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Clinical Trial Summary

Research by the investigators' team and others demonstrates that posttraumatic stress disorder (PTSD), depression, alcohol use disorders (AUD), traumatic brain injury (TBI), and chronic pain frequently co-occur among post-9/11 war Veterans and are associated with functional impairment and suicide risk; however, no treatment currently exists that has been specifically designed to promote functional recovery among Veterans experiencing any combination of these most common mental and physical wounds of war. The investigative team has: (A) identified multiple modifiable psychosocial factors (emotion regulation, psychological flexibility, self-compassion) that prospectively predict impairment and suicidal ideation in Veterans; (B) characterized long-term trajectories of resilience and functional disability in Veterans; (C) determined that high utilization of VA mental health services appears to have little, if any, impact on the functional recovery of Veterans on the moderate and severely impaired trajectories; (D) identified psychological flexibility (i.e., the ability to remain present in the moment despite emotional distress and to persist in changing behavior in the pursuit of one's values and goals) as a unique, prospective predictor of membership in the severely impaired functional trajectory and of suicidal ideation, even after accounting for the effects of co-morbidity; and (E) demonstrated that Acceptance and Commitment Therapy (ACT)-a trans-diagnostic, mindfulness-based behavior therapy that seeks to improve functioning by targeting psychological flexibility -can lead to recovery, including sustained improvements in functional disability, quality of life (QoL), suicidal ideation, PTSD, and AUD symptoms among severely impaired Veterans with co-occurring PTSD-AUD.

This study is Phase 3 of Project SERVE (Study Evaluating Returning Veterans' Experiences). Through two prior RR&D MERIT awards, SERVE has followed a cohort of post-9/11 Veterans since 2010 and has identified numerous risk and protective factors. SERVE's overall objective is to understand and improve the long-term functional outcomes of post-9/11 Veterans. Consistent with the investigators' conceptual model, the central hypothesis is that psychological flexibility and other trans-diagnostic treatment targets mediate the effects of the most common mental and physical wounds of war on long-term functioning and self-directed violence (i.e., suicide risk). Thus, integrated interventions specifically designed to improve functioning associated with these conditions are most likely to promote long-term recovery among the most impaired Veterans. The investigators will test the central hypothesis and accomplish the overall objective by pursuing the following specific aims:

Aim 1: Identify treatment targets that prospectively predict functional disability and self-directed violence (SDV) in post-9/11 Veterans with PTSD, depression, chronic pain, TBI, and/or AUD.

To achieve this aim, the investigators will follow 500 Veterans for 2 years in order to prospectively evaluate the impact of several novel, treatment-relevant factors on functional disability and SDV over time.

H1: Novel factors (mindfulness, perceived burdensomeness, thwarted belongingness, and moral injury) along with established treatment targets (psychological flexibility, self-compassion, and emotion regulation) will prospectively predict functional disability and SDV after accounting for covariates.

Aim 2: Develop, refine, and evaluate the feasibility and acceptability of a transdiagnostic, personalized ACT-based behavioral therapy (ACT-FX) specifically designed to improve functioning in Veterans.

The investigators will use the Successive Cohort Design method to refine ACT-FX. The investigators will then evaluate the feasibility and acceptability of ACT-FX in 60 Veterans randomly assigned to ACT-FX or treatment as usual (TAU) and who will remain in the longitudinal assessment study (Aim 1) for long-term follow-ups.

H2: ACT-FX will be feasible and acceptable to Veterans with complex mental and physical wounds of war.

Aim 3: (Exploratory) Evaluate if participation in ACT-FX leads to the emergence of a new trajectory class among Veterans in Project SERVE that is characterized by long-term functional recovery.

H3: ACT-FX treatment will predict membership in a new trajectory class characterized by functional recovery compared to Veterans receiving TAU who will continue to exhibit flat or worsening trajectories.

Impact: The proposed research will help identify novel modifiable factors for functional recovery and provide proof-of-concept, within the context of the longitudinal study, that ACT-FX promotes recovery. This innovative project has potential to advance VA healthcare by promoting long-term functional recovery in Veterans.

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT03615222
Study type Interventional
Source VA Office of Research and Development
Status Enrolling by invitation
Phase Phase 1/Phase 2
Start date October 1, 2018
Completion date September 30, 2022

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