Moral Injury SyndromeNCT06230887
Implementation of Innovative Treatment for Moral Injury Syndrome: A Hybrid Type 2 Study
A study testing Building Spiritual Strength and Present Centered Group Therapy in people with Moral Injury Syndrome, run by VA Office of Research and Development at 5 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moral Injury Syndrome
- What is being tested?
- Building Spiritual Strength and Present Centered Group Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 5 sitesUnited States
- Study dates
- 30 Jul 2024to 31 Jul 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veteran status and:
- (a) validation of any of the first three items on the Moral Injury and Distress Scale, which is consistent with probable MIS
- (b) willingness to be randomized to either treatment condition
- (c) stability on mental health medications for at least 8 weeks
- (d) age of 18 years or older
Who cannot join
- (a) insufficient capacity to consent
- (b) 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)
- (c) currently involved in evidence-based psychotherapy for MIS, or evidence-based psychotherapy for PTSD, assessed via chart review and intake interview
- (d) 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites
Maine VA Medical Center, Augusta, ME
Augusta, Maine, 04330
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, 30033-4004
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030-4211
Central Arkansas Veterans Healthcare System , Little Rock, AR
Little Rock, Arkansas, 72205
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417-2309
About this study
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.
Read the detailed description
Background: Moral injury syndrome (MIS) consists of the psychological and behavioral sequelae of experiences that challenge moral, spiritual, or values related beliefs. Symptoms of MIS may include hopelessness, helplessness, loss of previously held spiritual beliefs, struggle with a Higher Power, difficulty with forgiveness, lack of meaning or purpose, reduced trust in self or others, or intractable guilt, shame or anger. Individuals managing MIS are up to twice as likely as their peers to consider and attempt suicide, and derive less benefit from psychotherapy. There are few evidence-based interventions for moral injury; one such intervention is a manualized, group intervention called "Building Spiritual Strength (BSS)." In previous randomized controlled trials BSS has been shown to reduce both symptoms of PTSD and spiritual distress.
This clinical trial will be one of the first to measure symptoms of MIS as a primary outcome. Hypotheses are:
- Compared to Present Centered Group Therapy (PCGT), BSS will significantly decrease symptoms of MIS.
- Compared to PCGT, BSS will significantly decrease symptoms of PTSD, depression, and suicidal ideation.
Significance: To date there are not standard procedures for assessing and treating MIS, so it is likely that untreated MIS is contributing to poor outcomes, including suicides. Developing an implementation toolkit so that BSS is widely available in VA facilities could reduce the impact of MIS on Veterans' mental health.
Innovation and Impact: To date there have not been funded implementation studies on treatments for MIS in Veterans, and very few VA facilities provide evidence-based care for MIS. This study can clear the way to make evidence-based care for MIS more accessible in the VA system.
Specific Aims:
- Conduct a mixed methods pre-implementation evaluation to identify barriers and facilitators for BSS implementation at each site, and to develop local implementation strategies. Specific implementation variables assessed, based on the Proctor and EBQI models include acceptability, appropriateness, and feasibility. Specific variables to be assessed will include a) acceptability of BSS to stakeholders, b) available implementation resources, and c) organizational openness to adding a new EBP.
- Conduct a randomized controlled trial comparing BSS to Present Centered Group Therapy (PCGT) for Veterans who score above cutoff on the Moral Injury Outcomes Scale. Effectiveness and functional outcomes will be informed by the psychospiritual developmental model of MIS.
- Conduct a mixed methods post-implementation evaluation to compare outcomes across chaplaincy managed vs. mental health managed BSS programs. Proctor model outcomes will include adoption, fidelity, penetration, and sustainability. Specific outcomes related to this framework include a) successful BSS implementation, b) fidelity in implementation of BSS, c) percentage of eligible, referred Veterans who access BSS services, and d) qualitative reports of intent to maintain the BSS program when the study is complete.
Methodology: This will be a type 2 hybrid study, combining pre- and post-implementation evaluations with a randomized clinical trial at 4 culturally diverse VA sites.
Next Steps and Implementation: Data on barriers and facilitators will be used to develop a toolkit and collaborate with study partners at the Office of Mental Health and Suicide Prevention and the National Chaplain Service to develop a national dissemination plan for BSS. The investigators will work with existing clinical staffing at the study sites, so that those sites can continue to provide BSS services after the study. Furthermore, after completing this study, BSS leaders will be qualified to train BSS leaders at other sites, creating resources for training and national dissemination.
- Conditions
- Moral Injury Syndrome
- Being tested
- Building Spiritual Strength, Present Centered Group Therapy
- Keywords
- Moral Injury, Posttraumatic Stress Disorder, Spirituality, chaplains
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Building Spiritual StrengthBehavioural
Spiritually Integrated group intervention for moral injury
Present Centered Group TherapyBehavioural
Active control, manualized evidence-based coping skills intervention for PTSD
| Study group | Role | What they receive |
|---|---|---|
| Building Spiritual Strength | Experimental | Spiritually integrated group intervention for moral injury. Receives: Behavioral: Building Spiritual Strength |
| Present Centered Group Therapy | Active comparator | Coping strategies group intervention addressing broad spectrum trauma symptoms Receives: Behavioral: Present Centered Group Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Moral Injury and Distress Scale
Full Scale Name: Moral Injury and Distress Scale Score Range: 0-90, with higher scores indicating more symptoms.
Measured: 8 weeks (end of treatment) and 20 weeks (long-term follow-up)
Change in Moral Injury Outcomes Scale
Full Scale Name: Moral Injury and Distress Scale Score Range: 0-56, with higher scores indicating more symptoms.
Measured: 8 weeks (end of treatment) and 20 weeks (long-term follow-up)
Change in Religious and Spiritual Struggles Scale
Full Scale Name: Religions and Spiritual Struggles Scale Score Range: 0=4 with higher scores indicating more symptoms
Measured: 8 weeks (end of treatment) and 20 weeks (long-term follow-up)
Secondary outcomes (8)
Change in Patient Health Questionnaire-9
Full Scale Name: Patient Health Questionnaire-9 Score range: 1-27, with higher scores indicating more symptoms
Measured: 8 weeks (end of treatment) and 20 weeks (long-term follow-up)
Change in Sheehan Disability Scale
Full Scale Name: Sheehan Disability Scale Score Range: 0-30, with higher scores indicating more functional disability
Measured: 8 weeks (end of treatment) and 20 weeks (long-term follow-up)
Change in Beck Scale for Suicide Ideation
Full Scale Name: Beck Scale for Suicide Ideation Score Range: 0-38, with higher values indicating a greater risk of suicide
Measured: 8 weeks (end of treatment) and 20 weeks (long-term follow-up)
Change in Reasons for Living Inventory
Full Scale Name: Reasons for Living Inventory Score Range: 48-288, with higher scores represent more reasons to live.
Measured: 8 weeks (end of treatment) and 20 weeks (long-term follow-up)
PTSD Checklist for DSM-5
Full Scale Name: PTSD Checklist for DSM-5 Score Range 0-80, with higher numbers indicating greater symptom severity
Measured: 8 weeks (end of treatment) and 20 weeks (long-term follow-up)
Client Satisfaction Questionnaire-8
Full Scale Name: Client Satisfaction Questionnaire-8 Score Range 8-32, with higher numbers indicating greater satisfaction.
Measured: 8 weeks (end of treatment)
Psychospiritual Development Scale
Full Scale Name: Multiscale Measure for Postconventional Spiritual Functioning Score Range measures different reasoning levels and is structured around four distinct subscales rather than a single total score: conventional vs. postconventional levels of religious reasoning, with decisions to be an adherent or a disaffiliate of faith
Measured: 8 weeks (end of treatment) and 20 weeks (long-term follow-up)
Spiritual Fortitude Questionnaire
Full Scale Name: Spiritual Fortitude Questionnaire Score Range 9-45, with higher numbers indicating greater spiritual fortitude
Measured: 8 weeks (end of treatment) and 20 weeks (long-term follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start30 Jul 2024
- Primary completion1 Jan 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moral Injury SyndromeStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to either the experimental condition (Building Spiritual Strength, an evidence-based, manualized, spiritually integrated group counseling program for moral injury/spiritual distress/values related distress associated with trauma) or the control condition (Present Centered Group Therapy, an evidence-based, manualized group treatment for PTSD.)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- VA Central Arkansas Health Care System, VA Atlanta Healthcare System, Michael E. DeBakey VA Medical Center, Minneapolis Veterans Affairs Medical Center, VA Maine Healthcare System
- Responsible party
- Sponsor
- Investigators
- Jeffrey M Pyne, MD, Principal investigator, Central Arkansas Veterans Healthcare System , Little Rock, AR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230887
- Sponsor's protocol ID
- IIR 22-132
- Status last verified
- Jul 2026
- First submitted
- 19 Jan 2024
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sites involved in this study may share IPD via a) secure, VA approved videoconferencing, b) telephone, c) secure, VA approved electronic data sharing, and d) encrypted e-mail.