Treatment for Insomnia During Pregnancy
Not Applicable
Completed
- Conditions
- Sleep Initiation and Maintenance Disorders
- Interventions
- Behavioral: Cognitive Behavioral Therapy for InsomniaBehavioral: Arousal Based Therapy for Insomnia
- Registration Number
- NCT01846585
- Lead Sponsor
- Stanford University
- Brief Summary
The aim of the study is to improve sleep during pregnancy and the postpartum period in women who are experiencing insomnia, using a brief non-pharmacological treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 194
Inclusion Criteria
- Meets Diagnostic and Statistical Manual (IV-TR edition) criteria for insomnia (duration criterion - 1 month)
- Pregnant with gestational age between 18-32 weeks.
- Adequately fluent in English or Spanish.
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Exclusion Criteria
- Some co-morbid sleep disorders (e.g., moderate to severe obstructive sleep apnea)
- Co-morbid psychiatric disorder
- Use of medications, herbs or other drugs with known effects on sleep
- Unstable medical conditions
- Currently engaged in psychotherapy or other treatments for insomnia
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CBTI Cognitive Behavioral Therapy for Insomnia Cognitive Behavioral Therapy for Insomnia ABTI Arousal Based Therapy for Insomnia Arousal Based Therapy for Insomnia
- Primary Outcome Measures
Name Time Method Rate of insomnia remission Baseline to 30 weeks postpartum
- Secondary Outcome Measures
Name Time Method Insomnia severity Baseline to 30 weeks postpartum Depression severity Baseline to 30 weeks postpartum Sleep Characteristics Baseline to 30 weeks postpartum Self-report measures characterizing sleep onset latency (time to fall asleep), wake after sleep onset, sleep duration.
Trial Locations
- Locations (1)
Stanford University
🇺🇸Palo Alto, California, United States