An interventional study of Cognitive Behavioral Therapy for Insomnia (CBTI) and Perinatal-enhanced Behavioral Therapy for Insomnia in Insomnia, sponsored by Henry Ford Health System. Completed at 1 site in United States. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2024-01-19.
Sponsored by Henry Ford Health System · Not applicable, Interventional, and Treatment
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.
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.
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Exclusion Criteria:
Telemedicine Cognitive Behavioral Therapy for Insomnia (CBTI)
Behavioral: Cognitive Behavioral Therapy for Insomnia (CBTI)
Telemedicine Mindfulness Based Therapy for Insomnia (MBTI)
Behavioral: Perinatal-enhanced Behavioral Therapy for Insomnia
Minimal intervention control
Behavioral: Attention Control
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.
Effectiveness of mindfulness based therapy for insomnia for changes in insomnia symptoms - Insomnia Severity Index (ISI)
The Insomnia Severity Index (ISI) is a commonly used self-report measure of insomnia symptoms that has been validated for use in community samples and clinical trials. The ISI scores range from 0-28, with a higher score indicating a greater severity of insomnia. ISI scores \< 8 after treatment indicate remission.
Time frame: Will be assessed pretreatment, immediately posttreatment, and monthly across the 1st postnatal year
Effectiveness of mindfulness based therapy for insomnia for changes in depression symptoms- Edinburgh Postnatal Depression Scale (EPDS)
The Edinburgh Postnatal Depression (EPDS) is the most widely used depression measure in both pregnant and postnatal women. It is validated for use in community samples and clinical trials. The EPDS scores range from 0-30, with a higher score indicating a greater severity of depression.
Time frame: Will be assessed pretreatment, immediately posttreatment, and monthly across the 1st postnatal year
Effectiveness of mindfulness based therapy for insomnia for changes in cognitive arousal - Presleep Arousal Scale-Cognitive Factor
The Presleep Arousal Scale- Cognitive Factor is a commonly used self-report measure of nocturnal cognitive arousal that has been validated for use in community samples and clinical trials. The scores range from 8-40, with a higher score indicating a greater severity of nocturnal cognitive arousal.
Time frame: Will be assessed pretreatment, immediately posttreatment, and monthly across the 1st postnatal year
Plan to share: Undecided
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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Sleep Initiation and Maintenance Disorders→
Henry Ford Health System