Clinical trial NCT05020587: Consulting After Combat: Interviewing Veterans to Develop a Therapy to Restore Functioning and Reintegration After Moral Injury Events
Official title: Consulting After Combat: Interviewing Service Members and Veterans to Develop a Therapy to Restore Functioning and Reintegration After Moral Injury Events
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Moral Injury
Functional Impairment
Keywords: Moral Injury
Group Psychotherapy
Veterans
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2021-08-25
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Two open pilot trials of a novel time-limited potentially morally injurious event (PMIE)-focused therapy group (N \~= 12), led by two therapists.
Primary purpose: TREATMENT

Brief summary: Despite the VA's best efforts to treat the psychosocial impact of war, many combat Veterans report lingering difficulty reintegrating into meaningful post-deployment lives. War is among the most extreme forms of human experience but, for many, wartime trauma was treated using models transported from civilian single-incident trauma contexts. Veterans have unique needs and experiences that require culturally responsive and sensitive conceptualizations and treatments. Patient-centered care is improved by providing multiple effective treatment options and this project, if successful, could have a significant impact on VA care. This CDA-2 project has the potential to offer innovative treatment for traumatized combat Veterans who otherwise may not find full relief from PTSD. Clinical research practice will be advanced by employing state-of-the-art user-centered design methods combined with expert clinical feedback to develop an effective and usable group treatment manual that will meet VA needs.

Detailed description: Approximately 25% of combat Veterans with Posttraumatic Stress Disorder (PTSD) seek treatment for traumas that involve potentially morally injurious events (PMIE) rather than danger-based traumas. PMIEs are more strongly associated with functional and psychiatric impairment than life-threat-based combat. Veterans report that PMIEs disrupt their sense of identity and meaning, ability to connect with and trust others, and engender disturbing guilt, shame, rage, and disgust. The sequelae of exposure to PMIEs, otherwise known as moral injury, may explain variance in post-deployment recovery and is a potential unaddressed treatment target. Existing first-line treatments may be limited because they were derived from civilian contexts, poorly fit the war zone context, and do not allow Veterans to discuss the details of the PMIEs with other Veterans. This project will develop a relational dynamic-based group therapy treatment manual that will target functioning and quality of life among Veterans who are impacted by high magnitude PMIEs. The goal of this relational dynamic trauma therapy is to help Veterans identify connections between their current symptoms and their experiences in combat/PMIEs, their current life stressors and relationships, and the historical factors that carry person-specific meaning to their trauma/PMIE. These explorations take place in the presence of attuned and sympathetic others who can resonate to the experience and the affect being expressed. Symptom reduction occurs through increasing the Veteran's capacity to consciously reflect on their experiences and develop an integrated self-awareness of the various factors that affect their mental states. The result is greater self-reflection, less avoidance, and greater adaptive incorporation of life experiences and their aftermath and meanings into one's inner world. This CDA-2 will employ innovative user-centered design methods that continuously gather user experiences during treatment development, with the goal of increased effectiveness and usability. User feedback will be synthesized with formative feedback from a clinical expert panel. This objective will be accomplished by pursuing these specific aims: Aim 1: Discover user needs and preferences as well as treatment-engagement barriers and facilitators from the perspectives of PMIE-impacted Veterans and VA trauma clinicians. Aim 2: Design a treatment manual and refine it using feedback from Veterans, trauma clinicians, and an expert clinical advisory board. Aim 3: Conduct two rapid prototyping open trials (i.e., tangibly testing treatment approaches using a prototype manual) with PMIE-impacted Veterans (N = \~12), and iteratively revise the manual based on Veteran, provider, and clinical expert panel feedback, with the following hypothesis: The treatment manual will meet usability, feasibility, learnability, and acceptability criteria.

Eligibility criteria: Inclusion Criteria:

* The investigators will recruit 12 potentially morally injurious event (PMIE)-impaired Veterans.
* Potential participants include:

  * male and female
  * English-speaking Veterans
  * 18 years of age or older
  * enrolled in Central Texas Veterans Healthcare System
  * with a service record of combat deployments
* Participants must:

  * comprehend and sign the informed consent form
  * if they report a PMIE as their worst trauma
  * 3 on the MIOS functional impairment item
  * if they score 10 on the SDS

Exclusion Criteria:

* Veterans will be excluded from the study if they have either:

  * untreated substance abuse disorder
  * severe suicidal or homicidal ideation, defined using the C-SSRS
  * \<18 on the MOCA, indicating potential for more than mild cognitive impairment

Primary outcomes:
measure: Change in Intervention Usability Scale (IUS)
timeFrame: After each weekly therapy session and following the conclusion of the intervention, up to 6 months
measure: Change in Acceptability of Intervention Measure (AIM)
timeFrame: After each weekly therapy session and following the conclusion of the intervention, up to 6 months
measure: Change in Implementation Appropriateness Measure (IAM)
timeFrame: After each weekly therapy session and following the conclusion of the intervention, up to 6 months
measure: Change in Feasibility of Intervention Measure (FIM)
timeFrame: After each weekly therapy session and following the conclusion of the intervention, up to 6 months
Secondary outcomes:
measure: Change in Sheehan Disability Scale (SDS)
timeFrame: Pre intervention (Baseline), post intervention (approximately 6 weeks), and following the conclusion of the intervention, up to 6 months
measure: Change in Moral Injury Outcome Scale (MIOS)
timeFrame: Pre intervention (Baseline), post intervention (approximately 6 weeks), and following the conclusion of the intervention, up to 6 months
measure: Change in Posttraumatic Stress Disorder Checklist-5 (PCL-5)
timeFrame: Pre intervention (Baseline), post intervention (approximately 6 weeks), and following the conclusion of the intervention, up to 6 months
measure: Change in Beck Depression Inventory-II (BDI-II)
timeFrame: Pre intervention (Baseline), post intervention (approximately 6 weeks), and following the conclusion of the intervention, up to 6 months
measure: Change in Beck Scale for Suicide Ideation (BSS)
timeFrame: Pre intervention (Baseline), post intervention (approximately 6 weeks), and following the conclusion of the intervention, up to 6 months
measure: Change in Religious and Spiritual Struggles Scale (RSSS)
timeFrame: Pre intervention (Baseline), post intervention (approximately 6 weeks), and following the conclusion of the intervention, up to 6 months
measure: Group Cohesion Scale-Revised (GCS)
timeFrame: Post intervention (approximately 6 weeks)
measure: Change in Moral Injury Events Scale (MIES)
timeFrame: Pre intervention (Baseline), post intervention (approximately 6 weeks), and following the conclusion of the intervention, up to 6 months
measure: Change in Brief Expressions of Moral Injury Scale (EMIS)
timeFrame: Pre intervention (Baseline), post intervention (approximately 6 weeks), and following the conclusion of the intervention, up to 6 months
Other outcomes:
measure: Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Eligibility screening (pre-intervention)
Locations:
city: Temple
country: United States
facility: Central Texas Veterans Health Care System, Temple, TX
state: Texas
Study officials:
affiliation: Central Texas Veterans Health Care System, Temple, TX
name: Sheila Frankfurt, PhD
role: PRINCIPAL_INVESTIGATOR
References: