Treatment for Insomnia During Pregnancy

This study is currently recruiting participants.
Verified July 2013 by Stanford University
Sponsor:
Collaborators:
University of San Diego
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01846585
First received: April 30, 2013
Last updated: July 16, 2013
Last verified: July 2013
  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
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.


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 Behavioral: Arousal Based 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
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         
University of San Diego Not yet recruiting
San Diego, California, United States, 92110
Contact: Joanna Beer, M.A.    858-966-7703 ext 7230    jbeer@casrc.org   
Principal Investigator: Cynthia Connelly, Ph.D.         
Sponsors and Collaborators
Stanford University
University of San Diego
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: July 16, 2013
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 April 15, 2014