Innovative Therapies for Moral Injury

Recruiting at 5 trial locations

Overseen By Jeanette I Harris, PhD MS MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Active psychosis, Substance use, Severe psychopathology, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

200 Participants Needed

Trial Summary

What is the purpose of this trial?

Moral Injury Syndrome (MIS) affects up to 35-60% of Veterans managing combat-related PTSD; it results from experiences that challenge deeply held values or spiritual beliefs. Symptoms of MIS may include hopelessness, helplessness, loss of spiritual beliefs, difficulty with forgiveness, loss of meaning or purpose, reduced trust in self or others, or intractable guilt, shame or anger. Veterans managing MIS have difficulty responding to mental health treatment, and are at increased risk for suicide ideation or attempts. To date evidence-based interventions for MIS are not widely available in VA. This study will implement an evidence-based intervention for MIS in four VA facilities, collect data on the effectiveness of the intervention, and develop an implementation toolkit. This data will inform national dissemination in collaboration with the Office of Mental Health and Suicide Prevention and the National Chaplain Service.

Will I have to stop taking my current medications?

The trial requires that participants have been stable on their mental health medications for at least 8 weeks, so you will not need to stop taking your current medications if they have been stable for that period.

What data supports the effectiveness of the treatment Building Spiritual Strength for moral injury?

Research shows that spiritually integrated therapies, like Building Spiritual Strength, can help reduce symptoms of moral injury and PTSD by incorporating spiritual beliefs into treatment. Similar treatments have shown significant improvements in veterans' symptoms, suggesting that addressing spiritual and moral aspects can be beneficial. ^{1 2 3 4 5}

Is the treatment for moral injury safe for humans?

The treatment, Building Spiritual Strength, has been used safely in studies with military veterans and older trauma survivors, showing reductions in symptoms like PTSD and depression without reported safety concerns. ^{3 4 5 6 7}

How is the treatment Building Spiritual Strength, Present Centered Group Therapy unique for moral injury?

Building Spiritual Strength, Present Centered Group Therapy is unique because it focuses on addressing moral injury by integrating spiritual and present-focused approaches, which is different from traditional therapies that may not specifically target the spiritual or moral dimensions of trauma. ^{8 9 10 11 12}

Research Team

Jeanette Irene Harris, PhD MS MS

Principal Investigator

Maine VA Medical Center, Augusta, ME

Eligibility Criteria

This trial is for Veterans who are struggling with Moral Injury Syndrome (MIS) as a result of combat-related PTSD. It's aimed at those who have symptoms like hopelessness, loss of spiritual beliefs, and persistent guilt or anger. Participants should be seeking treatment within the VA system.

Inclusion Criteria

Veteran status and validation of any of the first three items on the Moral Injury and Distress Scale, which is consistent with probable MIS

I am 18 years old or older.

I am willing to be assigned to any treatment group by chance.

Exclusion Criteria

I am unable to understand and make decisions about my health care.

Active psychosis or substance use at levels that would interfere with treatment, assessed via chart review, the Alcohol Use Disorders Identification Test - Concise (AUDIT-C) score, and the Mini International Neuropsychiatric Interview (MINI)

I am currently receiving therapy for my mental health condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-implementation Evaluation

Conduct a mixed methods pre-implementation evaluation to identify barriers and facilitators for BSS implementation at each site

4 weeks

Treatment

Participants receive either Building Spiritual Strength (BSS) or Present Centered Group Therapy (PCGT) for 8 weeks

8 weeks

Post-implementation Evaluation

Conduct a mixed methods post-implementation evaluation to compare outcomes across chaplaincy managed vs. mental health managed BSS programs

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

• Building Spiritual Strength
• Present Centered Group Therapy

Trial Overview The study tests two interventions: Present Centered Group Therapy and Building Spiritual Strength to treat MIS in veterans. The effectiveness will be measured across four VA facilities to potentially inform national strategies for managing MIS.

Participant Groups

Group I: Building Spiritual Strength Experimental Treatment 1 Intervention

Spiritually integrated group intervention for moral injury.

Group II: Present Centered Group Therapy Active Control 1 Intervention

Coping strategies group intervention addressing broad spectrum trauma symptoms

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Michael E. DeBakey VA Medical Center

Collaborator

Trials

68

Recruited

17,200+

VA Central Alabama Health Care System

Collaborator

Trials

1

Recruited

200+

VA Atlanta Healthcare System

Collaborator

Trials

1

Recruited

200+

Minneapolis Veterans Affairs Medical Center

Collaborator

Trials

77

Recruited

355,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Treatment of Moral Injury in U.S. Veterans with PTSD Using a Structured Chaplain Intervention. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Acceptance and forgiveness therapy for veterans with moral injury: spiritual and psychological collaboration in group treatment. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Spiritually Integrated Cognitive Processing Therapy for Moral Injury in the Setting of PTSD: Initial Evidence of Therapeutic Efficacy. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Building Spiritual Strength: a Spiritually Integrated Approach to Treating Moral Injury. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Rationale for Spiritually Oriented Cognitive Processing Therapy for Moral Injury in Active Duty Military and Veterans With Posttraumatic Stress Disorder. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

The effectiveness of a trauma focused spiritually integrated intervention for veterans exposed to trauma. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a spiritually focused intervention with older trauma survivors. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Effects of EDTA gel preconditioning of periodontally affected human root surfaces on chlorhexidine substantivity - an SEM study. [2013]

9. Germany pubmed.ncbi.nlm.nih.gov

Clinical and microbiological effects of a single application of sodium hypochlorite gel during subgingival re-instrumentation: a triple-blind randomized placebo-controlled clinical trial. [2023]

10. Korea (South) pubmed.ncbi.nlm.nih.gov

Localized probiotic-guided pocket recolonization in the treatment of chronic periodontitis: a randomized controlled clinical trial. [2021]

11. India pubmed.ncbi.nlm.nih.gov

Effects of tetracycline-containing gel and a mixture of tetracycline and citric acid-containing gel on non-surgical periodontal therapy. [2013]

12. United States pubmed.ncbi.nlm.nih.gov

Clinical and microbiological effects of Lactobacillus reuteri probiotics in the treatment of chronic periodontitis: a randomized placebo-controlled study. [2022]