Comparing Trauma-Informed Guilt Reduction Therapy to Prolonged Exposure for PTSD
Clinical Effectiveness and Implementation of Trauma-Informed Guilt Reduction Therapy Compared to Prolonged Exposure (TrIGR)
This study is testing whether a new therapy for guilt can help veterans with PTSD just as well as a traditional therapy that focuses on exposure to traumatic memories.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 158 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Veterans Medical Research Foundation Academic / other |
| Locations | 3 sites (Little Rock, Arkansas and 2 other locations) |
| Trial ID | NCT06296589 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of Trauma-Informed Guilt Reduction (TrIGR) Therapy compared to Prolonged Exposure (PE) Therapy in veterans suffering from PTSD and trauma-related guilt. The study will assess whether TrIGR, which consists of six sessions, is as effective as the more traditional PE, which consists of twelve sessions, in reducing PTSD symptoms, improving psychosocial functioning, and alleviating depression. Additionally, it will explore the potential superiority of TrIGR in addressing trauma-related guilt and shame. Participants will be U.S. veterans who meet specific diagnostic criteria and are not currently receiving other trauma-focused treatments.
Who should consider this trial
Good fit: Ideal candidates for this study are U.S. veterans aged 18 or older who have been diagnosed with PTSD and experience significant trauma-related guilt.
Not a fit: Patients who are currently at risk of suicidal behavior, have severe substance use disorders, or are receiving other trauma-focused treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more efficient and targeted therapy option for veterans with PTSD and trauma-related guilt.
How similar studies have performed: Preliminary research suggests that similar approaches targeting trauma-related guilt have shown promise, but this specific comparison of TrIGR to PE is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Little Rock, Arkansas and 2 other locations
- Little Rock Veterans Health Care System (LRVHCS) — Little Rock, Arkansas, United States (Recruiting)
- Southeast Louisiana Veterans Health Care System (SLVHCS) — New Orleans, Louisiana, United States (Recruiting)
- William S. Middleton Memorial Hospital — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Shannon Kehle-Forbes, PhD — University of Minnesota
- Study coordinator: Sonya Norman, PhD
- Email: snorman@ucsd.edu
- Phone: 858-518-8266
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.