- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01958541
A Brief Behavioral Sleep Intervention for Depression Among Military Veterans
April 25, 2018 updated by: Rebecca Ann Bernert, Stanford University
This study investigates the impact of brief behavioral insomnia treatment on depressive symptoms among military veterans.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
77
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Palo Alto, California, United States, 94304
- VA Palo Alto Healthcare System
-
Stanford, California, United States, 94305
- Stanford University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
- Age 18 or older
- Veteran
- Insomnia Symptoms
- Depression
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Behavioral Intervention I
This non-medication group treatment (Sleep Intervention I) consists of four 90-minute sessions.
|
Insomnia-focused behavioral treatment (4 sessions).
|
Active Comparator: Behavioral Intervention II
This non-medication group treatment (Sleep Intervention II) consists of four 90-minute sessions.
|
Insomnia-focused behavioral treatment (4 sessions).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Suicidal Ideation
Time Frame: Change from Baseline in Suicidal Ideation at 7 weeks
|
Change from Baseline in Suicidal Ideation at 7 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Insomnia Symptoms
Time Frame: Change from Baseline in Insomnia Symptoms at 7 weeks
|
Change from Baseline in Insomnia Symptoms at 7 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Rebecca A Bernert, Ph.D., Stanford University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (Actual)
September 1, 2017
Study Completion (Actual)
September 1, 2017
Study Registration Dates
First Submitted
October 7, 2013
First Submitted That Met QC Criteria
October 7, 2013
First Posted (Estimate)
October 9, 2013
Study Record Updates
Last Update Posted (Actual)
April 26, 2018
Last Update Submitted That Met QC Criteria
April 25, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22427
- W81XWH-10-2-0178 (Other Grant/Funding Number: Department of Defense)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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