Clinical trial NCT03615222: Impact of Modifiable Psychosocial Factors on Veterans' Long-term Trajectories of Functioning and Quality of Life
Official title: The Impact of Modifiable Psychosocial Factors on Veterans' Long-term Trajectories of Functioning and Quality of Life: Promoting Recovery by Targeting Mindfulness and Psychological Flexibility
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PTSD
Depression
Chronic Pain
Alcohol Use Disorder
Traumatic Brain Injury
Keywords: functional impairment
quality of life
Veterans
mindfulness
Acceptance and Commitment Therapy
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2018-08-03
Enrollment: 377
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Veterans

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.

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.
* 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.

  * This determination will be made by the PI, with consultation from the Veteran's existing treatment providers, as appropriate.

Primary outcomes:
measure: Columbia Suicide Scale
timeFrame: Baseline and 24-month
measure: World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
timeFrame: Baseline, 8-month, 16-month, and 24-month
measure: Clinician Administered NSSI Disorder Index (CANDI)
timeFrame: Baseline and 24-month
measure: Inventory of Psychosocial Functioning (IPF) - Brief
timeFrame: Baseline, 8-month, 16-month, and 24-month
measure: Beck Scale for Suicide Ideation (BSSI)
timeFrame: Baseline and 24-month
measure: Quality of Life Scale
timeFrame: Baseline, 8-month, 16-month, and 24-month
Secondary outcomes:
Other outcomes:
Locations:
city: Temple
country: United States
facility: Central Texas Veterans Health Care System, Temple, TX
state: Texas
city: Waco
country: United States
facility: Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX
state: Texas
Study officials:
affiliation: Central Texas Veterans Health Care System, Temple, TX
name: Suzannah K. Creech, PhD
role: PRINCIPAL_INVESTIGATOR
References: