Trauma Informed Guilt Reduction Therapy

Not Applicable

Completed

• Conditions: Guilt; Post-traumatic Stress Disorders; Shame
• Interventions: Behavioral: Supportive Care Therapy; Behavioral: Trauma Informed Guilt Reduction Therapy

• Registration Number: NCT02512445
• Lead Sponsor: Veterans Medical Research Foundation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-27
• Study First Submitted QC: 2015-07-29
• Study First Posted: 2015-07-30
• Study Start: 2015-10
• Primary Completion: 2023-06
• Study Completion: 2023-10
• Results First Submitted: 2024-02-28
• Status Verified: 2025-05
• Results First Submitted QC: 2025-05-08
• Last Update Submitted: 2025-05-08
• Results First Posted: 2025-05-09
• Last Update Posted: 2025-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supportive Care Therapy	Supportive Care Therapy	6-session psychotherapy intervention
Trauma Informed Guilt Reduction Therapy	Trauma Informed Guilt Reduction Therapy	6-session psychotherapy intervention

Primary Outcome Measures

Name	Time	Method
Trauma Related Guilt Inventory - Guilt Severity	baseline to 8 months	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

Secondary Outcome Measures

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

Trial Locations

Locations (3)

VA San Diego Healthcare System; 🇺🇸 San Diego, California, United States

National Center for PTSD; 🇺🇸 Boston, Massachusetts, United States

VA Providence Medical Center; 🇺🇸 Providence, Rhode Island, United States