Skip to main content
OpenTrials
Completed

NCT Number: NCT01846585

Treatment for Insomnia During Pregnancy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sleep Initiation and Maintenance Disorders Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Palo Alto, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arousal Based Therapy for Insomnia

Behavioral

Intervention includes education about sleep and a desensitization technique to reduce sleep interfering arousal

Cognitive Behavioral Therapy for Insomnia

Behavioral

Intervention includes education about sleep and behavioral and cognitive strategies to improve sleep

Primary outcomes

  1. Rate of insomnia remission

    Time frame: Baseline to 30 weeks postpartum

Secondary outcomes

  1. Insomnia severity

    Time frame: Baseline to 30 weeks postpartum

  2. Depression severity

    Time frame: Baseline to 30 weeks postpartum

  3. Sleep Characteristics

    Time frame: Baseline to 30 weeks postpartum

    Self-report measures characterizing sleep onset latency (time to fall asleep), wake after sleep onset, sleep duration.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

The Effectiveness of Non-Pharmacological Treatment for Insomnia During Pregnancy

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
May 3, 2013
Registry last updated
Jul 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.