Trauma-Informed Guilt Reduction Therapy Compared to Prolonged Exposure (PORT)

Clinical Effectiveness and Implementation of Trauma-Informed Guilt Reduction Therapy Compared to Prolonged Exposure (TrIGR)

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?

Study Overview

• Status: Not yet recruiting
• Conditions: Stress Disorders, Post-Traumatic
• Intervention / Treatment: Behavioral: Trauma Informed Guilt Reduction Therapy; Behavioral: Prolonged Exposure Therapy

Detailed Description

Trauma-related guilt is common and impairing among trauma survivors. Guilt is positively associated with severity of PTSD and depression symptoms, poorer psychosocial functioning and suicide risk. Although existing evidence-based trauma-focused PTSD treatments such as Prolonged Exposure (PE) are effective in treating PTSD and trauma-related guilt, many still experience symptoms or maintain their diagnosis after treatment. Preliminary research shows that a brief treatment targeting trauma-related and moral injury-related guilt and shame, Trauma Informed Guilt Reduction Therapy (TrIGR), can reduce guilt, PTSD, depression, and distress among Veterans and help them reengage with meaningful activities. Whether TrIGR is comparably effective to longer, more resource heavy evidence-based PTSD treatments disseminated across DoD and VA, like PE, is a critical question.

The proposed randomized clinical trial aims to determine if TrIGR is non-inferior to a first tier PTSD treatment, PE. Hypotheses are that 6 sessions of TrIGR will be non-inferior to 12 sessions of PE in reducing PTSD symptom severity among Veterans with PTSD who endorse trauma-related guilt. Secondary aims are to evaluate the hypotheses that TrIGR will be non-inferiority relative to PE in improving psychosocial functioning and depression symptoms and superior in reducing trauma-related guilt and shame. The study will also explore treatment differences in change in suicidal ideation and dropout.

Participants will be recruited from mental health clinics across three VAs. 158 Veterans who served since 9/11 and with PTSD and guilt from any type of trauma will be included. TrIGR will be administered over 6 weekly sessions (60-minutes each) and PE will be administered over 12 weekly sessions (90 minutes each). Blind assessors will evaluate participants at baseline and 8-, 16-, and 28 weeks after the first therapy session. Inclusion and exclusion criteria are minimized so that generalizability will be high.

• Study Type: Interventional
• Enrollment (Estimated): 158
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sonya Norman, PhD; Phone Number: 858-518-8266; Email: snorman@ucsd.edu
• Study Contact Backup: Name: Kaitlyn Panza, PhD; Phone Number: 858-552-8585; Email: kaitlyn.panza@va.gov

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Little Rock Veterans Health Care System (LRVHCS)
      • Contact: Brandon Griffin; Phone Number: 501-257-1000; Email: Brandon.Griffin2@va.gov
  • Louisiana
    • New Orleans, Louisiana, United States, 70119
      • Southeast Louisiana Veterans Health Care System (SLVHCS)
      • Contact: Laurel Franklin, PhD; Phone Number: 800-935-8387; Email: Laurel.Franklin@va.gov
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • William S. Middleton Memorial Hospital
      • Contact: Michael Messina, PhD; Phone Number: 608-284-6302; Email: Michael.Messina2@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: trauma Informed Guilt Reduction Therapy; 6 session behavioral intervention focused on trauma-related guilt, shame, and moral injury	Behavioral: Trauma Informed Guilt Reduction Therapy; Behavioral therapy for trauma related guilt and shame
Active Comparator: Prolonged Exposure Therapy; 12 session behavioral intervention focused on PTSD symptoms	Behavioral: Prolonged Exposure Therapy; Behavioral exposure therapy for PTSD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire-9 (PHQ-9)	Depression symptom severity, range = 0-27, higher scores mean greater depression symptom severity	baseline and 8-, 16-, and 28 weeks after the first therapy session
Brief Psychosocial Functioning Inventory (B-IPF)	Measures severity of impairment in psychosocial functioning, scores = 0-100, higher scores indicate greater impairment	baseline and 8-, 16-, and 28 weeks after the first therapy session
Trauma Related Guilt Inventory Cognitions Scale (TRGI)	Measures severity of trauma related guilt cognitions, scores = 0-4, higher scores indicate greater guilt	baseline and 8-, 16-, and 28 weeks after the first therapy session
Trauma Related Shame Inventory (TRSI)	Measures severity of trauma related shame, scores = 0-96, higher scores indicate greater shame	baseline and 8-, 16-, and 28 weeks after the first therapy session

Collaborators and Investigators

• Sponsor: Veterans Medical Research Foundation
• Collaborators: University of Minnesota; Center for Veterans Research and Education
• Investigators: Principal Investigator: Shannon Kehle-Forbes, PhD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: February 28, 2024
• First Submitted That Met QC Criteria: February 28, 2024
• First Posted (Estimated): March 6, 2024

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: HT94252310861

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Will share data with Strong Star Repository.
• IPD Sharing Time Frame: After study completion.
• IPD Sharing Access Criteria: Request to StrongStar Repository that Strong Star must approve.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No