Trauma Informed Guilt Reduction Therapy

NCT02512445 | Completed Results

• 1 other identifier: 09054
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Guilt; Shame; Post-traumatic Stress Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale - 5 (CAPS-5)

  baseline to 8 months

• Change in Patient Health Questionnaire - 9 (PHQ-9)

  baseline to 8 months

• Change in Internalized Shame Scale

  baseline to 8-month follow-up

• Change in World Health Organization Quality of Life - Brief

  baseline to 8 months

• Change in Brief Symptom Inventory-18

  baseline to 8 months

Study Arms (2)

Trauma Informed Guilt Reduction Therapy

EXPERIMENTAL

6-session psychotherapy intervention

Behavioral: Trauma Informed Guilt Reduction Therapy

Supportive Care Therapy

ACTIVE COMPARATOR

6-session psychotherapy intervention

Behavioral: Supportive Care Therapy

Interventions

Trauma Informed Guilt Reduction Therapy BEHAVIORAL

Trauma focused therapy

Trauma Informed Guilt Reduction Therapy

Supportive Care Therapy BEHAVIORAL

Supportive therapy

Supportive Care Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Veterans Medical Research Foundation: lead
• United States Department of Defense: collaborator
• Brown University: collaborator
• Seattle Institute for Biomedical and Clinical Research: collaborator
• White River Junction Veterans Affairs Medical Center: collaborator
• San Diego Veterans Healthcare System: collaborator
• Providence VA Medical Center: collaborator
• National Center for PTSD: collaborator

Study Sites (3)

VA San Diego Healthcare System

San Diego, California, 92161, United States

Location

National Center for PTSD

Boston, Massachusetts, 02130, United States

Location

VA Providence Medical Center

Providence, Rhode Island, 02908, United States

Location

Related Publications (2)

• McCue ML, Capone CC, Wachen JS, Harle KM, Davis BC, Panza KE, Lyons M, Luciano MT, Shea MT, Haller M, Galovski TE, Schnurr PP, Norman SB. Addressing pandemic-related guilt and shame in U.S. military veterans: A pilot randomized controlled trial of trauma-informed guilt reduction and supportive care therapy. Psychol Trauma. 2025 Oct 23:10.1037/tra0002036. doi: 10.1037/tra0002036. Online ahead of print.

  PMID: 41129362 DERIVED

• 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.

  PMID: 33326878 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Sonya Norman
• Organization: UCSD

snorman@ucsd.edu

858-518-8266

Study Officials

• Sonya B. Norman, PhD

  Veterans Medical Research Foundation

  PRINCIPAL INVESTIGATOR

• Christy Capone, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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

Model Details: 188 enrollment goal for primary study

Study Record Dates

• First Submitted: July 27, 2015
• First Posted: July 30, 2015
• Study Start: October 1, 2015
• Primary Completion: June 1, 2023
• Study Completion: October 1, 2023
• Last Updated: May 9, 2025
• Results First Posted: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)