CI

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ClinicalIndex Comparison Record
N/ACompleted· 377 enrolled
Drug / intervention
Not specified
Likely dose
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Search/NCT03615222
NCT03615222N/ACompleted

The Impact of Modifiable Psychosocial Factors on Veterans' Long-term Trajectories of Functioning and Quality of Life: Promoting Recovery by Targeting Mindfulness and Psychological Flexibility

VA Office of Research and Development·observational·Posted Aug 3, 2018·Updated Oct 24, 2024

In Brief

An observational study for PTSD and 4 related conditions. Completed, enrolled 377 participants across 2 sites.

Detailed Summary

This study is Phase 3 of Project SERVE (Study Evaluating Returning Veterans' Experiences). Through two prior phases, 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, family functioning 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedAug 3, 2018
Enrollment StartOct 1, 2018
Primary CompletionSep 30, 2023
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 7.9 years ago