Improving Negative Stressful Perseverations in Insomnia to Revitalize Expectant Moms
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      The purpose of this research is to evaluate telemedicine treatments for sleep in pregnant
      women. As pregnant women are vulnerable to sleep problems, the investigators aim to explore
      whether these types of treatment will improve sleep and mood-related health risks in
      pregnancy and postpartum. The investigators will test the efficacy of cognitive behavioral
      therapy for insomnia (CBTI) and mindfulness-based therapy for insomnia (MBTI) for perinatal
      insomnia relative to sleep education and hygiene, which is a minimal intervention control.
    

Detailed description: 
      The purpose of this randomized controlled trial is to determine the efficacy of cognitive
      behavioral therapy for insomnia (CBTI) and mindfulness-based therapy for insomnia (MBTI) for
      perinatal insomnia relative to sleep education and hygiene, which is a minimal intervention
      control. The long-term goal is to maximize the effectiveness of insomnia treatment for
      perinatal women by adapting safe and efficacious treatments to meet the evolving needs of
      women through pregnancy and postpartum. 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 and postpartum women may be substantially improved. In a prior clinical trial,
      Dr. Kalmbach (PI) showed that digital CBTI (i.e., fully automated online program) improved
      sleep during pregnancy, and offered some protection against sleep problems after childbirth.
      Women in this prior trial were highly satisfied with CBTI and the ability to participate in
      treatment remotely. However, the investigators identified important shortcomings of CBTI in
      this population. Namely, standard CBTI was ineffective at reducing cognitive arousal and
      depression. Preliminary data suggest that MBTI may effectively reduce cognitive arousal in
      insomnia patients, which has immense potential to enhance sleep and mental health outcomes in
      perinatal insomnia. Thus, the investigators will conduct a randomized controlled trial to
      determine the efficacy of MBTI and CBTI for perinatal insomnia relative to a minimal
      intervention control.

      The current study is a 3-arm RCT comparing CBTI and MBTI to sleep education and hygiene
      minimal intervention control for the treatment of perinatal insomnia. 120 women with insomnia
      symptoms will be treated beginning in pregnancy and into early postpartum. CBTI and MBTI will
      address changes in sleep symptoms and challenges that emerge after childbirth. The
      investigators will collect outcome data on insomnia symptoms and related health outcomes
      (e.g., cognitive arousal, depression) after prenatal treatment and monthly across the first
      postpartum year. The investigators will determine the efficacy of the investigator's CBTI and
      MBTI protocols for perinatal insomnia relative to minimal intervention control. The
      investigators will then compare the effects of CBTI and MBTI on short- and long-term
      outcomes.
    

Intervention name(s): Cognitive Behavioral Therapy for Insomnia (CBTI); Perinatal-enhanced Behavioral Therapy for Insomnia; Attention Control
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Consists of 6 prenatal 60-min sessions and 6 monthly postnatal sessions on sleep education, sleep restriction, stimulus control, cognitive therapy, and relaxation. Treatment will be delivered via telemedicine.; Consists of 6 prenatal 60-min sessions and 6 monthly postnatal sessions on sleep education, sleep restriction, stimulus control, and metacognitive exercises. Treatment will be delivered via telemedicine.; Will include education on sleep, circadian rhythms, and good sleep hygiene in addition to self-monitoring with sleep diaries.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Insomnia; Telemedecine; pregnancy; perinatal; Cognitive Arousal; depression