Clinical Trials Logo
  1. Home
  2. Post-Traumatic Stress Disorders
  3. NCT02512445
  4. Details
NCT02512445 Clinical Trial

Trauma Informed Guilt Reduction Therapy

Post-traumatic Stress Disorders Clinical Trial

— TrIGR  

Official title:
Trauma Informed Guilt Reduction Therapy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02512445
Other study ID # 09054
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 2015
Est. completion date October 2023

Study information
Verified date May 2022
Source Veterans Medical Research Foundation
Contact Sonya Norman, PhD
Phone 858-552-8585
Email snorman@ucsd.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 188
Est. completion date October 2023
Est. primary completion date October 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Behavioral:
• Trauma Informed Guilt Reduction Therapy
Trauma focused therapy
• Supportive Care Therapy
Supportive therapy

Locations
Country Name City State
United States National Center for PTSD Boston Massachusetts
United States VA Providence Medical Center Providence Rhode Island
United States VA San Diego Healthcare System San Diego California

Sponsors (8)
Lead Sponsor Collaborator
Veterans Medical Research Foundation 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

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Trauma Related Guilt Inventory - Guilt Severity baseline to 8 months (for supplemental study of pandemic guilt in 2021, timeframe is baseline to 3 months)
Secondary Change in Clinician Administered post traumatic stress disorder (PTSD) Scale baseline to 8 months
Secondary Change in Patient Health Questionnaire - 9 baseline to 8 months
Secondary Internalized Shame Scale up to 6-months post-treatmetn follow-up
Secondary Change in World Health Organization Quality of Life - Brief baseline to 8 months
Secondary Change in Brief Symptom Inventory-18 baseline to 8 months
See also
  Status Clinical Trial Phase
Recruiting NCT04032301 - Repeated Ketamine Infusions for Comorbid PTSD and MDD in Veterans Phase 1
Withdrawn NCT00641173 - Early Intervention for Post Traumatic Stress Disorder (PTSD) N/A
Completed NCT00564317 - KIDNET vs Meditation/Relaxation - a Dissemination Randomized Controlled Trial for the Treatment of Traumatized Children After War in Sri Lanka Phase 3
Completed NCT00100490 - Immune and Endocrine Function in Post-Traumatic Stress Disorder N/A
Terminated NCT03605342 - Optimal Treatment of Veterans With PTSD and Comorbid OUD Phase 2
Terminated NCT02824445 - To Evaluate the Efficacy of EEG-guided Magnetic Resonant Therapy in War Veterans With Posttraumatic Stress Disorder N/A
Recruiting NCT03152175 - Posttraumatic Stress Disorders in Police, Correctional Service Officers, and 911 Operators Phase 2
Completed NCT02080351 - A Simple Cognitive Task to Reduce the Build-Up of Flashbacks After a Road Traffic Accident N/A
Completed NCT00974402 - Psychotherapy Treatment of Deployment-Related PTSD in Primary Care Settings N/A
Recruiting NCT00134446 - Transcranial Magnetic Stimulation for Post-Traumatic Stress Disorder Phase 4
Not yet recruiting NCT02384369 - Trial of Oral SNC-102 in Subjects With Combat-Related Posttraumatic Stress Disorder Phase 2
Completed NCT00120250 - Eszopiclone for Sleep Disturbance and Nightmares in Post-Traumatic Stress Disorder Phase 4
Completed NCT00039715 - Effects of Hydrocortisone in Patients With Post-Traumatic Stress Disorder N/A
Recruiting NCT04368689 - The Feasibility and Examination of the Effects of Floatation-based REST on a Community Sample With PTSD N/A
Completed NCT01060553 - Pilot of Acupuncture to Improve Quality of Life in Veterans With TBI and PTSD N/A
Completed NCT00227357 - The CORE Buprenorphine Project - An HIV Primary Care Program Demonstration N/A
Completed NCT02927288 - Identifying Biomarkers That Distinguish PTSD and mTBI Using Advanced Magnetic Resonance Spectroscopy N/A
Completed NCT01278316 - Rural Veterans With Post-traumatic Stress Disorder (PTSD) And Comorbid Mild Traumatic Brain Injury (TBI): A Feasibility Study N/A
Completed NCT00778960 - Mechanistic Pathways of Mindfulness Meditation in Post-traumatic Stress Disorder. N/A
Completed NCT00288314 - fMRI in Posttraumatic Stress Disorder (PTSD) During Working Memory Updating N/A