NCT06296589 Trauma-Informed Guilt Reduction Therapy Compared to Prolonged Exposure
| NCT ID | NCT06296589 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Veterans Medical Research Foundation |
| Condition | Stress Disorders, Post-Traumatic |
| Study Type | INTERVENTIONAL |
| Enrollment | 158 participants |
| Start Date | 2024-12-01 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 158 participants in total. It began in 2024-12-01 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to learn if receiving Trauma-Informed Guilt Reduction (TrIGR) Therapy is as effective as receiving Prolonged Exposure Therapy among veterans with PTSD and trauma related guilt. The main questions it aims to answer are: Will TrIGR be comparable to PE in terms of PTSD symptom reduction? Will it TrIGR be comparable to PE in improving functioning and reducing depression symptoms? Will it be superior in improving trauma-related guilt and shame?
Eligibility Criteria
Inclusion Criteria: * U.S. Veterans age 18 or older who served in the military since the start of Operation Enduring Freedom/Operation Iraqi Freedom; OEF/OIF) * meets diagnostic criteria for PTSD; * a score of 2 or higher ("true" to "extremely true") on feeling trauma-related guilt much or all of the time or scoring 3 or higher ("very true" or "extremely true") on at least one guilt cognition factor (hindsight bias/responsibility, wrongdoing, or lack of justification) on the Trauma Related Guilt Inventory * not currently receiving trauma-focused treatment such as PE or CPT * willingness to attend psychotherapy and assessment sessions Exclusion Criteria: * current risk of suicidal/homicidal behavior that requires immediate intervention * current severe substance use disorder (in the past two months) based on DSM-5 criteria * current unmanaged psychosis or mania * life threatening or unstable medical illness * inability to read
Contact & Investigator
Shannon Kehle-Forbes, PhD
PRINCIPAL INVESTIGATOR
University of Minnesota
Frequently Asked Questions
Who can join the NCT06296589 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stress Disorders, Post-Traumatic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06296589 currently recruiting?
Yes, NCT06296589 is actively recruiting participants. Contact the research team at snorman@ucsd.edu for enrollment information.
Where is the NCT06296589 trial being conducted?
This trial is being conducted at Little Rock, United States, New Orleans, United States, Madison, United States.
Who is sponsoring the NCT06296589 clinical trial?
NCT06296589 is sponsored by Veterans Medical Research Foundation. The principal investigator is Shannon Kehle-Forbes, PhD at University of Minnesota. The trial plans to enroll 158 participants.