Trauma Informed Guilt Reduction Therapy

Veterans Medical Research Foundation3 sites in 1 country145 target enrollmentOctober 2015

ConditionsGuilt Shame Post-traumatic Stress Disorders

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Guilt
Sponsor: Veterans Medical Research Foundation
Enrollment: 145
Locations: 3
Primary Endpoint: Trauma Related Guilt Inventory - Guilt Severity
Status: Completed
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2015

End Date

October 2023

Last Updated

11 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Veterans Medical Research Foundation

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Trauma Related Guilt Inventory - Guilt Severity

Time Frame: 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 Outcomes

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)