RECRUITING

Non-Inferiority Trial of TrIGR for PTSD

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

Trauma-related guilt is common and impairing among trauma survivors, particularly among Veterans with posttraumatic stress disorder (PTSD). The investigators' work shows that a brief treatment targeting trauma-related guilt, Trauma Informed Guilt Reduction Therapy (TrIGR), can reduce guilt and PTSD and depression symptoms. Whether TrIGR is no less effective than longer, more resource heavy PTSD treatments disseminated by by VA, like cognitive processing therapy (CPT), is the next critical question that this study will seek to answer. 158 Veterans across two VA sites will be randomized to TrIGR or CPT to evaluate changes in PTSD, depression, guilt and shame symptoms across the two treatments.

Official Title

Non-Inferiority Trial of Trauma Informed Guilt Reduction Therapy (TrIGR) for PTSD

Quick Facts

Study Start:2023-06-01
Study Completion:2027-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05789329

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;
  2. * meets diagnostic criteria for PTSD or subthreshold 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 Inventor.
  4. * not currently receiving trauma-focused treatment such as CPT or PE; and
  5. * willingness to attend psychotherapy and assessment sessions.
  1. * Impaired mental status as measured by the Montreal Cognitive Assessment (MoCA) (score \< 21) and confirmed by a neuropsychologist,
  2. * Veterans with significant current risk of suicidal/homicidal behavior will be referred to more appropriate treatment;
  3. * Current severe substance use disorder (in the past two months) based on DSM-5 criteria;
  4. * Current unmanaged psychosis or mania;
  5. * life threatening or unstable medical illness; or
  6. * inability to read.

Contacts and Locations

Study Contact

Sonya B Norman, PhD
CONTACT
(858) 552-8585
Sonya.Norman@va.gov
Kaitlyn Panza, PhD
CONTACT
(858) 552-8585
kaitlyn.panza@va.gov

Principal Investigator

Sonya B. Norman, PhD
PRINCIPAL_INVESTIGATOR
VA San Diego Healthcare System, San Diego, CA

Study Locations (Sites)

VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002
United States
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, 33612
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Sonya B. Norman, PhD, PRINCIPAL_INVESTIGATOR, VA San Diego Healthcare System, San Diego, CA

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 Date2023-06-01
Study Completion Date2027-09-30

Study Record Updates

Study Start Date2023-06-01
Study Completion Date2027-09-30

Terms related to this study

Keywords Provided by Researchers

  • PTSD
  • trauma
  • moral injury
  • intervention
  • guilt
  • shame

Additional Relevant MeSH Terms

  • PTSD