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Project SERVE: Post Deployment Functioning

Functional Outcomes in OEF/OIF Veterans With PTSD and Alcohol Misuse

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01123642
Enrollment
345
Registered
2010-05-14
Start date
2010-10-31
Completion date
2014-09-30
Last updated
2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcoholism, Depressive Disorder, Post-traumatic Stress Disorder

Keywords

post-traumatic stress disorder, depressive disorder, alcoholism, Longitudinal studies, readjustment

Brief summary

Functional recovery is of the utmost importance to evaluate in our returning Operation Enduring and Iraqi Freedom Veterans so that we can better understand their needs and experiences during the readjustment process from warzone to civilian life. Although most soldiers are resilient, concerning rates of PTSD (12-20%) and depression (14-15%) have been found, and as many as 24-35% report drinking more alcohol than they intended (Hoge et al., 2004). The current study proposes to follow returning Veterans for a one-year period to evaluate factors that influence the readjustment process and functional impairment. This information should guide the development of early intervention and treatment programs to help recovery.

Detailed description

The proposed longitudinal study aims to better understand the functioning of returning Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF) OEF/OIF Veterans over time and to identify potentially malleable resilience factors associated with higher levels of functioning. A total of 300 returning OEF/OIF Veterans will be followed for a one-year period. Veterans will complete a baseline assessment, followed by three follow-up assessments (two self-report assessments mailed at 4- and 8-months post-baseline and a one-year in-person follow-up assessment that repeats many of the baseline clinician-administered assessments). Multiple functional outcomes will be evaluated, including occupational, family, social, and physical functioning. The specific aims include: 1) identifying whether a dose-response relationship exists between level of exposure to stressors (pre-deployment, deployment-related, and post-deployment) and functioning over time; 2) examining whether potentially malleable resilience factors predict higher levels of functioning in returning Veterans over time; 3) examining whether psychopathology predicts lower levels of functioning in returning Veterans over time; 4) testing the theoretical model that psychopathology partially mediates the effects of stress, social support, coping, and neurocognition on functioning over time; 5) examining whether changes in the use of healthy coping strategies, social support, post-deployment stress, and psychopathology predict changes in functioning over time; and 6) exploring whether stress, social support, coping, neurocognition, and psychopathology have differential effects on specific aspects of functioning (e.g., occupational, family, social, and physical functioning) over time. The long-term aim of this research is to develop evidence-based early intervention and treatment programs designed to assist returning OEF/OIF Veterans with achieving optimal functioning when reintegrating into civilian life. In keeping with the VHA's goal of operationalizing principles of recovery and rehabilitation in treatment planning, this research should provide a platform of empirical data to assist with the further development of meaningful early intervention and treatment programs to assist OEF/OIF Veterans with the post-war readjustment process over time.

Interventions

None listed

Sponsors

Texas A&M University
CollaboratorOTHER
Boston University
CollaboratorOTHER
VA Office of Research and Development
Lead SponsorFED

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

To be eligible, participants must be: * enrolled returning OEF/OIF Veteran within CTVHCS; * English-speaking Veterans; * 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; * deemed stable on psychotropic medications and in psychotherapy.

Exclusion criteria

Veterans will be excluded if they: * plan to relocate out of the Central Texas area within four months of protocol initiation; * meet criteria for a diagnoses of schizophrenia, other psychotic disorders, or bipolar disorder; * report current hallucinations or delusions that are clearly not trauma-related; or * report current suicidal or homicidal risk warranting crisis intervention.

Design outcomes

Primary

MeasureTime frameDescription
World Health Organization Disability Assessment Schedule II (WHODAS II)one yearParticipants complete the WHODAS II at baseline, 4 months, 8 months, and 12 months. The WHODAS II measures general disability related to multiple domains (i.e., understanding and communicating, getting around, self care, getting along with people, life activities, work/school, participation in society). Total scores range from 1 (no disability) to 5 (extreme/cannot do), with higher scores indicating more impairment.

Secondary

MeasureTime frameDescription
Inventory of Psychosocial Functioning (IPF)one year80-item self-report measure of psychosocial functioning across multiple domains (e.g., family, social, day-to-day activities). Items are rated on a 7-point scale ranging from 0 (never) to 6 (always). Lower scores indicate more positive outcomes.
Quality of Life Scale (QLS)one yearQuality of life measure of functioning scored on a 1 (delighted) to 7 (terrible) scale. Scores are summed with higher scores indicating lower quality of life. Total scores range from 16 - 112.
Clinician Administered PTSD Scale (CAPS-5)one yearTotal scores reflecting PTSD symptom severity. Scores ranging from 0-136 (higher score = more severe).

Countries

United States

Participant flow

Pre-assignment details

A total of 345 participants were consented into the study, after which final eligibility was determined during the baseline assessment (see inclusion/exclusion criteria). Of the 345 enrolled, 309 met inclusion criteria and were deemed eligible for follow-up in the longitudinal study.

Participants by arm

ArmCount
OEF/OIF/OND Veterans
Operations Enduring Freedom, Iraqi Freedom and New Dawn Veterans
309
Total309

Withdrawals & dropouts

PeriodReasonFG000
Overall Studyineligible at baseline assessment36
Overall StudyLost to Follow-up23
Overall StudyWithdrawal by Subject9

Baseline characteristics

CharacteristicOEF/OIF/OND Veterans
Age, Continuous38.81 years
STANDARD_DEVIATION 9.81
Sex: Female, Male
Female
100 Participants
Sex: Female, Male
Male
209 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
2 / 309
serious
Total, serious adverse events
28 / 309

Outcome results

Primary

World Health Organization Disability Assessment Schedule II (WHODAS II)

Participants complete the WHODAS II at baseline, 4 months, 8 months, and 12 months. The WHODAS II measures general disability related to multiple domains (i.e., understanding and communicating, getting around, self care, getting along with people, life activities, work/school, participation in society). Total scores range from 1 (no disability) to 5 (extreme/cannot do), with higher scores indicating more impairment.

Time frame: one year

Population: A total of 345 participants were enrolled, of which 309 were deemed eligible. Analyses are conducted with the total sample N = 309, followed over time. Sample sizes vary over time due to attrition and missing data.

ArmMeasureGroupValue (MEAN)Dispersion
OEF/OIF/OND VeteransWorld Health Organization Disability Assessment Schedule II (WHODAS II)Baseline1.87 units on a scaleStandard Deviation 0.69
OEF/OIF/OND VeteransWorld Health Organization Disability Assessment Schedule II (WHODAS II)4 months2.03 units on a scaleStandard Deviation 0.77
OEF/OIF/OND VeteransWorld Health Organization Disability Assessment Schedule II (WHODAS II)8 months2.07 units on a scaleStandard Deviation 0.78
OEF/OIF/OND VeteransWorld Health Organization Disability Assessment Schedule II (WHODAS II)12 months1.88 units on a scaleStandard Deviation 0.73
Secondary

Clinician Administered PTSD Scale (CAPS-5)

Total scores reflecting PTSD symptom severity. Scores ranging from 0-136 (higher score = more severe).

Time frame: one year

Population: Sample sizes differ across time points due to attrition and missing data.

ArmMeasureGroupValue (MEAN)Dispersion
OEF/OIF/OND VeteransClinician Administered PTSD Scale (CAPS-5)Baseline29.71 score on a scaleStandard Deviation 27.49
OEF/OIF/OND VeteransClinician Administered PTSD Scale (CAPS-5)12 months34.29 score on a scaleStandard Deviation 30.94
Secondary

Inventory of Psychosocial Functioning (IPF)

80-item self-report measure of psychosocial functioning across multiple domains (e.g., family, social, day-to-day activities). Items are rated on a 7-point scale ranging from 0 (never) to 6 (always). Lower scores indicate more positive outcomes.

Time frame: one year

Population: Sample sizes differ due to attrition and missing data.

ArmMeasureGroupValue (MEAN)Dispersion
OEF/OIF/OND VeteransInventory of Psychosocial Functioning (IPF)Baseline2.51 score on a scaleStandard Deviation 1.25
OEF/OIF/OND VeteransInventory of Psychosocial Functioning (IPF)12 months2.33 score on a scaleStandard Deviation 1.19
Secondary

Quality of Life Scale (QLS)

Quality of life measure of functioning scored on a 1 (delighted) to 7 (terrible) scale. Scores are summed with higher scores indicating lower quality of life. Total scores range from 16 - 112.

Time frame: one year

Population: Sample sizes differ due to attrition and missing data.

ArmMeasureGroupValue (MEAN)Dispersion
OEF/OIF/OND VeteransQuality of Life Scale (QLS)Baseline76.33 score on a scaleStandard Deviation 17.46
OEF/OIF/OND VeteransQuality of Life Scale (QLS)4 months73.04 score on a scaleStandard Deviation 20.2
OEF/OIF/OND VeteransQuality of Life Scale (QLS)8 months72.38 score on a scaleStandard Deviation 20.6
OEF/OIF/OND VeteransQuality of Life Scale (QLS)12 months77.59 score on a scaleStandard Deviation 18.31

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026