Non-Inferiority Trial of TrIGR for PTSD
TrIGR/CPT
Non-Inferiority Trial of Trauma Informed Guilt Reduction Therapy (TrIGR) for PTSD
2 other identifiers
interventional
158
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2023
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2023
CompletedFirst Posted
Study publicly available on registry
March 29, 2023
CompletedStudy Start
First participant enrolled
June 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2027
June 26, 2025
June 1, 2025
3.8 years
March 15, 2023
June 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change in Clinician Administered PTSD Scale - 5 (CAPS-5)
Clinician Administered PTSD Scale - 5 (CAPS-5) - score range 0 - 80; higher scores are indicative of more severe PTSD symptoms. Reduction in scores is considered a positive outcome.
baseline to 28 weeks later
Secondary Outcomes (3)
change in Patient Health Questionnaire - 9 (PHQ-9)
baseline to 28 weeks later
Trauma Related Guilt Inventory (TRGI)
baseline to 28 weeks later
Trauma Related Shame Inventory (TRSI)
baseline to 28 weeks later
Study Arms (2)
Trauma Informed Guilt Reduction Therapy (TrIGR)
EXPERIMENTALbehavioral intervention aimed to reduce trauma-related guilt and shame
Cognitive Processing Therapy (CPT)
ACTIVE COMPARATORbehavioral intervention aimed at reducing PTSD symptoms
Interventions
behavioral intervention aimed to reduce trauma-related guilt and shame
behavioral intervention aimed at reducing PTSD symptoms
Eligibility Criteria
You may qualify if:
- 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 may not qualify 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sonya B. Norman, PhD
VA San Diego Healthcare System, San Diego, CA
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- A computer-generated masked randomization sequence will be provided and held by a statistician not otherwise involved in the study. Randomization will be stratified by site and gender.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2023
First Posted
March 29, 2023
Study Start
June 1, 2023
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
September 30, 2027
Last Updated
June 26, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- After publication of the primary outcome paper.
- Access Criteria
- Requests for access must be made in writing signed by a requester from the United States and include an email address for delivery and an assurance that the recipient will not attempt to identify or re-identify any individual. The request should reference the publication underlying the request.
A de-identified, anonymized dataset without personal identifiers will be generated and shared with those who request and are granted access (see access criteria). Any HIPAA identifiers, or combinations of variables that could be used for re-identification, will be excluded, as will any proprietary information. The plan does not include any access to individually identifiable or proprietary data. Therefore, this plan will ensure the protection of personal privacy, the confidentiality of individually identifiable private information, and the security of proprietary data and information.