NCT06296589

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?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P75+ for not_applicable

Timeline
15mo left

Started Dec 2024

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress54%
Dec 2024Aug 2027

First Submitted

Initial submission to the registry

February 28, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 6, 2024

Completed
9 months until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

April 22, 2025

Status Verified

April 1, 2025

Enrollment Period

2.6 years

First QC Date

February 28, 2024

Last Update Submit

April 16, 2025

Conditions

Stress Disorders, Post-Traumatic

Outcome Measures

Primary Outcomes (1)

  • Clinician Administered PTSD Scale for DSM-5 (CAPS-5)

    Measures PTSD symptom severity, score range 0-80, higher scores mean greater symptom severity

    baseline and 8-, 16-, and 28 weeks after the first therapy session

Secondary Outcomes (4)

  • Patient Health Questionnaire-9 (PHQ-9)

    baseline and 8-, 16-, and 28 weeks after the first therapy session

  • Brief Psychosocial Functioning Inventory (B-IPF)

    baseline and 8-, 16-, and 28 weeks after the first therapy session

  • Trauma Related Guilt Inventory Cognitions Scale (TRGI)

    baseline and 8-, 16-, and 28 weeks after the first therapy session

  • Trauma Related Shame Inventory (TRSI)

    baseline and 8-, 16-, and 28 weeks after the first therapy session

Study Arms (2)

trauma Informed Guilt Reduction Therapy

EXPERIMENTAL

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

Behavioral: Trauma Informed Guilt Reduction Therapy

Prolonged Exposure Therapy

ACTIVE COMPARATOR

12 session behavioral intervention focused on PTSD symptoms

Behavioral: Prolonged Exposure Therapy

Interventions

Trauma Informed Guilt Reduction TherapyBEHAVIORAL

Behavioral therapy for trauma related guilt and shame

trauma Informed Guilt Reduction Therapy
Prolonged Exposure TherapyBEHAVIORAL

Behavioral exposure therapy for PTSD

Prolonged Exposure Therapy

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Little Rock Veterans Health Care System (LRVHCS)

Little Rock, Arkansas, 72205, United States

RECRUITING

Southeast Louisiana Veterans Health Care System (SLVHCS)

New Orleans, Louisiana, 70119, United States

RECRUITING

William S. Middleton Memorial Hospital

Madison, Wisconsin, 53705, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Shannon Kehle-Forbes, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sonya Norman, PhD

CONTACT

858-518-8266snorman@ucsd.edu

Kaitlyn Panza, PhD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2024

First Posted

March 6, 2024

Study Start

December 1, 2024

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

April 22, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

Will share data with Strong Star Repository.

Shared Documents
STUDY PROTOCOL
Time Frame
After study completion.
Access Criteria
Request to StrongStar Repository that Strong Star must approve.
More information

Locations

US(3)