Alcohol Use Disorder, Chronic Pain, Depression, PTSD, Traumatic Brain Injury
Conditions
Keywords
functional impairment, quality of life, Veterans, mindfulness, Acceptance and Commitment Therapy
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.
Detailed description
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.
Interventions
None listed
Sponsors
VA Office of Research and Development
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Columbia Suicide Scale | Baseline and 24-month | 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. |
| World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) | Baseline, 8-month, 16-month, and 24-month | 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. |
| Clinician Administered NSSI Disorder Index (CANDI) | Baseline and 24-month | 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. |
| Inventory of Psychosocial Functioning (IPF) - Brief | Baseline, 8-month, 16-month, and 24-month | 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. |
| Beck Scale for Suicide Ideation (BSSI) | Baseline and 24-month | 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. |
| Quality of Life Scale | Baseline, 8-month, 16-month, and 24-month | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SERVE Assessment Only Eligible veterans will complete 4 assessments over a two year period of time. | 351 |
| Total | 351 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Ineligible | 26 |
| Overall Study | Withdrawal by Subject | 7 |
Baseline characteristics
| Characteristic | SERVE Assessment Only |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 11 Participants |
| Age, Categorical Between 18 and 65 years | 340 Participants |
| Age, Continuous | 46.20 years STANDARD_DEVIATION 9.08 |
| Alcohol Use Disorders Identification Test (AUDIT) | 3.54 units on a scale STANDARD_DEVIATION 5.12 |
| Drug Abuse Screening Test (DAST-10) | 1.13 units on a scale STANDARD_DEVIATION 0.97 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 60 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 291 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Patient Health Questionnaire (PHQ-9) | 10.09 units on a scale STANDARD_DEVIATION 6.56 |
| PTSD Checklist for DSM-5 (PCL-5) | 27.47 units on a scale STANDARD_DEVIATION 20.77 |
| Race (NIH/OMB) American Indian or Alaska Native | 6 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 103 Participants |
| Race (NIH/OMB) More than one race | 32 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 6 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants |
| Race (NIH/OMB) White | 187 Participants |
| Region of Enrollment United States | 351 Participants |
| Sex: Female, Male Female | 105 Participants |
| Sex: Female, Male Male | 246 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 351 |
| other Total, other adverse events | 0 / 351 |
| serious Total, serious adverse events | 25 / 351 |
Outcome results
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.
Time frame: Baseline and 24-month
Population: Differences in participants reflect number completed at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SERVE Assessment Only | Beck Scale for Suicide Ideation (BSSI) | Baseline | 1.99 score on a scale | Standard Deviation 4.66 |
| SERVE Assessment Only | Beck Scale for Suicide Ideation (BSSI) | 24-month | 1.61 score on a scale | Standard Deviation 4.16 |
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.
Time frame: Baseline and 24-month
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SERVE Assessment Only | Clinician Administered NSSI Disorder Index (CANDI) | Baseline - Lifetime NSSID | 31 Participants |
| SERVE Assessment Only | Clinician Administered NSSI Disorder Index (CANDI) | Baseline - Current NSSID | 8 Participants |
| SERVE Assessment Only | Clinician Administered NSSI Disorder Index (CANDI) | 24-month - Current NSSID | 5 Participants |
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.
Time frame: Baseline and 24-month
Population: Analysis at 24-month includes the 216 participants who completed the clinical assessment at follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SERVE Assessment Only | Columbia Suicide Scale | Baseline | 1.19 score on a scale | Standard Deviation 3.76 |
| SERVE Assessment Only | Columbia Suicide Scale | 24-month | 1.09 score on a scale | Standard Deviation 3.67 |
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.
Time frame: Baseline, 8-month, 16-month, and 24-month
Population: Differences in participants reflect number completed at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SERVE Assessment Only | Inventory of Psychosocial Functioning (IPF) - Brief | Baseline | 44.96 score on a scale | Standard Deviation 23.06 |
| SERVE Assessment Only | Inventory of Psychosocial Functioning (IPF) - Brief | 8-month | 48.02 score on a scale | Standard Deviation 22.64 |
| SERVE Assessment Only | Inventory of Psychosocial Functioning (IPF) - Brief | 16-month | 46.04 score on a scale | Standard Deviation 22.85 |
| SERVE Assessment Only | Inventory of Psychosocial Functioning (IPF) - Brief | 24-month | 39.89 score on a scale | Standard Deviation 23.46 |
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.
Time frame: Baseline, 8-month, 16-month, and 24-month
Population: Differences in participants reflect number completed at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SERVE Assessment Only | Quality of Life Scale | Baseline | 75.03 score on a scale | Standard Deviation 18.39 |
| SERVE Assessment Only | Quality of Life Scale | 8-month | 72.09 score on a scale | Standard Deviation 18.35 |
| SERVE Assessment Only | Quality of Life Scale | 16-month | 73.38 score on a scale | Standard Deviation 18.9 |
| SERVE Assessment Only | Quality of Life Scale | 24-month | 76.56 score on a scale | Standard Deviation 19.18 |
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.
Time frame: Baseline, 8-month, 16-month, and 24-month
Population: Differences in participants reflect number completed at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SERVE Assessment Only | World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) | Baseline | 1.20 score on a scale | Standard Deviation 0.8 |
| SERVE Assessment Only | World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) | 8-month | 1.28 score on a scale | Standard Deviation 0.77 |
| SERVE Assessment Only | World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) | 16-month | 1.21 score on a scale | Standard Deviation 0.8 |
| SERVE Assessment Only | World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) | 24-month | 1.03 score on a scale | Standard Deviation 0.79 |