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Consulting After Combat: Interviewing Veterans to Develop a Therapy to Restore Functioning and Reintegration After Moral Injury Events (CAC)

Primary Purpose

Moral Injury, Functional Impairment

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Open pilot trial of a group therapy manual.
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moral Injury focused on measuring Moral Injury, Group Psychotherapy, Veterans

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Central Texas Veterans Health Care System, Temple, TXRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Open Pilot Trial

Arm Description

Open pilot trial of a group therapy manual.

Outcomes

Primary Outcome Measures

Change in Intervention Usability Scale (IUS)
The 10-item IUS was adapted from the widely used System Usability Scale. It is scored on a Likert-style scale ranging from 0 (strongly disagree) to 4 (strongly agree). The IUS generates a percentile ranking, and scores >68 are considered above average.
Change in Acceptability of Intervention Measure (AIM)
The AIM will be descriptively analyzed, and the mean and standard deviation for each session and for the final session will be reported; mean scores 4 will indicate acceptability.
Change in Implementation Appropriateness Measure (IAM)
The IAM is a 4-item measure. The IAM will be descriptively analyzed, and the mean and standard deviation for each session and for the final session will be reported; mean scores 4 will indicate appropriateness (via the IAM).
Change in Feasibility of Intervention Measure (FIM)
The FIM is a 4-item measure. The FIM will be descriptively analyzed, and the mean and standard deviation for each session and for the final session will be reported; mean scores > 4 will indicate feasibility (via the FIM).

Secondary Outcome Measures

Change in Sheehan Disability Scale (SDS)
The SDS is a 5-item measure that assess social and occupational functional impairment. Respondents rate the extent to which work/school, social life and home life or family responsibilities are impaired by his or her symptoms on a 10 point visual analog scale. Scores range from 0 (unimpaired) to 30 (highly impaired). Change in disability from pre- to post-intervention will be examined.
Change in Moral Injury Outcome Scale (MIOS)
The 15-item MIOS assesses exposure to a PMIE, prior month multidimensional outcomes associated with the PMIE, and prior month PMIE-related functional impairment. Items are rated on a Likert-style scale ranging from 0 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of more moral injury. Change in moral injury from pre- to post-intervention will be examined.
Change in Posttraumatic Stress Disorder Checklist-5 (PCL-5)
PTSD will be measured with the widely used 20-item Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5), which assesses severity of each DSM-5 PTSD symptom using a Likert-style ranging from 0 (not at all) to 4 (extremely). A total score of 31-33 is suggestive of a PTSD diagnosis. Change in PTSD symptom severity from pre- to post-intervention will be examined.
Change in Beck Depression Inventory-II (BDI-II)
Depression will be measured with the 21-item Beck Depression Inventory-II (BDI-II), which uses a Likert-style scale ranging from 0 to 3. Lower scores are indicative of less severe depression. Change in depressive symptoms from pre- to post-intervention will be examined.
Change in Beck Scale for Suicide Ideation (BSS)
Suicidal ideation will be measured using the Beck Scale for Suicide Ideation (BSS), which is extensively used in treatment studies of suicidal individuals. The BSS is rated on a Likert-style scale ranging from 0 to 3, which lower scores indicative of less severe suicidal ideation. Change in suicidal ideation from pre- to post-intervention will be examined.
Change in Religious and Spiritual Struggles Scale (RSSS)
The 26-item RSSS assesses six domains including moral and doubt struggles using a Likert-style scale ranging from 0 to 5.
Change in Group Cohesion Scale-Revised (GCS)
The 25-item Group Cohesion Scale-Revised measures group functioning on a Likert-style ranging from 0 (low) to 4 (strongly agree). Higher scores are indicative of greater group cohesion.
Change in Moral Injury Events Scale (MIES)
The MIES is a 9-item measure that assess perceptions of potentially morally injurious events. Items are rated on a 1 (Strongly agree) to 6 (strongly disagree) Likert-style scale, and lower scores are indicative of more moral injury. Change in endorsement of moral injury events will be assessed from pre- to post-intervention.
Change in Expressions of Moral Injury Scale (EMIS)
The EMIS is a 17-item scale that assesses moral injury event-related guilt, shame, and related outcomes. Items are rated on a Likert-style on a 5-point scale (1 = strongly disagree to 5 = strongly agree). Higher scores indicate greater moral injury. Change in moral injury will be assessed from pre- to post-intervention.

Full Information

First Posted
July 12, 2021
Last Updated
January 19, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05020587
Brief Title
Consulting After Combat: Interviewing Veterans to Develop a Therapy to Restore Functioning and Reintegration After Moral Injury Events
Acronym
CAC
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
October 31, 2025 (Anticipated)
Study Completion Date
October 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moral Injury, Functional Impairment
Keywords
Moral Injury, Group Psychotherapy, Veterans

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Open Pilot Trial
Arm Type
Other
Arm Description
Open pilot trial of a group therapy manual.
Intervention Type
Behavioral
Intervention Name(s)
Open pilot trial of a group therapy manual.
Intervention Description
Open pilot trial of a group therapy manual.
Primary Outcome Measure Information:
Title
Change in Intervention Usability Scale (IUS)
Description
The 10-item IUS was adapted from the widely used System Usability Scale. It is scored on a Likert-style scale ranging from 0 (strongly disagree) to 4 (strongly agree). The IUS generates a percentile ranking, and scores >68 are considered above average.
Time Frame
After each weekly therapy session and following the conclusion of the intervention, up to 6 months
Title
Change in Acceptability of Intervention Measure (AIM)
Description
The AIM will be descriptively analyzed, and the mean and standard deviation for each session and for the final session will be reported; mean scores 4 will indicate acceptability.
Time Frame
After each weekly therapy session and following the conclusion of the intervention, up to 6 months
Title
Change in Implementation Appropriateness Measure (IAM)
Description
The IAM is a 4-item measure. The IAM will be descriptively analyzed, and the mean and standard deviation for each session and for the final session will be reported; mean scores 4 will indicate appropriateness (via the IAM).
Time Frame
After each weekly therapy session and following the conclusion of the intervention, up to 6 months
Title
Change in Feasibility of Intervention Measure (FIM)
Description
The FIM is a 4-item measure. The FIM will be descriptively analyzed, and the mean and standard deviation for each session and for the final session will be reported; mean scores > 4 will indicate feasibility (via the FIM).
Time Frame
After each weekly therapy session and following the conclusion of the intervention, up to 6 months
Secondary Outcome Measure Information:
Title
Change in Sheehan Disability Scale (SDS)
Description
The SDS is a 5-item measure that assess social and occupational functional impairment. Respondents rate the extent to which work/school, social life and home life or family responsibilities are impaired by his or her symptoms on a 10 point visual analog scale. Scores range from 0 (unimpaired) to 30 (highly impaired). Change in disability from pre- to post-intervention will be examined.
Time Frame
Pre intervention (Baseline), post intervention (approximately 6 weeks), and following the conclusion of the intervention, up to 6 months
Title
Change in Moral Injury Outcome Scale (MIOS)
Description
The 15-item MIOS assesses exposure to a PMIE, prior month multidimensional outcomes associated with the PMIE, and prior month PMIE-related functional impairment. Items are rated on a Likert-style scale ranging from 0 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of more moral injury. Change in moral injury from pre- to post-intervention will be examined.
Time Frame
Pre intervention (Baseline), post intervention (approximately 6 weeks), and following the conclusion of the intervention, up to 6 months
Title
Change in Posttraumatic Stress Disorder Checklist-5 (PCL-5)
Description
PTSD will be measured with the widely used 20-item Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5), which assesses severity of each DSM-5 PTSD symptom using a Likert-style ranging from 0 (not at all) to 4 (extremely). A total score of 31-33 is suggestive of a PTSD diagnosis. Change in PTSD symptom severity from pre- to post-intervention will be examined.
Time Frame
Pre intervention (Baseline), post intervention (approximately 6 weeks), and following the conclusion of the intervention, up to 6 months
Title
Change in Beck Depression Inventory-II (BDI-II)
Description
Depression will be measured with the 21-item Beck Depression Inventory-II (BDI-II), which uses a Likert-style scale ranging from 0 to 3. Lower scores are indicative of less severe depression. Change in depressive symptoms from pre- to post-intervention will be examined.
Time Frame
Pre intervention (Baseline), post intervention (approximately 6 weeks), and following the conclusion of the intervention, up to 6 months
Title
Change in Beck Scale for Suicide Ideation (BSS)
Description
Suicidal ideation will be measured using the Beck Scale for Suicide Ideation (BSS), which is extensively used in treatment studies of suicidal individuals. The BSS is rated on a Likert-style scale ranging from 0 to 3, which lower scores indicative of less severe suicidal ideation. Change in suicidal ideation from pre- to post-intervention will be examined.
Time Frame
Pre intervention (Baseline), post intervention (approximately 6 weeks), and following the conclusion of the intervention, up to 6 months
Title
Change in Religious and Spiritual Struggles Scale (RSSS)
Description
The 26-item RSSS assesses six domains including moral and doubt struggles using a Likert-style scale ranging from 0 to 5.
Time Frame
Pre intervention (Baseline), post intervention (approximately 6 weeks), and following the conclusion of the intervention, up to 6 months
Title
Change in Group Cohesion Scale-Revised (GCS)
Description
The 25-item Group Cohesion Scale-Revised measures group functioning on a Likert-style ranging from 0 (low) to 4 (strongly agree). Higher scores are indicative of greater group cohesion.
Time Frame
Post intervention (approximately 6 weeks)
Title
Change in Moral Injury Events Scale (MIES)
Description
The MIES is a 9-item measure that assess perceptions of potentially morally injurious events. Items are rated on a 1 (Strongly agree) to 6 (strongly disagree) Likert-style scale, and lower scores are indicative of more moral injury. Change in endorsement of moral injury events will be assessed from pre- to post-intervention.
Time Frame
Pre intervention (Baseline), post intervention (approximately 6 weeks), and following the conclusion of the intervention, up to 6 months
Title
Change in Expressions of Moral Injury Scale (EMIS)
Description
The EMIS is a 17-item scale that assesses moral injury event-related guilt, shame, and related outcomes. Items are rated on a Likert-style on a 5-point scale (1 = strongly disagree to 5 = strongly agree). Higher scores indicate greater moral injury. Change in moral injury will be assessed from pre- to post-intervention.
Time Frame
Pre intervention (Baseline), post intervention (approximately 6 weeks), and following the conclusion of the intervention, up to 6 months
Other Pre-specified Outcome Measures:
Title
Columbia Suicide Severity Rating Scale (C-SSRS)
Description
The C-SSRS is the VA-mandated suicide screening tool used in primary care and mental health clinics across the VA. The C-SSRS assesses lifetime and past-month suicidal ideation, intent, plans, and behavior.
Time Frame
Eligibility screening (pre-intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sheila Frankfurt, PhD
Phone
(254) 400-6742
Email
Sheila.Frankfurt@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheila Frankfurt, PhD
Organizational Affiliation
Central Texas Veterans Health Care System, Temple, TX
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Texas Veterans Health Care System, Temple, TX
City
Temple
State/Province
Texas
ZIP/Postal Code
76504-7451
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katerine Getchell, PharmD
Phone
254-743-0438
Email
Katerine.Getchell@va.gov
First Name & Middle Initial & Last Name & Degree
Sheila Frankfurt, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Participants will have the option of agreeing to allow their data to be transferred into a secure, deidentified data repository. Individual participant data from those consenting participants will be transferred into a secure, deidentified data repository. Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose may have access. However, data will not be shared directly from this project.

Learn more about this trial

Consulting After Combat: Interviewing Veterans to Develop a Therapy to Restore Functioning and Reintegration After Moral Injury Events

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