N/A
N=377
Impact of Modifiable Psychosocial Factors on Veterans' Long-term Trajectories of Functioning and Quality of Life
PTSD · Depression · Chronic Pain · Alcohol Use Disorder · Traumatic Brain Injury
Bottom Line
View on ClinicalTrials.gov: NCT03615222 ↗Enrolled (actual)
377
Serious AEs
7.1%
Results posted
Oct 2024
Primary outcome: Primary: Columbia Suicide Scale — 1.19; 1.09 score on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Columbia Suicide Scale |
1.19; 1.09 | — |
| PRIMARY World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) |
1.20; 1.28; 1.21; 1.03 | — |
| PRIMARY Clinician Administered NSSI Disorder Index (CANDI) |
31; 8; 5 | — |
| PRIMARY Inventory of Psychosocial Functioning (IPF) - Brief |
44.96; 48.02; 46.04; 39.89 | — |
| PRIMARY Beck Scale for Suicide Ideation (BSSI) |
1.99; 1.61 | — |
| PRIMARY Quality of Life Scale |
75.03; 72.09; 73.38; 76.56 | — |
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.
Eligibility Criteria
Inclusion Criteria
The inclusion criteria for the longitudinal assessment study are as follows:
- Potential participants include male and female
- English-speaking OEF/OIF/OND Veterans
- Enrolled at CTVHCS or willing to be enrolled for the purpose of participation in this study.
To be eligible, participants must be
- able to comprehend and sign the informed consent form
- able to complete the structured interviews and self-report assessments
- willing to be contacted for follow-up assessments
For newly enrolled participants:
- given that the investigators have already recruited a large sample of veterans who are reporting relatively little functional impairment, the investigators will require newly enrolled participants to self-report global functional impairment on the WHODAS 2.0 12-item self-report version equivalent to a mean item score of 1.0.
- Although the investigators anticipate being able to meet the recruitment goals, should recruitment prove more challenging than expected, the investigators will remove this inclusion criterion
- deemed stable on psychotropic medications (defined as 3 months on a selective serotonin reuptake inhibitor or monoamine oxidase inhibitor; >1 month on an anxiolytic or beta-blocker; >1 month medication discontinuation or "wash out" for all medications) at the time of the BL assessment
- deemed stable in psychotherapy (3 months stabilization for psychotherapy and 1-month psychotherapy wash-out) at the time of the BL assessment
- These latter two criteria are instated to ensure that symptoms assessed during the baseline assessment are due to any underlying psychiatric condition and not due to the effects of starting or stopping medications and/or psychotherapy.
- Changes in treatment will be permissible during the current study, as this reflects real-world practice
- All changes in medications will be monitored over time, and appropriately covaried, as treatment can have important effects on functioning over time
- Individuals will be eligible to participate with current and lifetime psychiatric diagnoses, with the exception of:
- schizophrenia
- schizophreniform disorder
- schizoaffective disorder
- delusional disorder
- unspecified schizophrenia spectrum/other psychotic disorder, and bipolar disorder
Additional inclusion criteria specific to the SCD treatment study are:
- Veterans will have a global disability (mean item) score on the WHODAS 2.0 of 1.0, which is 1 SD above the mean of the large non-psychiatric sample of Veterans from SERVE and VA Boston during both of their last 2 assessments
Exclusion Criteria
Exclusion criteria for the longitudinal assessment study are as follows:
- plan to relocate out of the CTVHCS system within four months of protocol initiation
- meet criteria for a diagnosis of:
- schizophrenia
- schizophreniform disorder
- schizoaffective disorder
- delusional disorder
- a manic/hypomanic episode
- report current suicidal or homicidal risk warranting crisis intervention
- report symptoms consistent with severe traumatic brain injury (TBI) that interfere with their ability to complete the consent process or assessment
- i.e., due to ethical concerns about obtaining informed consent and difficulties with completing the structured assessment
- report current non-military related hallucinations or delusions that cause significant distress and/or impairment
Additional exclusion criteria for the SCD treatment study are:
- recent (1 month) or anticipated change in psycho-pharmacological treatment. Veterans may stay on current medications but will be asked to refrain from changes to the extent possible based on safety
- logistical circumstances that would interfere with study completion
- Presence of a non-alcohol substance use disorder (SUD) deemed to be the primary focus of treatment
- Those with a principal AUD will be eligible.
- Additional diagnoses of non-alcohol SUD are allowed, unless they are deemed the principal focus of treatment.
- Potentiall
Data sourced from ClinicalTrials.gov (NCT03615222). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.