Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Diego, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Sonya B. Norman, PhD
Headshot of Sonya B. Norman
Sonya B. Norman

Description

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.

Official Title

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

Details

Trauma-related guilt is common and impairing among trauma survivors, particularly among treatment seeking Veterans with posttraumatic stress disorder (PTSD). Although evidence-based trauma-focused PTSD treatments such as Cognitive Processing Therapy (CPT) are effective to treat PTSD and trauma-related guilt, many still experience symptoms or maintain their diagnosis after treatment, and dropout from these generally 12+ session protocols is high. Veterans show lower response and higher dropout than others with PTSD. Delivering protocols that are generally 12 or more sessions challenges the Veterans Affairs (VA) healthcare system given high demand for mental health care. For these reasons, additional and less burdensome approaches are needed. Brief treatment that targets mechanisms that are distressing and associated with multiple problems and disorders may be an understudied but promising way to treat PTSD and other posttraumatic psychopathology. The investigators' work shows that a brief treatment targeting trauma-related guilt and shame, Trauma Informed Guilt Reduction Therapy (TrIGR), can reduce guilt, PTSD, depression, and distress among Veterans and help them reengage with activities they find meaningful. Whether TrIGR is no less effective than longer, more resource heavy evidence-based PTSD treatments disseminated across by VA, like CPT, is the next critical question.

The proposed randomized clinical trial (RCT) will be the first non-inferiority trial of TrIGR and the first to compare TrIGR to a first tier PTSD treatment, specifically CPT. It will also be the first to evaluate TrIGR with Veterans from all eras with guilt from any type of traumas, as the investigators previous work was exclusively with Veterans of the conflicts in Iraq and Afghanistan with deployment-related traumas. 158 Veterans across two VA sites will be randomized to TrIGR or CPT. Exclusion criteria will be minimal so that generalizability will be high. Treatment will be delivered in VA mental health clinics. The primary aim is to evaluate if TrIGR is non-inferior to CPT in reducing PTSD symptom severity among Veterans with PTSD who endorse trauma-related guilt. Secondary aims are to evaluate TrIGR's non-inferiority relative to CPT regarding depression severity. The investigators will explore potential mechanisms of treatment, such as the relationship between change in guilt and shame change in PTSD symptoms. The study is critical to establish whether TrIGR is effective for a much larger group of Veterans and whether it is as effective as longer treatments already available in VA to inform if TrIGR warrants further study and dissemination in VA.

Keywords

PTSD, trauma, moral injury, intervention, guilt, shame, Post-Traumatic Stress Disorders, Trauma Informed Guilt Reduction Therapy, Cognitive Processing Therapy, Cognitive Processing Therapy (CPT)

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • Impaired mental status as measured by the Montreal Cognitive Assessment (MoCA) (score < 21) and confirmed by a neuropsychologist,
  • Veterans with significant current risk of suicidal/homicidal behavior will be referred to more appropriate treatment;
  • Current severe substance use disorder (in the past two months) based on DSM-5 criteria;
  • Current unmanaged psychosis or mania;
  • life threatening or unstable medical illness; or
  • inability to read.

Locations

  • 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

Lead Scientist at UCSD

  • Sonya B. Norman, PhD
    SONYA NORMAN, PhD, Professor of Psychiatry at the University of California San Diego School of Medicine and director of the PTSD Consultation Program for the National Center for PTSD, is a clinical psychologist and a researcher in the treatment of PTSD and addictions, and novel treatments to address trauma-related guilt, shame, and moral injury.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
VA Office of Research and Development
ID
NCT05789329
Study Type
Interventional
Participants
Expecting 158 study participants
Last Updated