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| ID | Type | Description | Link |
|---|---|---|---|
| PPO 22-211 | Other Grant/Funding Number | Veterans Affairs Health Services Research and Development |
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| Name | Class |
|---|---|
| VA Pittsburgh Healthcare System | FED |
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The goal of this clinical trial is to learn if the intervention can be delivered by VA chaplains and if it is acceptable for veterans who have symptoms of moral injury (guilt, shame, isolation) and are receiving VA mental health treatment. The main questions it aims to answer are:
Can the study team enroll veterans for this intervention and complete data collection? Will veterans complete the intervention?
There is no comparison group.
Participants will will complete a baseline and 6-month interview and participate in up to 12 intervention sessions with a VA chaplain. The intervention will focus on facilitating forgiveness and community connection.
Moral injury symptoms include guilt, shame, and self-isolation. Moral injury is also associated with increased suicide risk. Moral injury symptoms are common in Veterans being treated for posttraumatic stress disorder (PTSD) or substance use disorder (SUD) and current treatments do not always improve these symptoms. The Mental Health Clinician / Chaplain Collaboration (MC3) intervention is delivered by VA chaplains who facilitate forgiveness and community reintegration. MC3 is a collaboration between resources in the mental health clinic, chaplain service, and community to support moral injury symptom recovery.
Specific Aims:
Methodology: The study design is a two site one arm trial. The population is Veterans being treated in specialty mental health or substance use disorder clinics who have symptoms of moral injury. MC3 will be delivered by VA chaplains who will facilitate forgiveness and community reintegration. The primary outcomes are feasibility and acceptability. Quantitative and qualitative data will be collected at baseline and 6-months (end of intervention). Evidence-based quality improvement methods will be used to implement MC3 at the Little Rock and Pittsburgh VA Medical Centers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention focused on facilitating forgiveness and community connection | Experimental | Intervention is delivered by VA chaplains to facilitate forgiveness and community connection in collaboration with mental health clinicians |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| facilitate forgiveness and community connection to address symptoms of moral injury | Behavioral | VA chaplain delivered intervention to facilitate forgiveness and community connection in collaboration with mental health clinicians |
| Measure | Description | Time Frame |
|---|---|---|
| Number referred, enrolled, baseline and 6-month | referral, enrollment, and baseline and 6-month data collection | 6 months |
| intervention retention | number of sessions completed | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| moral injury distress | Moral Injury Distress Scale: 18 items, minimum score is 0, maximum score is 72, higher score means greater moral distress severity | baseline and 6 months |
| Religious and spiritual struggles |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeff M Pyne, MD | Contact | 501-442-6019 | jeffrey.pyne@va.gov |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Arkansas Veterans Healthcare System | Completed | Little Rock | Arkansas | 72114 | United States | |
De-identified data and limited data set data will be shared in consultation with the local research privacy officer and follow strict privacy protocols and approvals, e.g., upon written request and a signed data use agreement from a non-VA investigator. These requests could be to confirm conclusions made in publications, to duplicate statistical analyses or perform additional analysis.
one year after data collection is complete until protocol is closed
De-identified data and limited data set data will be shared in consultation with the local research privacy officer and follow strict privacy protocols and approvals, e.g., upon written request and a signed data use agreement from a non-VA investigator. These requests could be to confirm conclusions made in publications, to duplicate statistical analyses or perform additional analysis.
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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single arm study
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Religious and Spiritual Struggles Scale: 5-item Divine subscale, minimum score is 5, maximum score is 25, higher score means greater struggle with relationship with Divine and 4-item Ultimate Meaning subscale, minimum score is 0, maximum score is 20, higher score means greater struggle with meaning/purpose of life
| baseline and 6 months |
| Forgiving others | Decision to Forgive Scale: 6 items, minimum score is 6, maximum score is 30, higher score means stronger decision to forgive | baseline and 6-months |
| Self forgiveness | Self Forgiveness Dual Process Scale: 10 items, minimum score is 10, maximum score is 50, higher score means greater self-forgiveness | baseline and 6-months |
| PTSD symptom severity | Post Traumatic Stress Disorder Checklist for DSM-5: 20 items, minimum score is 0, maximum score is 80, higher score means greater post-traumatic stress disorder symptom severity | baseline and 6-months |
| Depression symptom serverity | Patient Health Questionnaire - 9: 9 items, minimum score is 0, maximum score is 27, higher score means greater depression symptom severity | baseline and 6-months |
| Functioning | Brief Inventory of Psychosocial Functioning: 7 items, one item for each domain and domains include romantic relationships, family relationships, work, friendships and socializing, parenting, education, and self-care. minimum score is 0, maximum score is 6 for each domain, higher score means more trouble in each domain | baseline and 6-months |
| Post-traumatic growth | Post-traumatic Growth Inventory: 15 items, 5 domains include appreciation of life, personal strength, new possibilities, relating to others, spiritual and existential change, minimum score is 0, maximum score is 75, higher score means more post-traumatic growth | baseline and 6-months |
| Social satisfaction | Social Satisfaction: 3 items, minimum score is 1, maximum score is 5, higher score means more satisfaction | baseline and 6-months |
| Loneliness | UCLA Loneliness Scale: 20 items, minimum score is 1, maximum score is 60, higher score means more loneliness | baseline and 6-months |
| VA Pittsburgh Healthcare System |
| Recruiting |
| Pittsburgh |
| Pennsylvania |
| 15240 |
| United States |
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