RECRUITING

Trauma-Informed Guilt Reduction Therapy Compared to Prolonged Exposure

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to learn if receiving Trauma-Informed Guilt Reduction (TrIGR) Therapy is as effective as receiving Prolonged Exposure Therapy among veterans with PTSD and trauma related guilt. The main questions it aims to answer are: Will TrIGR be comparable to PE in terms of PTSD symptom reduction? Will it TrIGR be comparable to PE in improving functioning and reducing depression symptoms? Will it be superior in improving trauma-related guilt and shame?

Official Title

Clinical Effectiveness and Implementation of Trauma-Informed Guilt Reduction Therapy Compared to Prolonged Exposure (TrIGR)

Quick Facts

Study Start:2024-12-01
Study Completion:2027-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06296589

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * U.S. Veterans age 18 or older who served in the military since the start of Operation Enduring Freedom/Operation Iraqi Freedom; OEF/OIF)
  2. * meets diagnostic criteria for PTSD;
  3. * a score of 2 or higher ("true" to "extremely true") on feeling trauma-related guilt much or all of the time or scoring 3 or higher ("very true" or "extremely true") on at least one guilt cognition factor (hindsight bias/responsibility, wrongdoing, or lack of justification) on the Trauma Related Guilt Inventory
  4. * not currently receiving trauma-focused treatment such as PE or CPT
  5. * willingness to attend psychotherapy and assessment sessions
  1. * current risk of suicidal/homicidal behavior that requires immediate intervention
  2. * current severe substance use disorder (in the past two months) based on DSM-5 criteria
  3. * current unmanaged psychosis or mania
  4. * life threatening or unstable medical illness
  5. * inability to read

Contacts and Locations

Study Contact

Sonya Norman, PhD
CONTACT
858-518-8266
snorman@ucsd.edu
Kaitlyn Panza, PhD
CONTACT
858-552-8585
kaitlyn.panza@va.gov

Principal Investigator

Shannon Kehle-Forbes, PhD
PRINCIPAL_INVESTIGATOR
University of Minnesota

Study Locations (Sites)

Little Rock Veterans Health Care System (LRVHCS)
Little Rock, Arkansas, 72205
United States
Southeast Louisiana Veterans Health Care System (SLVHCS)
New Orleans, Louisiana, 70119
United States
William S. Middleton Memorial Hospital
Madison, Wisconsin, 53705
United States

Collaborators and Investigators

Sponsor: Veterans Medical Research Foundation

  • Shannon Kehle-Forbes, PhD, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-01
Study Completion Date2027-08

Study Record Updates

Study Start Date2024-12-01
Study Completion Date2027-08

Terms related to this study

Additional Relevant MeSH Terms

  • Stress Disorders, Post-Traumatic