We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment for Insomnia During Pregnancy

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01846585
First Posted: May 3, 2013
Last Update Posted: April 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Rachel Manber, Stanford University
April 30, 2013
May 3, 2013
April 17, 2017
April 2013
March 2018   (Final data collection date for primary outcome measure)
Rate of insomnia remission [ Time Frame: Baseline to 30 weeks postpartum ]
Same as current
Complete list of historical versions of study NCT01846585 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Treatment for Insomnia During Pregnancy
The Effectiveness of Non-Pharmacological 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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Sleep Initiation and Maintenance Disorders
  • Behavioral: Arousal Based Therapy for Insomnia
    Intervention includes education about sleep and a desensitization technique to reduce sleep interfering arousal
  • Behavioral: Cognitive Behavioral Therapy for Insomnia
    Intervention includes education about sleep and behavioral and cognitive strategies to improve sleep
  • ABTI
    Arousal Based Therapy for Insomnia
    Intervention: Behavioral: Arousal Based Therapy for Insomnia
  • CBTI
    Cognitive Behavioral Therapy for Insomnia
    Intervention: Behavioral: Cognitive Behavioral Therapy for Insomnia
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
184
March 2019
March 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01846585
23501
R01NR013662-01 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Rachel Manber, Stanford University
Stanford University
National Institute of Nursing Research (NINR)
Principal Investigator: Rachel Manber, Ph.D. Stanford University
Stanford University
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP