Treatment for Insomnia During Pregnancy
Primary Purpose
Sleep Initiation and Maintenance Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Arousal Based Therapy for Insomnia
Cognitive Behavioral Therapy for Insomnia
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Initiation and Maintenance Disorders
Eligibility 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
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
ABTI
CBTI
Arm Description
Arousal Based Therapy for Insomnia
Cognitive Behavioral Therapy for Insomnia
Outcomes
Primary Outcome Measures
Rate of insomnia remission
Secondary Outcome Measures
Insomnia severity
Depression severity
Sleep Characteristics
Self-report measures characterizing sleep onset latency (time to fall asleep), wake after sleep onset, sleep duration.
Full Information
NCT ID
NCT01846585
First Posted
April 30, 2013
Last Updated
July 19, 2018
Sponsor
Stanford University
Collaborators
National Institute of Nursing Research (NINR)
1. Study Identification
Unique Protocol Identification Number
NCT01846585
Brief Title
Treatment for Insomnia During Pregnancy
Official Title
The Effectiveness of Non-Pharmacological Treatment for Insomnia During Pregnancy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Institute of Nursing Research (NINR)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Initiation and Maintenance Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
194 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ABTI
Arm Type
Other
Arm Description
Arousal Based Therapy for Insomnia
Arm Title
CBTI
Arm Type
Other
Arm Description
Cognitive Behavioral Therapy for Insomnia
Intervention Type
Behavioral
Intervention Name(s)
Arousal Based Therapy for Insomnia
Intervention Description
Intervention includes education about sleep and a desensitization technique to reduce sleep interfering arousal
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for Insomnia
Intervention Description
Intervention includes education about sleep and behavioral and cognitive strategies to improve sleep
Primary Outcome Measure Information:
Title
Rate of insomnia remission
Time Frame
Baseline to 30 weeks postpartum
Secondary Outcome Measure Information:
Title
Insomnia severity
Time Frame
Baseline to 30 weeks postpartum
Title
Depression severity
Time Frame
Baseline to 30 weeks postpartum
Title
Sleep Characteristics
Description
Self-report measures characterizing sleep onset latency (time to fall asleep), wake after sleep onset, sleep duration.
Time Frame
Baseline to 30 weeks postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Manber, Ph.D.
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31734620
Citation
King LS, Rangel E, Simpson N, Tikotzky L, Manber R. Mothers' postpartum sleep disturbance is associated with the ability to sustain sensitivity toward infants. Sleep Med. 2020 Jan;65:74-83. doi: 10.1016/j.sleep.2019.07.017. Epub 2019 Jul 27.
Results Reference
derived
PubMed Identifier
30969203
Citation
Manber R, Bei B, Simpson N, Asarnow L, Rangel E, Sit A, Lyell D. Cognitive Behavioral Therapy for Prenatal Insomnia: A Randomized Controlled Trial. Obstet Gynecol. 2019 May;133(5):911-919. doi: 10.1097/AOG.0000000000003216.
Results Reference
derived
Learn more about this trial
Treatment for Insomnia During Pregnancy
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