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RecruitingNot ApplicableNCT05789329

Non-Inferiority Trial of TrIGR for PTSD

Non-Inferiority Trial of Trauma Informed Guilt Reduction Therapy (TrIGR) for PTSD

Sponsor

VA Office of Research and Development

Enrollment

158 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

PTSD

Summary

Trauma-related guilt is common and impairing among trauma survivors, particularly among Veterans with posttraumatic stress disorder (PTSD). The investigators' work shows that a brief treatment targeting trauma-related guilt, Trauma Informed Guilt Reduction Therapy (TrIGR), can reduce guilt and PTSD and depression symptoms. Whether TrIGR is no less effective than longer, more resource heavy PTSD treatments disseminated by by VA, like cognitive processing therapy (CPT), is the next critical question that this study will seek to answer. 158 Veterans across two VA sites will be randomized to TrIGR or CPT to evaluate changes in PTSD, depression, guilt and shame symptoms across the two treatments.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a newer, shorter trauma therapy called TrIGR (Trauma-Informed Guilt Reduction therapy) for veterans with PTSD, specifically those who experience significant trauma-related guilt. Researchers want to see if TrIGR works as well as existing standard therapies. **You may be eligible if...** - You are a U.S. Veteran aged 18 or older - You meet diagnostic criteria for PTSD or have significant PTSD symptoms - You experience significant trauma-related guilt (feeling you did something wrong, or could have done more) - You are not currently receiving trauma-focused therapy - You are willing to attend therapy and assessment sessions **You may NOT be eligible if...** - You have significant cognitive impairment - You are at serious risk of harming yourself or others - You have a severe substance use disorder in the past 2 months - You have current, unmanaged psychosis or mania - You have a life-threatening or unstable medical condition - You are unable to read Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALTrauma Informed Guilt Reduction Therapy

behavioral intervention aimed to reduce trauma-related guilt and shame

BEHAVIORALCognitive Processing Therapy

behavioral intervention aimed at reducing PTSD symptoms

Locations(2)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, United States

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, United States

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NCT05789329

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