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Treatment for Insomnia During Pregnancy

Not Applicable
Completed
Conditions
Sleep Initiation and Maintenance Disorders
Interventions
Behavioral: Cognitive Behavioral Therapy for Insomnia
Behavioral: 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
GroupInterventionDescription
CBTICognitive Behavioral Therapy for InsomniaCognitive Behavioral Therapy for Insomnia
ABTIArousal Based Therapy for InsomniaArousal Based Therapy for Insomnia
Primary Outcome Measures
NameTimeMethod
Rate of insomnia remissionBaseline to 30 weeks postpartum
Secondary Outcome Measures
NameTimeMethod
Insomnia severityBaseline to 30 weeks postpartum
Depression severityBaseline to 30 weeks postpartum
Sleep CharacteristicsBaseline 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

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