Trauma Informed Guilt Reduction Therapy (TrIGR)

The goal of this project is to determine if a 6-session psychotherapy intervention will help Veterans feel less deployment-related guilt and less distress related to their guilt. Half of the participants will receive the guilt focused intervention and half will receive a supportive intervention. A supplemental pilot study added in FY2021 will examine the intervention for pandemic-related guilt events.

Study Overview

• Status: Completed
• Conditions: Post-traumatic Stress Disorders; Guilt; Shame
• Intervention / Treatment: Behavioral: Trauma Informed Guilt Reduction Therapy; Behavioral: Supportive Care Therapy

• Study Type: Interventional
• Enrollment (Actual): 145
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92161
      • VA San Diego Healthcare System
  • Massachusetts
    • Boston, Massachusetts, United States, 02130
      • National Center for PTSD
  • Rhode Island
    • Providence, Rhode Island, United States, 02908
      • VA Providence Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participant Served in OEF/OIF/OND, has post-traumatic guilt related to deployment event (for pandemic supplement in 2021, has guilt related to pandemic event)

Exclusion Criteria:

• Moderate or severe cognitive impairment, acute suicidality, current severe substance use disorder, unmanaged psychosis or mania

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 psychotherapy intervention	Behavioral: Trauma Informed Guilt Reduction Therapy; Trauma focused therapy
Active Comparator: Supportive Care Therapy; 6-session psychotherapy intervention	Behavioral: Supportive Care Therapy; Supportive therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trauma Related Guilt Inventory - Guilt Severity	Change in Trauma Related Guilt Inventory - Guilt Severity Subscale Min score = 0, max score = 4 (score = mean of all items in subscale) higher scores = greater trauma related guilt severity	baseline to 8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale - 5 (CAPS-5)	min = 0, max = 80 higher scores = more severe PTSD	baseline to 8 months
Change in Patient Health Questionnaire - 9 (PHQ-9)	The PHQ-9 measures severity of depression symptoms. Scores range 0 - 27 higher scores = more severe depression	baseline to 8 months
Change in Internalized Shame Scale	change in Internalized Shame Scale scores range 0 to 120 higher scores = greater internalized shame	baseline to 8-month follow-up
Change in World Health Organization Quality of Life - Brief	Change in World Health Organization Quality of Life - Brief - score range = 0-100 higher scores = better quality of life	baseline to 8 months
Change in Brief Symptom Inventory-18	Change in Brief Symptom Inventory-18, a measure of depression, anxiety, and somatic symptoms score range = 0 - 72 higher scores = greater distress	baseline to 8 months

Collaborators and Investigators

• Sponsor: Veterans Medical Research Foundation
• Collaborators: United States Department of Defense; Brown University; Seattle Institute for Biomedical and Clinical Research; White River Junction Veterans Affairs Medical Center; San Diego Veterans Healthcare System; Providence VA Medical Center; National Center for PTSD
• Investigators: Principal Investigator: Sonya B. Norman, PhD, Veterans Medical Research Foundation; Principal Investigator: Christy Capone, PhD, Brown University

Publications and helpful links

General Publications

• Capone C, Norman SB, Haller M, Davis B, Shea MT, Browne K, Lang AJ, Schnurr PP, Golshan S, Afari N, Pittman J, Allard CB, Westendorf L. Trauma Informed Guilt Reduction (TrIGR) therapy for guilt, shame, and moral injury resulting from trauma: Rationale, design, and methodology of a two-site randomized controlled trial. Contemp Clin Trials. 2021 Feb;101:106251. doi: 10.1016/j.cct.2020.106251. Epub 2020 Dec 14.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: July 27, 2015
• First Submitted That Met QC Criteria: July 29, 2015
• First Posted (Estimated): July 30, 2015

Study Record Updates

• Last Update Posted (Actual): May 9, 2025
• Last Update Submitted That Met QC Criteria: May 8, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 09054

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO