A Novel Posttraumatic Stress Disorder Treatment for Veterans With Moral Injury

NCT03764033 | Completed Results

• 2 other identifiers: D2946-RI01RX004243
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

The objective of this project is to test the efficacy of an individual treatment for post-traumatic stress disorder (PTSD) stemming from moral injury called Impact of Killing (IOK), compared to a present-centered therapy (PCT) control condition, and to determine the rehabilitative utility of IOK for Veterans with PTSD. The first aim is to test whether IOK can help improve psychosocial functioning for Veterans, as well as PTSD symptoms. The second aim is to determine whether IOK gains made by Veterans in treatment are durable, as measured by a six-month follow-up assessment. Veterans who kill in war are at increased risk for functional difficulties, PTSD, alcohol abuse, and suicide. Even after current PTSD psychotherapies, most Veterans continue to meet diagnostic criteria for PTSD, highlighting the need for expanding treatments for PTSD and functioning. IOK is a treatment that can be provided following existing PTSD treatments, filling a critical gap for Veterans with moral injury who continue to suffer from mental health symptoms and functional difficulties.

Conditions

Moral Injury

Keywords

Stress Disorders, Post-Traumatic; Moral Injury; Treatment

Outcome Measures

Primary Outcomes (2)

• World Health Organization Quality of Life-BREF

  A widely-validated, 26-item measure on a 5 point scale that assesses functioning in physical health, psychological health, social relationships, and environment, with higher scores indicating greater health in each domain. Each item is scored from 1-5, and a total raw score is calculated by summing all items (26-130). The total score is calculated by transforming the raw score to a 0-100 scale, with higher scores representing better quality of life.

  Change from baseline (Week 0) and post-treatment (Week 11)

• World Health Organization Quality of Life-BREF

  A widely-validated, 26-item measure on a 5 point scale that assesses functioning in physical health, psychological health, social relationships, and environment, with higher scores indicating greater health in each domain. Each item is scored from 1-5, and a total raw score is calculated by summing all items (26-130). The total score is calculated by transforming the raw score to a 0-100 scale, with higher scores representing better quality of life.

  Change from post-treatment (Week 11) to 6 month follow-up (6 months after post-treatment)

Secondary Outcomes (1)

• Clinician Administered PTSD Scale for DSM-5 (CAPS-5)

  Change from baseline (Week 0) and post-treatment (Week 11)

Other Outcomes (6)

• PTSD Checklist for DSM-5 (PCL-5)

  Change from baseline (Week 0) and post-treatment (Week 11)

• PTSD Checklist for DSM-5 (PCL-5)

  Change from post-treatment (Week 11) to 6 month follow-up (6 months after post-treatment)

• Brief Symptom Inventory (BSI)

  Change from baseline (Week 0) and post-treatment (Week 11)

Study Arms (2)

Impact of Killing (IOK)

EXPERIMENTAL

Participants in this arm will receive 10 sessions (60-90 minutes) of a cognitive-behavioral moral injury treatment called IOK .

Behavioral: Impact of Killing (IOK)

Present Centered Therapy

ACTIVE COMPARATOR

Participants in this arm will receive 10 sessions (60-90 minutes) of a PTSD treatment that does not focus on trauma or cognitive restructuring, but rather the functional impact of trauma called Present Center Therapy (PCT)

Behavioral: Present Centered Therapy

Interventions

Impact of Killing (IOK) BEHAVIORAL

Participants in this arm will receive 10 sessions (60-90 minutes) of a cognitive-behavioral moral injury treatment called IOK .

Impact of Killing (IOK)

Present Centered Therapy BEHAVIORAL

Participants in this arm will receive 10 sessions (60-90 minutes) of a PTSD treatment that does not focus on trauma or cognitive restructuring, but rather the functional impact of trauma called Present Center Therapy (PCT)

Present Centered Therapy

Eligibility Criteria

• Age: 18 Years - 82 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veterans 18-82 years of age
• Veterans who meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for Post-traumatic Stress Disorder (PTSD) or score 23 or higher on the Clinician-Administered PTSD Scale for DSM-5 (CAPS) screening interview.
• Veterans who endorsed killing or being responsible for the death of another in a war zone and report continued distress regarding these events
• Distress will be operationalized by a positive response to one or more of the nine self-directed moral injury items on the Expressions of Moral Injury Scale-Military Version (EMIS-M) or item #4 on the Moral Injury Events Scale (MIES)
• Veterans who have initiated or completed an evidence-based treatment for PTSD, such as Cognitive Processing Therapy (CPT) or Prolonged Exposure (PE)
• If receiving CPT or PE, Veterans must complete treatment and wait two weeks prior to screening
• If receiving prescription medication for PTSD, Veterans must be one month stable on medication and not make any changes to medication during the course of the active treatment phase of the study

You may not qualify if:

• Veterans with current or lifetime diagnosis of a psychotic disorder or current untreated/unmanaged mania.
• Veterans with recent psychiatric hospitalizations
• Veterans with moderate or severe alcohol or drug dependence within the past three months
• Veterans receiving individual therapy for PTSD or those planning to start skills-based or trauma-focused group psychotherapy will be excluded
• However, these Veterans will be offered the opportunity to be screened again after completion of individual PTSD therapy or once they are three months stable in group treatment, with no plans to discontinue this treatment

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (3)

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, 94121-1563, United States

Location

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, 10468, United States

Location

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Limitations and Caveats

The study began prior to the Covid-19 pandemic. Three participants completed all data collection procedures and treatment in-person before the pandemic lockdown. The remaining participants completed some (n=5) or all (n=92) study procedures during the pandemic, through video or in-person appointments (as restrictions were lifted) and paper or electronic data collection methods.

Results Point of Contact

• Title: Shira Maguen, PhD
• Organization: San Francisco VA Health Care System

Shira.Maguen@va.gov

415-221-4810

Study Officials

• Shira Maguen, PhD

  San Francisco VA Medical Center, San Francisco, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The clinical evaluators will be kept blind to treatment condition throughout the study period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: The investigators propose to conduct a multi-site, randomized, controlled trial to test the efficacy of an individual treatment for PTSD stemming from moral injury called IOK, compared to a present-centered therapy (PCT) control condition.

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 4, 2018
• Study Start: August 12, 2019
• Primary Completion: November 15, 2024
• Study Completion: December 31, 2024
• Last Updated: November 20, 2025
• Results First Posted: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)