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A Brief Behavioral Sleep Intervention for Depression Among Military Veterans

Primary Purpose

Insomnia, Depression, Suicidal Ideation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleep Intervention I
Sleep Intervention II
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Sleep, Insomnia, Suicidal Symptoms, Suicidal Ideation, Military Veteran, Service Member, Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • Age 18 or older
  • Veteran
  • Insomnia Symptoms
  • Depression

Sites / Locations

  • VA Palo Alto Healthcare System
  • Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Behavioral Intervention I

Behavioral Intervention II

Arm Description

This non-medication group treatment (Sleep Intervention I) consists of four 90-minute sessions.

This non-medication group treatment (Sleep Intervention II) consists of four 90-minute sessions.

Outcomes

Primary Outcome Measures

Suicidal Ideation

Secondary Outcome Measures

Insomnia Symptoms

Full Information

First Posted
October 7, 2013
Last Updated
April 25, 2018
Sponsor
Stanford University
Collaborators
VA Palo Alto Health Care System
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1. Study Identification

Unique Protocol Identification Number
NCT01958541
Brief Title
A Brief Behavioral Sleep Intervention for Depression Among Military Veterans
Official Title
A Brief Behavioral Sleep Intervention for Depression Among Military Veterans
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
VA Palo Alto Health Care System

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study investigates the impact of brief behavioral insomnia treatment on depressive symptoms among military veterans.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Depression, Suicidal Ideation
Keywords
Sleep, Insomnia, Suicidal Symptoms, Suicidal Ideation, Military Veteran, Service Member, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavioral Intervention I
Arm Type
Experimental
Arm Description
This non-medication group treatment (Sleep Intervention I) consists of four 90-minute sessions.
Arm Title
Behavioral Intervention II
Arm Type
Active Comparator
Arm Description
This non-medication group treatment (Sleep Intervention II) consists of four 90-minute sessions.
Intervention Type
Behavioral
Intervention Name(s)
Sleep Intervention I
Intervention Description
Insomnia-focused behavioral treatment (4 sessions).
Intervention Type
Behavioral
Intervention Name(s)
Sleep Intervention II
Intervention Description
Insomnia-focused behavioral treatment (4 sessions).
Primary Outcome Measure Information:
Title
Suicidal Ideation
Time Frame
Change from Baseline in Suicidal Ideation at 7 weeks
Secondary Outcome Measure Information:
Title
Insomnia Symptoms
Time Frame
Change from Baseline in Insomnia Symptoms at 7 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Age 18 or older Veteran Insomnia Symptoms Depression
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca A Bernert, Ph.D.
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Palo Alto Healthcare System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

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A Brief Behavioral Sleep Intervention for Depression Among Military Veterans

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