Military Suicide Research Consortium | NCT01502319

Studies
Military Suicide Research Consortium

NCT01502319

Sponsor

VA Eastern Colorado Health Care System

Status

Completed

Last Update Posted

Oct 20, 2017Actual

Enrollment

5,400Actual

Phase

Not provided

Conditions

Suicidal and Self-injurious Behaviour

Interventions

Cognitive therapy

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

Status Module

Record Verification Date

Oct 2017

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

Sep 2010Actual

Primary Completion Date

Sep 2017Actual

Completion Date

Sep 2017Actual

First Submitted Date

Dec 9, 2011

First Submission Date that Met QC Criteria

Dec 29, 2011

First Posted Date

Dec 30, 2011Estimated

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

Oct 18, 2017

Last Update Posted Date

Oct 20, 2017Actual

Name	Class
United States Department of Defense	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

The Consortium's overall mission can be summarized as follows; each function is developed with the goal of clear military relevance:

Produce new scientific knowledge about suicidal behavior in the military that improves mental health outcomes for the investigators men and women in uniform.
Use high quality research methods and analyses to address problems in policy and practice that have a direct impact on suicide-related and other mental health outcomes for military personnel.
Disseminate Consortium knowledge, information, and findings through a variety of methods appropriate for decision makers, practitioners, and others who are accountable for ensuring the mental health of military personnel. This includes the rapid response function so that queries from decision makers and others to the Consortium are answered with speed and efficiency. Technical assistance and support for decision makers and others is an integral aspect of this Consortium function. This aspect of the Consortium will warehouse knowledge about suicidal behavior in general (e.g., from civilian and international sources as well as from military sources), so that military issues can be informed in a comprehensive manner.
Train future leaders in military suicide research through experience within a multi-disciplinary setting for Ph.D. students and postdoctoral scholars interested in research questions on military suicide of both a basic and applied nature.

Detailed Description

This is a research consortium responsible for the conduct of a wide range of studies, including clinical trials. All clinical trials funded through the consortium will be registered separately.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,400Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
All subjects		Group/Cohort label is not applicable to this umbrella protocol. The Consortium funds specific research teams who will determine the number of group(s)/cohort(s) relevant to their study.	Behavioral: Cognitive therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cognitive therapy	Behavioral	Interventional studies conducted by the consortium focus on a range of cognitive and cognitive-behavioral techniques including cognitive therapy.	All subjects

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Suicide	Specific outcomes related to suicide will vary as a function of the individual studies conducted within the consortium	varies by study

Secondary Outcomes

Measure	Description	Time Frame
Suicide	Secondary outcomes related to suicide will vary as a function of the individual studies conducted within the consortium.	varies by study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

MSRC studies are inclusive of all individuals who are eligible as defined by each study's protocol regardless of age, gender, race or ethnicity, socioeconomic status, sexual orientation, and any other demographic characteristics. Measures and treatments are translated and culturally adapted to the extent possible.

Exclusion Criteria:

Specific to each investigator's protocol.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Given the age range of active duty military, reservists, and veterans, it is expected that funded Study Principal Investigators will enroll subjects that are young adults (18 to 21 years) to Senior Citizens (over 65 years).

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter M Gutierrez, PhD	VA Eastern Colorado Health Care System	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Denver VA Medical Center		Denver	Colorado	80220	United States

References Module

Citations

Not provided

Label	URL
Consortium website, click here for more information	View source
Principal investigator organization website, click here for more information	View source

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior

ID	Term
D001521	Behavior Therapy
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities