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OpenTrials
Completed

NCT Number: NCT02512445

Trauma Informed Guilt Reduction Therapy

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.

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Key information

Conditions

Guilt Mental Disorders Post-Traumatic Stress Disorders Shame Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA San Diego Healthcare System, San Diego, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trauma Informed Guilt Reduction Therapy

Behavioral

Trauma focused therapy

Supportive Care Therapy

Behavioral

Supportive therapy

Primary outcomes

  1. 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

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

    Time frame: baseline to 8 months

    min = 0, max = 80 higher scores = more severe PTSD

  2. Change in Patient Health Questionnaire - 9 (PHQ-9)

    Time frame: baseline to 8 months

    The PHQ-9 measures severity of depression symptoms. Scores range 0 - 27 higher scores = more severe depression

  3. Change in Internalized Shame Scale

    Time frame: baseline to 8-month follow-up

    change in Internalized Shame Scale scores range 0 to 120 higher scores = greater internalized shame

  4. Change in World Health Organization Quality of Life - Brief

    Time frame: baseline to 8 months

    Change in World Health Organization Quality of Life - Brief - score range = 0-100 higher scores = better quality of life

  5. Change in Brief Symptom Inventory-18

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Veterans Medical Research Foundation

Other

Collaborators

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

Registry information

Acronym: TrIGR

Important dates

Study start
2015
Primary completion
2023
Study completion
2023
First posted
Jul 30, 2015
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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