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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 (SERVE: IMPACT)

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ClinicalTrials.gov Identifier: NCT03615222
Recruitment Status : Active, not recruiting
First Posted : August 3, 2018
Last Update Posted : April 8, 2022
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:

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.


Condition or disease
PTSD Depression Chronic Pain Alcohol Use Disorder Traumatic Brain Injury

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Study Type : Observational
Actual Enrollment : 377 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : September 30, 2023


Group/Cohort
SERVE assessment only
Eligible veterans will complete 4 assessments over a two year period of time.



Primary Outcome Measures :
  1. Columbia suicide scale [ Time Frame: 2 year ]
    The Columbia Suicide Scale (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).

  2. Clinician Administered NSSI Disorder Index (CANDI) [ Time Frame: two years ]
    The 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.

  3. Beck Scale for Suicide Ideation (BSSI) [ Time Frame: 2 years ]
    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.

  4. World Health Organization Disability Assessment Schedule II (WHODAS 2.0) [ Time Frame: Two years ]
    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).

  5. Inventory of Psychosocial Functioning (IPF) - Brief [ Time Frame: two years ]
    Self-report measure (Co-I Marx et al., 2009; Bovin et al., 2018) of 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). Higher scores indicate greater functional impairment.

  6. Quality of life scale [ Time Frame: two years ]
    Self-report (Burkhardt, et al., 1989) assessing how satisfied people are in areas distinct from health status (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).


Biospecimen Retention:   Samples With DNA
blood, saliva optionally collected


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Veterans
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03615222


Locations
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United States, Texas
Central Texas Veterans Health Care System, Temple, TX
Temple, Texas, United States, 76504
Central Texas Veterans Health Care System Waco VA Medical Center, Waco, TX
Waco, Texas, United States, 76711
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Suzannah K. Creech, PhD Central Texas Veterans Health Care System, Temple, TX
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03615222    
Other Study ID Numbers: D0304-I
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: April 8, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Upon written request by qualified researchers and following institutional guidelines, deidentified data may be shared if the study participant consented to data sharing.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code
Time Frame: Within one year of completion of the study
Access Criteria: Upon written request by qualified researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
functional impairment
quality of life
Veterans
mindfulness
Acceptance and Commitment Therapy
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Chronic Pain
Alcoholism
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Pain
Neurologic Manifestations
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders