Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05789329

Non-Inferiority Trial of TrIGR for PTSD

Led by VA Office of Research and Development · Updated on 2025-06-26

158

Participants Needed

2

Research Sites

226 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Non-Inferiority Trial of TrIGR for PTSD

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • U.S. Veterans age 18 or older
  • Meets diagnostic criteria for PTSD or subthreshold PTSD
  • Scores 2 or higher on feeling trauma-related guilt much or all of the time or scores 3 or higher on at least one guilt cognition factor on the Trauma Related Guilt Inventory
  • Not currently receiving trauma-focused treatment such as CPT or PE
  • Willingness to attend psychotherapy and assessment sessions
Not Eligible

You will not qualify if you...

  • Impaired mental status as measured by the Montreal Cognitive Assessment (MoCA) with a score less than 21, confirmed by a neuropsychologist
  • Significant current risk of suicidal or homicidal behavior
  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

VA San Diego Healthcare System, San Diego, CA

San Diego, California, United States, 92161-0002

Actively Recruiting

2

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, United States, 33612

Actively Recruiting

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Research Team

S

Sonya B Norman, PhD

CONTACT

K

Kaitlyn Panza, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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