Treatment for Insomnia During Pregnancy

Not Applicable

Completed

• Conditions: Sleep Initiation and Maintenance Disorders

• 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

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-30
• Study First Submitted QC: 2013-04-30
• Study First Posted: 2013-05-03
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-19
• Last Update Posted: 2018-07-23

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.

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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