Evaluation of ProVetus/Sponsorship Initiative

NCT02627612 | Completed

• 1 other identifier: 14-225
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

Brief Summary

Some Veterans who recently served in the military report significant psychological problems based on their experiences in the military. Stressors that these Veterans face when they transition out of the military can acerbate these problems and negatively impact their long-term physical and psychological well-being. The investigators are conducting a randomized controlled trial to evaluate the efficacy of providing Veterans who are transitioning back into their civilian communities trained, peer mentorship (Pro Vetus) and membership in a Veteran Support Organization (VSO) Team Red, White, and Blue (TM RWB) to reduce transition stressors, maintain psychological and physical health, reduce suicides and reduce criminal incidents.

Conditions

Posttraumatic Stress Disorder; Reintegration; Social Support

Keywords

veteran; mentorship; Iraq/Afghanistan; treatment; PTSD; Suicide; Criminal Activity

Outcome Measures

Primary Outcomes (4)

• Change in baseline PCL (PTSD) scores across 3 timepoints

  Baseline, 3 months after, 10 months after, 16 months after

• Change in baseline Military to Civilian Questionnaire scores across 3 timepoints

  Baseline, 3 months after, 10 months after, 16 months after

• Change in baseline Social Support Scale scores across 3 timepoints

  Baseline, 3 months after, 10 months after, 16 months after

• Change in baseline suicidality across 2 timepoints

  Outcome measured through Mortality (Suicide) Data Center for Disease Control

  16 months after baseline and 5 years after baseline

Secondary Outcomes (7)

• Change in baseline Veteran Rand 36 scores across 3 timepoints

  Baseline, 3 months after, 10 months after, 16 months after

• Change in baseline PHQ-15 scores across 3 time points

  Baseline, 3 months after, 10 months after, 16 months after

• Change in baseline Criminal Background Record across 3 timepoints

  Baseline, 3 months after, 10 months after, 16 months after

• Change in baseline Criminal Background Self-Report across 3 timepoints

  Baseline, 3 months after, 10 months after, 16 months after

• Change in baseline AUDIT-C (Alcohol Use) scores across 3 time points

  Baseline, 3 months after, 10 months after, 16 months after

Study Arms (3)

TM RWB PLUS Pro Vetus

EXPERIMENTAL

Research participants will receive an introductory email from the research team informing them that they were randomly assigned to this group and request that they voluntarily join TM RWB and receive mentorship from their matched and assigned mentor. In addition to TM RWB membership, research participants will also receive approximately four months of mentorship from a ProVetus mentor to assist them in further transitioning within the five domains.

Behavioral: Pro Vetus; Behavioral: Team Red, White, and Blue (TM RWB)

TM RWB ONLY

ACTIVE COMPARATOR

Research participants will receive an introductory email from the research team informing them that they were randomly assigned to this arm and request that they voluntarily join TM RWB. Weekly emails will provide lists of voluntary physical/social activities available to all Chapter members. No participation is required in these activities.

Behavioral: Team Red, White, and Blue (TM RWB)

Control Group (Waitlist)

NO INTERVENTION

Research participants (recent Veterans) will be placed on a waitlist for approximately sixteen months. Based on their desires, the research participants in this group will have opportunity to belong to TM RWB plus receive approximately four months of mentorship from trained, peer-mentors (who are TM RWB volunteers).

Interventions

Pro Vetus BEHAVIORAL

Volunteer mentors (a mix of Veterans and non-Veterans) in the civilian community work with transitioning Veterans for approximately four months within five transition domains (1. Employment/Education, 2. Housing, 3. Family and Legal, 4. Social/Community/ Physical Fitness and 5. Medical Care).

TM RWB PLUS Pro Vetus

Team Red, White, and Blue (TM RWB) BEHAVIORAL

TM RWB is a 501(c)(3) non-profit, Veteran support organization found in 2010. Its mission is to enrich the lives of America's Veterans by connecting them to their community through physical and social activity. Central to TM RWB's mission is that inspiring Veterans to become physically active will create opportunities to establish authentic connections to other Veterans, active duty military, and civilians as well as improve the chances for continued successful integration. Enrollment in TM RWB takes place by simply signing up online and providing a name, email address, and zip code (teamrwb.org). TM RWB is not designed as a mental health intervention.

TM RWB ONLY; TM RWB PLUS Pro Vetus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 and over, prior military service within the last twelve years, and currently reside within the NYC area (and anticipate staying within the area for at least one year) or will move to NYC area prior to December 2016 (and anticipate staying for at least one year).

You may not qualify if:

• Previous membership within Team Red, White, and Blue.

Sponsors & Collaborators

• Teachers College, Columbia University: lead

Study Sites (1)

Teachers College, Columbia University

New York, New York, 10027, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Suicide

Interventions

RID

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Joseph Geraci, LMHC

  Teachers College, Columbia University

  PRINCIPAL INVESTIGATOR

• George Bonanno, PhD

  Teachers College, Columbia University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2015
• First Posted: December 11, 2015
• Study Start: June 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: April 27, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)