Treatment for Insomnia During Pregnancy

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Stanford University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01846585
First received: April 30, 2013
Last updated: May 12, 2014
Last verified: May 2014
  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 Phase
Sleep Initiation and Maintenance Disorders
Behavioral: Arousal Based Therapy for Insomnia
Behavioral: Cognitive Behavioral Therapy for Insomnia
Phase 2
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Rate of insomnia remission [ Time Frame: Baseline to 30 weeks postpartum ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Insomnia severity [ Time Frame: Baseline to 30 weeks postpartum ] [ Designated as safety issue: No ]
  • Depression severity [ Time Frame: Baseline to 30 weeks postpartum ] [ Designated as safety issue: No ]
  • Sleep Characteristics [ Time Frame: Baseline to 30 weeks postpartum ] [ Designated as safety issue: No ]
    Self-report measures characterizing sleep onset latency (time to fall asleep), wake after sleep onset, sleep duration.


Estimated Enrollment: 186
Study Start Date: April 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arousal Based Therapy for Insomnia
Arousal Based Therapy for Insomnia
Behavioral: Arousal Based Therapy for Insomnia
Cognitive Behavioral Therapy for Insomnia
Cognitive Behavioral Therapy for Insomnia
Behavioral: Cognitive Behavioral Therapy for Insomnia

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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

Contacts
Contact: Haddas Elisha, BSc 650-723-2641 helisha@stanford.edu

Locations
United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94305
Contact: Haddas Elisha, BSc    650-723-2641    helisha@stanford.edu   
Principal Investigator: Rachel Manber, PhD         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Rachel Manber, Ph.D. Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01846585     History of Changes
Other Study ID Numbers: 23501, R01NR013662-01
Study First Received: April 30, 2013
Last Updated: May 12, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 18, 2014