Posttraumatic Stress Disorder Clinical Trial
Official title:
Evaluation of ProVetus/Sponsorship Initiative
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.
The evidence basis suggests that the pre-existing psychological states of those who enter the
military, compounded by combat exposure, may further deteriorate with the loss of leadership
and social support by leaving the structured military environment. In a perfect situation,
practitioners could simply track these "at risk" individuals throughout their military
service and then ensure that they received medical services through the Veterans Affairs
after transitioning to the civilian sector. It would appear that such an approach would help
to reduce suicide in Veterans since studies have shown that Vietnam Veterans with a
posttraumatic stress disorder (PTSD) diagnosis approximately forty years after Vietnam (i.e.,
worsening chronic or high-stable) were almost 3 times more likely to have a suicide attempt
compared to Veterans without PTSD. Additionally, the suicide rate for Veterans who actually
do seek VA healthcare services has improved in recent years (approximately 34 per 100,000 in
2008 to approximately 28 per 100,000 in 2010). This is a testament to the services that the
VA is providing Veterans who seek care.
Unfortunately, this approach has not been fully successful for two reasons. First, many of
the transitioning Veterans who need services the most will not seek these services primarily
because of the prevalent stigma against mental health services among Veterans. For example,
previous research found that only 34 percent of National Guard Veterans who screened positive
for PTSD after a deployment to Afghanistan actually sought treatment within their first year
after redeploying home and transitioning back into the civilian sector. It is important to
note that of the 1.7 million Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF)
Veterans eligible for Veteran Affairs (VA) services that only 58 percent (998,004) have ever
utilized these services. Second, such an approach does not take into consideration the
cumulative impact upon Veterans of losing the protective factors of leadership and social
support after they transition into the civilian sector and the compounding effect of
transitioning stressors upon Service Members. For example, it is possible that some Veterans
could be within a low-stable or resilience trajectory while experiencing the protective
factors of leadership and social support in the military but then worsen after these factors
dissipate and transitioning stressors take effect. In fact, a longitudinal study of National
Guard Service Members ascertained the impact of transitioning stressors (i.e., issues with
employment or financial difficulties, issues related to housing, and issues related to
marital and family problems) upon Veterans returning from combat and transitioning back into
the civilian sector. The study found that transitioning stressors were highly correlated with
psychological problems (i.e., PTSD, depression and alcohol dependence) and were more
associated with suicidal ideation than each of the psychological problems. In fact, after
adjusting for individual psychological problems, the odds of suicidal ideation among Veterans
experiencing the highest number of transitioning stressors were 5.4 times that of Veterans
experiencing no transitioning stressors. Additionally, Service Members who experienced a
divorce after deployment were at an even greater risk for suicidal ideation. The impact of
transitioning stressors may help to explain why 96 percent of a sample of 754 OEF/OIF
Veterans who sought care from the VA (between 2003 and 2007) expressed interest in receiving
services or information concerning transitioning problems. The most frequently reported
interests were related to Veteran Affairs benefits (83 percent of those surveyed) and
schooling, employment, or job training (80 percent of those surveyed).
These two reasons together may help to explain why the suicide rate for Veterans who do not
seek services from the VA, after transitioning into the civilian sector, has risen within the
last few years from approximately 34 per 100,000 in 2008 to approximately 39 per 100,000 in
2010. It appears that those most at risk are our youngest Veterans (18-24 year olds). The
suicide rate for young Veterans who used VA services spiked from 46.1 per 100,000 in 2009 to
79.1 per 100,000 in 2011. The investigators assume that the rate for our young Veterans who
haven't ever used VA services is even significantly higher. This means that among the 42
percent (726,054) of OEF/OIF Veterans who haven't ever used services could possibly be the
riskiest Veterans for suicide. This is a major concern of ours and constitutes what this
research study refers to as the "Deadly Gap", which consists of the time between military
service for a Veteran and their successful transition back into the civilian sector.
In trying to develop an intervention that addresses the concerns listed above, the
investigators reviewed already established programs within the military and successful
programs within the civilian sector. Of note, the investigators referenced the "Best
Practices Identified for Peer Support Programs" published by the Defense Centers of
Excellence for Psychological Health & Traumatic Brain Injury (TBI). Additionally, the U.S.
Army provides a mentor/sponsorship program (i.e., Total Army Transition Program) that assists
every Soldier to successfully navigate a Permanent Change of Station during which time a
Soldier transfers from one Army base to another. In this existing program, the sponsor
ensures that the Soldier transfers to the next duty station within such critical domains
as--employment/duty, housing, family, social/community/ physical activities, and medical
care. The sponsor doesn't provide services within each of these domains but instead guides
the transferring Soldiers and connects him or her to the organizations/individuals which do
provide these services. Unfortunately, no comprehensive system currently exists to enable
Service Members to execute their transition from the military to the civilian sector (or
"Expiration Term of Service"). The stressors that can result from transitions within any of
the domains can accumulate and acerbate pre-existing physical or psychological concerns,
especially suicide. The lack of such a program forces some transitioning Service Members to
navigate the "deadly gap" by themselves.
The investigators were also drawn to the successes of some programs for OEF/OIF Veterans at
institutions of higher learning. For the institutions that have been successful in
transitioning Veterans into academic life, it appears that they have focused on continuing
informal and formal leadership for the Veterans by--emphasizing positive interactions with
faculty and support personnel, providing peer mentors, establishing a social support
structure for the Veterans through connecting new Veteran students with other Veterans on
campus, and creating a cooperative network of Veteran service agencies (especially with the
VA) aimed at easing the transition for Veterans. It appears that such deliberate and
synchronized interventions are effective because they maintain positive protective
factors—leadership and social support—for transitioning Service Members and help to minimize
transitioning stressors. The investigators saw the opportunity to leverage the existing
informal social network established by the New York City Chapter of TM RWB to test a new
intervention, Pro Vetus. It capitalizes on the existing informal social support network
created by TM RWB, with the added intervention of formal social support and resources through
trained leadership provided by Pro Vetus.
With all of the above information, the investigators designed Pro Vetus upon the following
five principles to bridge the deadly gap:
1. Focused on Successful Transition of OEF/OIF Veterans to enable them to become the next
corporate and societal leaders (It is not an intervention based on a medical model of
treating disorders).
2. Focused on maximizing protective factors of leadership and social support for all
transitioning Veterans. Everyone could benefit from a trained mentor to assist in
navigating the "deadly gap."
3. Focused on short-term transition of Veterans to the civilian sector within the five
domains (employment/education, housing, family, social/community/physical activity, and
medical care)
4. Focused on establishing a supportive and collaborative environment for all agencies that
serve Veterans facilitated by capabilities provided by Unite Us and Google.
5. Focused on mentors establishing positive interpersonal relationships with recently
transitioned Veterans and their family members; Mentors are trained to provide "Buddy
Aid" (if necessary) and immediately connect Veterans to necessary services. Mentors
receive support from team leaders and the Department of VA Suicide Prevention
Coordinators to ensure they provide the best support possible to transitioned Veterans.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03384706 -
A Comparison of CPT Versus ART Versus WL
|
N/A | |
Completed |
NCT03418129 -
Neuromodulatory Treatments for Pain Management in TBI
|
N/A | |
Completed |
NCT03129204 -
Sensation Awareness Focused Training for Spouses
|
N/A | |
Recruiting |
NCT05651295 -
A Precision Medicine Approach to Target Engagement for Emotion Regulation
|
N/A | |
Completed |
NCT05113277 -
Development and Evaluation of a Tonic Immobility Focused Psychoeducational Intervention
|
N/A | |
Recruiting |
NCT05327504 -
Written Exposure Therapy for Veterans With SUD and PTSD
|
N/A | |
Recruiting |
NCT05843695 -
Enhancing Psychotherapy for Veterans and Service Members With PTSD and Anxiety
|
N/A | |
Active, not recruiting |
NCT05530642 -
An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel
|
N/A | |
Completed |
NCT00644423 -
Omega-3 Fatty Acids and Post Traumatic Stress Disorder (PTSD)
|
N/A | |
Completed |
NCT02989987 -
NET for SGBV Survivors in Eastern DR Congo
|
N/A | |
Completed |
NCT02320799 -
Randomized Controlled Trial of Interpersonal Psychotherapy for Depression and PTSD Among HIV+ Women in Kenya
|
N/A | |
Recruiting |
NCT02293291 -
Thermal Clinic Treatment in Gulf War Illness
|
Phase 1/Phase 2 | |
Completed |
NCT02242136 -
Treatment of Posttraumatic Stress Disorder and Aggressive Behavior in Soldiers and Ex-combatants
|
N/A | |
Completed |
NCT01911585 -
Efficacy of 60-minute Versus 90-minute Sessions in Treating PTSD Using Prolonged Exposure
|
N/A | |
Completed |
NCT02720497 -
The Efficacy of 90-Minute Versus 60-Minute Sessions of Prolonged Exposure for PTSD
|
N/A | |
Terminated |
NCT01408641 -
Topiramate for Alcohol Use in Posttraumatic Stress Disorder
|
N/A | |
Completed |
NCT01693978 -
Contingency Outcomes in Prolonged Exposure
|
N/A | |
Completed |
NCT01469754 -
Longitudinal Survey Analysis in Lymphoma Survivors
|
N/A | |
Completed |
NCT02362477 -
Telemental Health and Cognitive Processing Therapy for Female Veterans With Military-related PTSD
|
Phase 3 | |
Terminated |
NCT01239173 -
Emotional Memory Reactivation in Posttraumatic Stress Disorder
|
Phase 3 |