Impact of Modifiable Psychosocial Factors on Veterans' Long-term Trajectories of Functioning and Quality of Life

NCT03615222 | Completed Results

• 1 other identifier: D0304-I
• Study Type: observational
• Target: 377
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

PTSD; Depression; Chronic Pain; Alcohol Use Disorder; Traumatic Brain Injury

Keywords

functional impairment; quality of life; Veterans; mindfulness; Acceptance and Commitment Therapy

Outcome Measures

Primary Outcomes (6)

• Columbia Suicide Scale

  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.

  Baseline and 24-month

• World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)

  Self-report assessment of functional disability with total score and 6 domains of functioning: understanding and communicating, mobility, getting along with others, life activities (i.e., work, education, household responsibilities), participation in society, and self-care (Ustun et al., 2010). Both global and specific areas of functioning are crucial in thoroughly understanding functional recovery, as Veterans may function well in one area and have difficulty in another. Moreover, some domains may be affected by contextual factors instead of representing functional capacity (e.g., work functioning in a struggling economy independent of impairment). Means on this measure capture items from all domain subscales and can range from 0 to 3 where higher scores indicate higher levels of disability.

  Baseline, 8-month, 16-month, and 24-month

• Clinician Administered NSSI Disorder Index (CANDI)

  The Clinician Administered NSSI Disorder Index (CANDI) is a clinical interview that diagnoses Nonsuicidal Self Injury (NSSI) disorder and type and frequency of NSSI. Demonstrated good reliability and validity in prior research. Results report the number of participants that meet for a diagnosis of NSSID.

  Baseline and 24-month

• Inventory of Psychosocial Functioning (IPF) - Brief

  Self-report measure (Marx et al., 2009; Bovin et al., 2018) of problems in different domains of life (e.g., Romantic Relationships with a Spouse/Partner, Family, Work, Friendships and Socializing, Parenting, Education, and Self-Care). The short version has a .90 correlation with the full 80-item instrument (Co-I Marx, personal communication). Adjusted totals range from 0 to 100 with higher scores indicate greater functional impairment.

  Baseline, 8-month, 16-month, and 24-month

• Beck Scale for Suicide Ideation (BSSI)

  Widely-used self-report measure of intensity of thoughts and behaviors associated with suicide. Includes 2 additional items that ask about past suicide attempts as well as the level of suicidal intent during the most recent attempt. Prior research shows that endorsement of suicidal thoughts and behaviors can be greater on self-report questionnaires compared to interviews. Total scores range from 0 to 42 where higher scores indicate higher suicidal ideation.

  Baseline and 24-month

• Quality of Life Scale

  Self-report (Burkhardt, et al., 1989) assessing how satisfied people are in different areas of their life, distinct from health status, (e.g., mate, physical well-being, relationships with others, social, community, and civic activities, personal development and fulfillment, recreation, and independence). Good internal consistency and high test-retest reliability (Burckhardt et al. 2003). Total scores range from 16 to 112 with higher scores indicating greater life satisfaction.

  Baseline, 8-month, 16-month, and 24-month

Study Arms (1)

SERVE assessment only

Eligible veterans will complete 4 assessments over a two year period of time.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Veterans

You may qualify if:

• 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.
• 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:

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

Central Texas Veterans Health Care System, Temple, TX

Temple, Texas, 76504-7451, United States

Location

Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX

Waco, Texas, 76711, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood, saliva optionally collected

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression; Chronic Pain; Alcoholism; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Limitations and Caveats

Due to COVID-19 there was a pause in data collection which lead to fewer participants than originally targeted.

Results Point of Contact

• Title: Suzannah Creech
• Organization: CTX VA

suzannah.creech@va.gov

254-654-7241

Study Officials

• Suzannah K. Creech, PhD

  Central Texas Veterans Health Care System, Temple, TX

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2018
• First Posted: August 3, 2018
• Study Start: October 1, 2018
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: October 24, 2024
• Results First Posted: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Within one year of completion of the study
• Access Criteria: Upon written request by qualified researchers

Locations

US (2)