0370 A three-arm randomized controlled trial examining mindfulness-based and cognitive-behavioral therapies 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). A recent proof-of-concept, single-arm trial suggested that combining behavioral sleep strategies with mindfulness components produced large reductions in prenatal insomnia, depression, and cognitive arousal. The present study was a randomized controlled trial evaluating the effectiveness of this mindfulness-based intervention and CBTI relative to a control condition. Methods Sixty-four pregnant women with clinically significant insomnia symptoms were randomized to a mindfulness-based intervention, CBTI, or control. The mindfulness intervention was Perinatal Understanding of Mindful Awareness for Sleep (PUMAS), which places behavioral sleep strategies within a mindfulness framework and tailors all components to pregnancy. PUMAS and CBTI were delivered via six telemedicine sessions, whereas control patients electronically received six weekly information sheets on perinatal sleep health. Treatment outcomes were assessed before and after treatment, which included the insomnia severity index (ISI), Edinburgh postnatal depression scale (EPDS), and pre-sleep arousal scale’s cognitive factor (PSASC; nocturnal cognitive arousal). Treatment outcomes were analyzed via general linear models, and the PRODCLIN method tested mediation models in evaluation of treatment mechanisms. Results Intent-to-treat analyses revealed significant ISI reductions in the PUMAS (-11.05±3.84) and CBTI (-11.20±6.87) conditions relative to control (-4.27±1.96). Insomnia remission rates were highest among PUMAS patients (81.8%), whereas 65.0% of CBTI patients and 13.6% of controls remitted. PUMAS significantly alleviated depression relative to control (EPDS: -3.77±3.88 vs -0.59±2.84, p=.017), whereas CBTI did not differ from either group (EPDS: -2.55±4.25, p-values ≥ .271). Similarly, PUMAS alleviated cognitive arousal relative to control (PSASC: -8.82±4.99 vs -3.45±4.53, p=.009), whereas CBTI did not differ from either group (PSASC: -7.30±7.49, p-values ≥ .104). Mediation analyses estimated that reductions in cognitive arousal mediated 26.6% and 40.6% of PUMAS effects on insomnia and depression. Conclusion PUMAS alleviated insomnia, depression, and cognitive arousal relative to control. Reducing cognitive arousal was a significant treatment mechanism by which PUMAS alleviated insomnia and depression. By comparison, CBTI significantly alleviated insomnia relative to control, but yielded no significant effects on depression or cognitive arousal. Support (if any)