0371 Acute effects of cannabinoids in insomnia disorder: a randomised, placebo-controlled trial using high-density EEG

Abstract

group allocation. They were told to practice ZTEx or follow sleep hygiene instructions for 24 weeks. The primary outcome measure was the Insomnia Severity Index (ISI) at weeks 8, 16, and 24. The secondary outcomes included sleep parameters by subjective sleep diaries and objective actigraphy; objective physical activity levels assessed by waist-worn accelerome-ters; and anxiety, depression, and fatigue levels evaluated by questionnaires. Results: Compared with the SHE group, a significantly greater reduction of ISI was observed in the ZTEx group at week 24 (d = 0.60, P = 0.005). No significant between-group difference was observed in sleep parameters measured by sleep diary or actigraph at all study visits, except that sleep-diary-derived wake time after sleep onset was significantly lower in the ZTEx group at week 8 (d = 0.24, P = 0.035). The ZTEx group showed a significant improvement in the Multidimensional Fatigue Inventory (MFI) reduced-activity subscore (d = 0.27, P = 0.036) and reduced-motivation subscore (d = 0.33, P = 0.013) at week 8, but also a higher MFI physical fatigue (d =-0.58, P = 0.008). Abstract citation ID: zsad077.0370 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 prena-tal 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 mind-fulness 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 cog-nitive arousal). Treatment outcomes were analyzed via general