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Treatment for Insomnia During Pregnancy

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by Stanford University
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: November 1, 2016
Last verified: November 2016
  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

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: 184
Study Start Date: April 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (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)
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: Elizabeth Rangel, BSc 650-723-2641 erangel@stanford.edu
Contact: Michelle Reade, BSc 650 725-0947 mreade@stanford.edu

Locations
United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94305
Contact: Elizabeth Rangel, BSc    650-723-2641    erangel@stanford.edu   
Contact: Michelle Reade, BSc    650 725-0947    mreade@stanford.edu   
Principal Investigator: Rachel Manber, PhD         
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 
Study First Received: April 30, 2013
Last Updated: November 1, 2016
Health Authority: United States: Institutional Review Board

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 December 02, 2016