0317 A single-arm proof-of-concept clinical trial of a mindfulness-based intervention for prenatal insomnia

Abstract

Abstract Introduction Cognitive behavioral therapy for insomnia (CBTI) improves sleep in pregnancy, but its therapeutic benefits may be diminished in pregnancy due to undertreatment of cognitive arousal (i.e., heightened cognitive activity, especially at night). Growing evidence indicates that mindfulness-based interventions produce large reductions in cognitive arousal, which may enhance insomnia therapy outcomes. The present study was a proof-of-concept, single-arm trial of Perinatal Understanding of Mindful Awareness for Sleep (PUMAS), which places behavioral sleep strategies within a mindfulness intervention framework and tailors sleep and mindfulness components to pregnancy. We evaluated patient engagement, treatment outcomes, and patient feedback from 12 pregnant women with insomnia who received PUMAS treatment. Methods Twelve pregnant women with DSM-5 insomnia disorder were treated with six weekly telemedicine sessions of PUMAS. Patient engagement was operationalized as session attendance. Treatment outcomes were assessed before and after PUMAS, which included the insomnia severity index (ISI), Edinburgh postnatal depression scale (EPDS), pre-sleep arousal scale’s cognitive factor (PSASC), and Glasgow sleep effort scale (GSES). Patients completed the Consumer’s report treatment satisfaction scale and provided treatment feedback. Results Eleven of 12 patients completed all six sessions (91.7%). Intent-to-treat analyses revealed very large reductions in ISI (ISI: 14.50±2.50 to 3.67±3.11; p<.001, Cohen’s dz=3.05), resulting in an 83.3% insomnia remission rate (n=10/12). Among the five patients with comorbid depression (EPDS≥10), PUMAS produced large antidepressant effects (EPDS: 14.00±3.32 to 5.00±2.55; p=.004, Cohen’s dz=2.76), and all five patients remitted from depression at posttreatment. PUMAS yielded very large reductions in cognitive arousal (PSASC: 20.75±4.58 to 12.50±4.23, p<.001, Cohen’s dz=2.08) and sleep effort (GSES: 5.92±2.64 to 2.08±1.62; p<.001, Cohen’s dz=2.06). Patients reported the highest 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%). Patients identified sleep restriction and meditations as the most helpful PUMAS components. Conclusion Pregnant women with DSM-5 insomnia disorder are engaged in PUMAS, which produced large reductions in insomnia, depression, cognitive arousal, and sleep effort. Patients reported high satisfaction across several domains of functioning. This trial supports testing PUMAS in a randomized controlled trial. Support (if any)