Ignite Creation Date:
2024-05-06 @ 4:34 PM
Last Modification Date:
2024-10-26 @ 2:12 PM
Study NCT ID:
NCT05020587
Status:
RECRUITING
Last Update Posted:
2024-01-05
First Post:
2021-07-12
Brief Title:
Consulting After Combat Interviewing Veterans to Develop a Therapy to Restore Functioning and Reintegration After Moral Injury Events
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Consulting After Combat Interviewing Service Members and Veterans to Develop a Therapy to Restore Functioning and Reintegration After Moral Injury Events
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAC
Brief Summary:
Despite the VAs 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 combatPMIEs their current life stressors and relationships and the historical factors that carry person-specific meaning to their traumaPMIE 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 Veterans 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 ones 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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RX003495 | REGISTRY | eRA Commons | None |