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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.
Research by the investigators' team and others demonstrates that posttraumatic stress disorder (PTSD), depression, alcohol use disorders (AUD), traumatic brain injury (TBI), and chronic pain frequently co-occur among post-9/11 war Veterans and are associated with functional impairment and suicide risk; however, no treatment currently exists that has been specifically designed to promote functional recovery among Veterans experiencing any combination of these most common mental and physical wounds of war. The investigative team has: (A) identified multiple modifiable psychosocial factors (emotion regulation, psychological flexibility, self-compassion) that prospectively predict impairment and suicidal ideation in Veterans; (B) characterized long-term trajectories of resilience and functional disability in Veterans; (C) determined that high utilization of VA mental health services appears to have little, if any, impact on the functional recovery of Veterans on the moderate and severely impaired trajectories; (D) identified psychological flexibility (i.e., the ability to remain present in the moment despite emotional distress and to persist in changing behavior in the pursuit of one's values and goals) as a unique, prospective predictor of membership in the severely impaired functional trajectory and of suicidal ideation, even after accounting for the effects of co-morbidity; and (E) demonstrated that Acceptance and Commitment Therapy (ACT)-a trans-diagnostic, mindfulness-based behavior therapy that seeks to improve functioning by targeting psychological flexibility -can lead to recovery, including sustained improvements in functional disability, quality of life (QoL), suicidal ideation, PTSD, and AUD symptoms among severely impaired Veterans with co-occurring PTSD-AUD.
This study is Phase 3 of Project SERVE (Study Evaluating Returning Veterans' Experiences). Through two prior RR&D MERIT awards, 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SERVE assessment only | Eligible veterans will complete 4 assessments over a two year period of time. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
The inclusion criteria for the longitudinal assessment study are as follows:
To be eligible, participants must be
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
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:
Additional inclusion criteria specific to the SCD treatment study are:
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:
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
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
Additional diagnoses of non-alcohol SUD are allowed, unless they are deemed the principal focus of treatment.
Potentially eligible Veterans who score above the clinical cutoff on the DAST will be asked additional questions during the eligibility screening to determine whether they meet criteria for a principal non-alcohol SUD (see phone screen)
AUD/SUD of sufficient severity that residential, rather than outpatient, treatment is indicated based on potential safety concerns associated with withdrawal.
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Veterans
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| Name | Affiliation | Role |
|---|---|---|
| Suzannah K. Creech, PhD | Central Texas Veterans Health Care System, Temple, TX | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Texas Veterans Health Care System, Temple, TX | Temple | Texas | 76504-7451 | United States | ||
| Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX |
Upon written request by qualified researchers and following institutional guidelines, deidentified data may be shared if the study participant consented to data sharing.
Within one year of completion of the study
Upon written request by qualified researchers
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| ID | Title | Description |
|---|---|---|
| FG000 | SERVE Assessment Only | Eligible veterans will complete 4 assessments over a two year period of time. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Analyses include only eligible participants (n=351).
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| ID | Title | Description |
|---|---|---|
| BG000 | SERVE Assessment Only | Eligible veterans will complete 4 assessments over a two year period of time. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Analysis at 24-month includes the 216 participants who completed the clinical assessment at follow-up. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 24-month |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SERVE Assessment Only | Eligible veterans will complete 4 assessments over a two year period of time. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mental Health Hospitalization | Psychiatric disorders | Non-systematic Assessment | Hospitalized following an increase of mental health symptoms and/or suicide attempt |
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Due to COVID-19 there was a pause in data collection which lead to fewer participants than originally targeted.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Suzannah Creech | CTX VA | 254-654-7241 | suzannah.creech@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 13, 2023 | Aug 29, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 5, 2020 | Aug 29, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D003863 | Depression |
| D059350 | Chronic Pain |
| D000437 | Alcoholism |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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blood, saliva optionally collected
| 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 |
| Waco |
| Texas |
| 76711 |
| United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| PTSD Checklist for DSM-5 (PCL-5) | Self-report of symptoms of PTSD during the previous month. Demonstrates high sensitivity and specificity in relation to a lengthy diagnostic interview for PTSD (CAPS), with which it was co-developed. Total scores range from 0 to 80 with higher scores indicating more symptoms of PTSD. Provisional PTSD diagnosis 33+. | Mean | Standard Deviation | units on a scale |
|
| Alcohol Use Disorders Identification Test (AUDIT) | Self-report measure to screen for alcohol-use disorders (Saunders, Aasland, Babor, Fuente, & Grant, 1993). 10-item measure adopted by VA as the gold-standard screening for alcohol use disorders in mental health and primary care clinics. Good internal consistency (α=.80-.94) and test-retest reliability (r=.86), and strong concurrent validity with the MAST and CAGE screening measures (Babor et al., 2001). Total scores range from 0 to 40 with higher scores indicating more problematic drinking behavior. Non-drinker (0); Hazardous/Harmful Alcohol Consumption (8-14); Provisional AUD diagnosis (15+). | Mean | Standard Deviation | units on a scale |
|
| Drug Abuse Screening Test (DAST-10) | Self-report measure to quantify drug misuse and related psychosocial impairment. Good internal consistency and concurrent validity with frequency of drug use over 12-months (Skinner, 1982). Moderately correlated with denial and social desirability. The instructions will be updated to more explicitly assess for misuse of opiates that may have been prescribed. Total scores range from 0 to 10 with higher scores indicating more problems with drug use. No problems (0); Low level (1-2); Moderate level (3-5); Substantial level (6-8); Severe level (9-10). | Mean | Standard Deviation | units on a scale |
|
| Patient Health Questionnaire (PHQ-9) | Self-report measure used for screening, diagnosing, and monitoring depression. It incorporates DSM-V diagnostic criteria (Question 9 screens for suicidal ideation; Kroenke, Spitzer & Williams, 2001). Total scores range from 0 to 27 with higher scores indicating more symptoms of depression. Mild (5-9); Moderate (10-14); Moderately Severe (15-19); Severe (20-27). | Mean | Standard Deviation | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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. | Differences in participants reflect number completed at each timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 8-month, 16-month, and 24-month |
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | Baseline and 24-month |
|
|
|
| Primary | 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. | Differences in participants reflect number completed at each timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 8-month, 16-month, and 24-month |
|
|
|
| Primary | 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. | Differences in participants reflect number completed at each timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 24-month |
|
|
|
| Primary | 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. | Differences in participants reflect number completed at each timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 8-month, 16-month, and 24-month |
|
|
|
| 1 |
| 351 |
| 25 |
| 351 |
| 0 |
| 351 |
|
| Jailed | General disorders | Non-systematic Assessment | Reported being jailed overnight |
|
| Minor Surgery | General disorders | Non-systematic Assessment | Overnight hospitalization for minor surgery |
|
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| D001519 | Behavior |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
|
| 16-month |
|
|
| 24-month |
|
|
| Title | Measurements |
|---|
|
|
| 16-month |
|
|
| 24-month |
|
|
|
|
| 16-month |
|
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| 24-month |
|
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