A Brief Behavioral Sleep Intervention for Depression Amon... | NCT01958541

Studies
A Brief Behavioral Sleep Intervention for Depression Among Military Veterans

NCT01958541

Sponsor

Stanford University

Status

Completed

Last Update Posted

Apr 26, 2018Actual

Enrollment

77Actual

Phase

Not Applicable

Conditions

Insomnia
Depression
Suicidal Ideation

Interventions

Sleep Intervention I
Sleep Intervention II

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
W81XWH-10-2-0178	Other Grant/Funding Number	Department of Defense

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Sep 2017Actual

Completion Date

Sep 2017Actual

First Submitted Date

Oct 7, 2013

First Submission Date that Met QC Criteria

Oct 7, 2013

First Posted Date

Oct 9, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2018

Last Update Posted Date

Apr 26, 2018Actual

Name	Class
VA Palo Alto Health Care System	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

77Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Sleep Intervention I	Behavioral	Insomnia-focused behavioral treatment (4 sessions).	Behavioral Intervention I

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Suicidal Ideation		Change from Baseline in Suicidal Ideation at 7 weeks

Secondary Outcomes

Measure	Description	Time Frame
Insomnia Symptoms		Change from Baseline in Insomnia Symptoms at 7 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Age 18 or older
Veteran
Insomnia Symptoms
Depression

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rebecca A Bernert, Ph.D.	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
VA Palo Alto Healthcare System		Palo Alto	California	94304	United States
Stanford University

Condition Browse Module

MeSH Terms

ID	Term
D007319	Sleep Initiation and Maintenance Disorders
D003863	Depression
D059020	Suicidal Ideation

Ancestor Terms

ID	Term
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided