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NCT03615222 · ClinicalTrials.gov registry record
Impact of Modifiable Psychosocial Factors on Veterans' Long-term Trajectories of Functioning and Quality of Life
A clinical trial, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- 377
- Enrollment target
NCT03615222: Completed study, sponsored by VA Office of Research and Development.
NCT03615222 is a clinical trial that has completed, run by VA Office of Research and Development. The registered enrollment target is 377 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03615222 has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- 377 participants
- Enrollment target
Study 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.
Primary Outcome
The Columbia Suicide Severity Rating Scale (C-SSRS; Posner et al., 2008) is a state-of-the-art suicide assessment for individuals perceived to be at high risk for suicidality. Internal consistency ranged from .73 to .95 (Posner et al., 2011). Values on the intensity of suicidal ideation (e.g., frequency, duration, controllability, deterrents, reasons for ideation) are summed to create a total score; range from 0 to 25, where higher scores indicate higher SI severity.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 377 participants |
| Start Date | 2018-10-01 |
| Est. Completion | 2023-09-30 |
What the finished NCT03615222 record still lists
NCT03615222 is an observational study that tracks outcomes without assigning an intervention. The registered 377 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT03615222 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03615222 about?
NCT03615222 is a clinical study titled "Impact of Modifiable Psychosocial Factors on Veterans' Long-term Trajectories of Functioning and Quality of Life". 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-t...
What is the current status of trial NCT03615222?
This trial is currently completed. The enrollment target is 377 participants. The study started on 2018-10-01. Estimated completion is 2023-09-30.
Who is sponsoring clinical trial NCT03615222?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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