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Treatment for Insomnia During Pregnancy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Rachel Manber, Stanford University
ClinicalTrials.gov Identifier:
NCT01846585
First received: April 30, 2013
Last updated: April 13, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention
Sleep Initiation and Maintenance Disorders Behavioral: Arousal Based Therapy for Insomnia Behavioral: Cognitive Behavioral Therapy for Insomnia

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effectiveness of Non-Pharmacological Treatment for Insomnia During Pregnancy

Further study details as provided by Rachel Manber, Stanford University:

Primary Outcome Measures:
  • Rate of insomnia remission [ Time Frame: Baseline to 30 weeks postpartum ]

Secondary Outcome Measures:
  • Insomnia severity [ Time Frame: Baseline to 30 weeks postpartum ]
  • Depression severity [ Time Frame: Baseline to 30 weeks postpartum ]
  • 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.


Estimated Enrollment: 184
Study Start Date: April 2013
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
ABTI
Arousal Based Therapy for Insomnia
Behavioral: Arousal Based Therapy for Insomnia
Intervention includes education about sleep and a desensitization technique to reduce sleep interfering arousal
CBTI
Cognitive Behavioral Therapy for Insomnia
Behavioral: Cognitive Behavioral Therapy for Insomnia
Intervention includes education about sleep and behavioral and cognitive strategies to improve sleep

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01846585

Locations
United States, California
Stanford University
Palo Alto, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: Rachel Manber, Ph.D. Stanford University
  More Information

Responsible Party: Rachel Manber, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT01846585     History of Changes
Other Study ID Numbers: 23501
R01NR013662-01 ( U.S. NIH Grant/Contract )
Study First Received: April 30, 2013
Last Updated: April 13, 2017

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on September 21, 2017