Non-Inferiority Trial of TrIGR for PTSD

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.

Conditions

PTSD

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Study Overview

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Study Details

Study overview

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.

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

Non-Inferiority Trial of TrIGR for PTSD

Condition
PTSD
Intervention / Treatment

-

Contacts and Locations

San Diego

VA San Diego Healthcare System, San Diego, CA, San Diego, California, United States, 92161-0002

Tampa

James A. Haley Veterans' Hospital, Tampa, FL, Tampa, Florida, United States, 33612

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

VA Office of Research and Development,

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

Study Record Dates

2027-09-30