Innovative Therapies for Moral Injury

Enrolling by invitation 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist veterans dealing with Moral Injury Syndrome (MIS), a condition that can lead to feelings of hopelessness, guilt, and anger after experiences that challenge their values. It will test two group therapies: Building Spiritual Strength, which integrates spiritual support, and Present Centered Group Therapy, which focuses on general coping strategies. The goal is to determine the effectiveness of these therapies in managing MIS. Veterans who may be suitable participants have maintained stable mental health on medications for at least 8 weeks and are willing to try either therapy offered. As an unphased trial, this study provides veterans the opportunity to explore new therapeutic approaches tailored to their unique experiences.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found "Building Spiritual Strength" (BSS) to be safe and helpful for people dealing with moral injury. Participants generally handled the therapy well, with few serious side effects. The focus on spirituality resonated with many, offering a unique way to heal.

Research has shown that "Present Centered Group Therapy" (PCGT) is also likely safe. It helps people deal with trauma by focusing on current challenges. This therapy is commonly used for PTSD (post-traumatic stress disorder), suggesting it is usually well-tolerated.

Both BSS and PCGT have been part of studies showing they are safe options for those seeking help with moral injury. While any treatment can have risks, these therapies have been tested and generally found safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the treatments for moral injury because they offer innovative approaches compared to traditional therapies. Building Spiritual Strength is unique as it integrates spiritual elements into therapy, providing a holistic approach that addresses the moral and existential dimensions of trauma, which are often overlooked by conventional methods. Present Centered Group Therapy focuses on developing coping strategies for a wide range of trauma symptoms, offering a more adaptable and comprehensive approach than many existing treatments that often target specific symptoms. These therapies aim to provide more personalized and meaningful support for individuals dealing with moral injury, a condition that traditional treatments might not fully address.

What evidence suggests that this trial's treatments could be effective for Moral Injury Syndrome?

Research has shown that "Building Spiritual Strength" (BSS), a treatment in this trial, offers a promising approach to addressing moral injury. In two studies, BSS reduced PTSD symptoms in military members. The program incorporates spiritual elements and focuses on resolving moral and spiritual distress, common in moral injury. Although BSS did not outperform "Present Centered Group Therapy," another treatment option in this trial focused on personal growth, it still provided significant benefits. The treatment addresses the spiritual and moral issues causing distress, offering a unique path to healing. ^{1 3 4 6 7}

Who Is on the Research Team?

Jeanette Irene Harris, PhD MS MS

Principal Investigator

Maine VA Medical Center, Augusta, ME

Are You a Good Fit for This Trial?

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 willing to be assigned to any treatment group by chance.

I have been on the same mental health medications for at least 8 weeks.

Exclusion Criteria

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)

Managing any severe psychopathology that, in the opinion of the investigative team, requires immediate clinical attention, such as imminent suicide risk, assessed via the MINI and supplemental homicide risk questions

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. marketplace.va.gov marketplace.va.gov/innovations/building-spiritual-strength

Building Spiritual Strength (BSS) - Diffusion Marketplace BSS groups are an ethically appropriate, spiritually integrated model for resolving moral injury/spiritual distress. Two randomized controlled ...

2. psycnet.apa.org psycnet.apa.org/record/2020-56133-013

Building spiritual strength: A group treatment for posttraumatic ... Building spiritual strength: A group treatment for posttraumatic stress disorder, moral injury, and spiritual distress. Publication Date. 2021. Language.

3. chaplaincyinnovation.org chaplaincyinnovation.org/wp-content/uploads/2020/09/BSS-in-Psychiatry-Research.pdf

A randomized controlled trial of “Building Spiritual Strength” This study tests the efficacy of a spiritually integrated in- tervention “Building Spiritual Strength” (BSS) that can be delivered by trained ...

4. clinicaltrial.be clinicaltrial.be/en/details/423420?only_active=0&only_eligible=0&only_recruiting=0&per_page=100

Implementation of Innovative Treatment for Moral Injury S... Individuals managing MIS are up to twice as likely as their peers to consider and attempt suicide, and derive less benefit from psychotherapy.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36466719/

a Spiritually Integrated Approach to Treating Moral Injury Recent findings: Two RCTs have demonstrated BSS led to a decrease in PTSD symptoms in military members. Though BSS did not outperform a person-centered group ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9685023/

a Spiritually Integrated Approach to Treating Moral Injury This article reviews a spiritually integrated group therapy, Building Spiritual Strength (BSS), designed to treat moral injury and associated syndromes.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165178117322515

A randomized controlled trial of “Building Spiritual Strength” This study tests the efficacy of a spiritually integrated intervention “Building Spiritual Strength” (BSS) that can be delivered by trained chaplains.