Telemedicine Mindfulness-based Therapy for Perinatal Insomnia: An Open-label Trial.
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      Over half of pregnant and postpartum women experience clinical insomnia. However, treatment
      options are very limited for pregnant women and moms of newborns. Sleep aids are not
      considered safe during pregnancy and may increase risks about safety for mom and baby during
      postpartum. Recent clinical trials show that behavioral and mindfulness-based treatments can
      safely improve sleep and mood during pregnancy. Yet, no published studies to date have
      combined behavioral sleep treatment with mindfulness-based stress reduction to improve sleep
      and mood at the same time in pregnant and postpartum women. This study is the first to
      combine behavioral sleep strategies with mindfulness-meditation to improve sleep and
      psychological wellbeing of expecting and new moms.

      The purpose of this research study is to examine the effectiveness of a mindfulness-based
      intervention for prenatal insomnia via telemedicine format to improve sleep and mood as well
      as reduce stress in pregnant women.
    

Detailed description: 
      The purpose of this open-label trial is to determine the efficacy of and patient engagement
      in mindfulness-based intervention for prenatal insomnia delivered via telemedicine. The
      investigators' long-term goal is to improve sleep and mood of expecting and new mothers. Over
      half of pregnant women develop insomnia, which is associated with high rates of depression
      during pregnancy and postpartum. By successfully treating insomnia during pregnancy and
      improving cognitive-emotion regulation, mental health of pregnant women and new moms may be
      greatly improved. In a prior clinical trial, Dr. Kalmbach (PI) showed that online
      cognitive-behavioral therapy for insomnia (CBTI) greatly improved sleep during pregnancy, and
      offered some protection against sleep problems after childbirth. Women in this trial were
      highly satisfied with CBTI and especially its remote delivery. However, the investigators
      identified important shortcomings of online CBTI in this population. Namely, patients
      provided feedback that reducing cognitive arousal (ie ruminative or worrisome thinking) was
      an important therapeutic target, that more mindfulness-based approaches and strategies would
      improve treatment, and that greater emphasis on maternal and infant sleep would also enhance
      the treatment experience. Thus, the investigators will conduct an open label trial to collect
      pilot data on the efficacy of a telemedicine mindfulness-based intervention for prenatal
      insomnia that has been tailored for pregnant women. Specifically, the investigators will
      conduct this open-label trial of 50 pregnant women to preliminary test the efficacy, patient
      adherence, patient engagement, and patient satisfaction with this telemedicine program.

      This open-label trial will enroll 50 pregnant women (gestational age 18-30 weeks at study
      entry) who will receive 6 sessions of 'Perinatal Understanding of Mindful Awareness for
      Sleep' (PUMAS) via telemedicine video with a therapist. Patients will complete this treatment
      during pregnancy. This program was based on Dr. Jason Ong's Mindfulness-Based Therapy for
      Insomnia, which combined CBTI and mindfulness meditation, and it has been tailored for
      perinatal women. The investigators will assess study outcomes before treatment and after
      treatment. Study outcomes will include insomnia symptoms, depressive symptoms, and cognitive
      arousal. The investigators will also assess patient engagement (number of completed sessions,
      homework adherence) and collect patient feedback (e.g., treatment satisfaction).
    

Intervention name(s): PUMAS
Intervention type(s): Behavioral
Intervention description(s): Treatment consists of 6 weekly telemedicine sessions during pregnancy.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mindfulness; Cognitive arousal; insomnia; pregnant; perinatal