia (CBT-I) for insomnia remission in a cohort of pregnant women, and significantly outperformed control on outcomes of depression, insomnia, and cognitive arousal.

These data were presented at 2023 SLEEP Annual Meeting, June 3-7, in Indianapolis, Indiana, by senior Christopher Drake, PhD, section head, Sleep Research, Henry Ford Hospital. The intent-to-treat analysis, which comprised of 64 pregnant women, showed significant reductions in Insomnia Severity Index (ISI) in those randomly assigned to PUMAS (­–11.05 [±3.84]) and CBT-I (–11.20 [±6.87]) relative to control (–4.27 [±1.96]). Treatment outcomes were analyzed through general linear models, while the PRODCLIN method tested mediation models in evaluation of treatment mechanisms.

The mindfulness intervention, PUMAS, placed behavioral sleep strategies within a mindfulness framework and tailored all components to pregnancy. Both the PUMAS and CBT-I groups received 6 telemedicine sessions, whereas controls electronically received 6 weekly information sheets on perinatal sleep health. At the conclusion of the trial, the PUMAS group showed the highest rate of insomnia remission (81.8%), followed by CBT-I (65.0%) and controls (13.6%).

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In comparison with controls, those assigned to PUMAS showed significantly alleviated depression, as expressed by scores on Edinburgh postnatal depression scale (EPDS; –3.77 [±3.88] vs –0.59 [±2.84]; P = .017), whereas CBT-I did not differ (–2.55 [±4.25]; P = .017). Pre-sleep arousal scale’s cognitive factor (PSASC), which assessed cognitive arousal, was significantly alleviated in the PUMAS group relative to controls (–8.82 [±4.99] vs –3.45 [±4.53]; P = 009), whereas CBT-I did not differ from either group (–7.30 [±7.49]; P ≥.104). Mediation analyses estimated that reductions in cognitive arousal mediated 26.0% and 40.6% of PUMAS effects on insomnia and depression.

Drake and colleagues presented another study at SLEEP 2023, assessing a small cohort of pregnant women with insomnia who received 6 weekly telemedicine sessions of PUMAS. Eleven of the 12 patients completed all 6 sessions (91.7%). Intent-to-treat analyses revealed large reductions in ISI (14.50 [±2.50] to 3.67 [±3.11]; P <.001; Cohen’s d = 3.05), resulting in an 83.3% insomnia remission rate (n = 10). Patients reported high rates of treatment satisfaction for improvement in insomnia (100%), energy (90.9%), pregnancy stress (90.9%), mood (90.9%), and coping with stress (83.3%).

Among the 5 participants with comorbid depression (EPDS: 14.00 [±3.32] to 5.00 [±2.55] P = .004; Cohen’s d = 2.76), and all 5 participants remitted from depression at posttreatment. Additionally, PUMAS yielded large reductions in cognitive arousal (PSASC: 20.75 [±4.58] to 12.50 [±4.23]; P <.001; Cohen’s d = 2.08) and sleep effort, as demonstrated by Glasgow Sleep Effort Scale (5.92 [±2.64] to 2.08 [±1.62]; P <.001; Cohen’s d = 2.06).

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REFERENCES
1. Kalmbach D, Cheng P, Ong J, et al. A three arm randomized controlled trial examining mindfulness-based and cognitive-behavioral therapies for prenatal insomnia. Presented at: 2023 SLEEP Annual Meeting; June 3-7; Indianapolis, Indiana. Abstract 0370
2. Seymour G, Kalmbach D, Cheng P, et al. A single-arm proof-of-concept clinical trial of mindfulness-based intervention for prenatal insomnia. Presented at: 2023 SLEEP Annual Meeting; June 3-7; Indianapolis, Indiana. Abstract 0317