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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• U.S. Veterans age 18 or older;

• meets diagnostic criteria for PTSD or subthreshold PTSD;

• 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.

• not currently receiving trauma-focused treatment such as CPT or PE; and

• willingness to attend psychotherapy and assessment sessions.

Locations
United States
California
VA San Diego Healthcare System, San Diego, CA
RECRUITING
San Diego
Florida
James A. Haley Veterans' Hospital, Tampa, FL
RECRUITING
Tampa
Contact Information
Primary
Sonya B Norman, PhD
Sonya.Norman@va.gov
(858) 552-8585
Backup
Kaitlyn Panza, PhD
kaitlyn.panza@va.gov
(858) 552-8585
Time Frame
Start Date: 2023-06-01
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 158
Treatments
Experimental: Trauma Informed Guilt Reduction Therapy (TrIGR)
behavioral intervention aimed to reduce trauma-related guilt and shame
Active_comparator: Cognitive Processing Therapy (CPT)
behavioral intervention aimed at reducing PTSD symptoms
Related Therapeutic Areas
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov