Recruiting

Trauma-Informed Guilt Reduction Therapy vs. Prolonged Exposure

Sponsor:

Veterans Medical Research Foundation

Code:

NCT06296589

Conditions

Stress Disorders, Post-Traumatic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Trauma Informed Guilt Reduction Therapy

Prolonged Exposure Therapy

Study Details

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?

Conditions

Stress Disorders, Post-Traumatic

Study ID

NCT06296589

Start date

Dec 1, 2024

Status verified date

Aug, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

158 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: trauma Informed Guilt Reduction Therapy

6 session behavioral intervention focused on trauma-related guilt, shame, and moral injury

active comparator: Prolonged Exposure Therapy

12 session behavioral intervention focused on PTSD symptoms

Interventions

Trauma Informed Guilt Reduction Therapy

Behavioral therapy for trauma related guilt and shame

Prolonged Exposure Therapy

Behavioral exposure therapy for PTSD

Primary outcome measure

  • Clinician Administered PTSD Scale for DSM-5 (CAPS-5) [ Time Frame: baseline and 8-, 16-, and 28 weeks after the first therapy session ]

Central Contacts and Locations

Central contacts

Sonya Norman, PhD

858-518-8266snorman@ucsd.edu

Kaitlyn Panza, PhD

858-552-8585kaitlyn.panza@va.gov

Locations

Little Rock Veterans Health Care System (LRVHCS)

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Brandon Griffin

(501) 257-1000Brandon.Griffin2@va.gov

VA San Diego

Recruiting

San Diego, California, United States, 92161

Contacts

Kaitlyn Panza

858-552-8585kaitlyn.panza@va.gov

Principal Investigator:

Kaitlyn Panza, PhD

Southeast Louisiana Veterans Health Care System (SLVHCS)

Recruiting

New Orleans, Louisiana, United States, 70119

Contacts

Laurel Franklin, PhD

800-935-8387Laurel.Franklin@va.gov

William S. Middleton Memorial Hospital

Recruiting

Madison, Wisconsin, United States, 53705

Contacts

Michael Messina, PhD

608-284-6302Michael.Messina2@va.gov

More Information

Sponsor

Veterans Medical Research Foundation

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Veterans Medical Research Foundation on 2026-08-25.