NCT01958541

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 9, 2013

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

April 26, 2018

Status Verified

April 1, 2018

Enrollment Period

4.5 years

First QC Date

October 7, 2013

Last Update Submit

April 25, 2018

Conditions

InsomniaDepressionSuicidal Ideation

Keywords

SleepInsomniaSuicidal SymptomsSuicidal IdeationMilitary VeteranService MemberDepression

Outcome Measures

Primary Outcomes (1)

  • Suicidal Ideation

    Change from Baseline in Suicidal Ideation at 7 weeks

Secondary Outcomes (1)

  • Insomnia Symptoms

    Change from Baseline in Insomnia Symptoms at 7 weeks

Study Arms (2)

Behavioral Intervention I

EXPERIMENTAL

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

Behavioral: Sleep Intervention I

Behavioral Intervention II

ACTIVE COMPARATOR

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

Behavioral: Sleep Intervention II

Interventions

Sleep Intervention IBEHAVIORAL

Insomnia-focused behavioral treatment (4 sessions).

Behavioral Intervention I
Sleep Intervention IIBEHAVIORAL

Insomnia-focused behavioral treatment (4 sessions).

Behavioral Intervention II

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* Age 18 or older * Veteran * Insomnia Symptoms * Depression

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

VA Palo Alto Healthcare System

Palo Alto, California, 94304, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersDepressionSuicidal Ideation

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersBehavioral SymptomsBehaviorSuicideSelf-Injurious Behavior

Study Officials

  • Rebecca A Bernert, Ph.D.

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 7, 2013

First Posted

October 9, 2013

Study Start

March 1, 2013

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

April 26, 2018

Record last verified: 2018-04

Locations

US(2)