Comparing a brief therapy for PTSD to standard treatment
Non-Inferiority Trial of Trauma Informed Guilt Reduction Therapy (TrIGR) for PTSD
This study is testing a new, shorter therapy for PTSD called TrIGR to see if it helps U.S. Veterans just as much as the longer standard treatment, Cognitive Processing Therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 158 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 2 sites (San Diego, California and 1 other locations) |
| Trial ID | NCT05789329 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of Trauma Informed Guilt Reduction Therapy (TrIGR) in treating PTSD among U.S. Veterans. It aims to determine if TrIGR is as effective as the longer Cognitive Processing Therapy (CPT), which is commonly used but often leads to high dropout rates. The study will involve 158 Veterans who will be randomized to receive either TrIGR or CPT, with assessments focusing on changes in PTSD, depression, guilt, and shame symptoms. The goal is to find a less burdensome treatment option that can still provide significant relief for Veterans suffering from trauma-related guilt.
Who should consider this trial
Good fit: Ideal candidates for this study are U.S. Veterans aged 18 or older who meet the diagnostic criteria for PTSD and experience significant trauma-related guilt.
Not a fit: Patients with severe mental health issues, such as unmanaged psychosis or significant suicidal risk, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accessible and effective treatment option for Veterans with PTSD.
How similar studies have performed: While there have been successful studies on PTSD treatments, this specific non-inferiority trial of TrIGR is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* U.S. Veterans age 18 or older;
* meets diagnostic criteria for PTSD or subthreshold 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 Inventor.
* not currently receiving trauma-focused treatment such as CPT or PE; and
* willingness to attend psychotherapy and assessment sessions.
Exclusion Criteria:
* Impaired mental status as measured by the Montreal Cognitive Assessment (MoCA) (score \< 21) and confirmed by a neuropsychologist,
* Veterans with significant current risk of suicidal/homicidal behavior will be referred to more appropriate treatment;
* 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; or
* inability to read.
Where this trial is running
San Diego, California and 1 other locations
- VA San Diego Healthcare System, San Diego, CA — San Diego, California, United States (Recruiting)
- James A. Haley Veterans' Hospital, Tampa, FL — Tampa, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Sonya B. Norman, PhD — VA San Diego Healthcare System, San Diego, CA
- Study coordinator: Sonya B Norman, PhD
- Email: Sonya.Norman@va.gov
- Phone: (858) 552-8585
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.