Non-Inferiority Trial of TrIGR for PTSD (TrIGR/CPT)

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

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.

Study Overview

• Status: Recruiting
• Conditions: PTSD
• Intervention / Treatment: Behavioral: Trauma Informed Guilt Reduction Therapy; Behavioral: Cognitive Processing Therapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 158
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sonya B Norman, PhD; Phone Number: 5198 (858) 552-8585; Email: Sonya.Norman@va.gov
• Study Contact Backup: Name: Kaitlyn Panza, PhD; Phone Number: (858) 552-8585; Email: kaitlyn.panza@va.gov

Study Locations

• United States
  • California
    • San Diego, California, United States, 92161-0002
      • Recruiting
      • VA San Diego Healthcare System, San Diego, CA
      • Principal Investigator: Sonya B. Norman, PhD
      • Contact: Sonya B Norman, PhD; Phone Number: 5198 858-552-8585; Email: Sonya.Norman@va.gov
  • Florida
    • Tampa, Florida, United States, 33612
      • Recruiting
      • James A. Haley Veterans' Hospital, Tampa, FL
      • Contact: Risa Nakase-Richardson, PhD; Phone Number: 8139722000; Email: risa.Nakase-Richardson@va.gov
      • Contact: Brittany Davis, PhD; Phone Number: 813-972-2000; Email: brittany.davis@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trauma Informed Guilt Reduction Therapy (TrIGR); behavioral intervention aimed to reduce trauma-related guilt and shame	Behavioral: Trauma Informed Guilt Reduction Therapy; behavioral intervention aimed to reduce trauma-related guilt and shame; Other Names: TrIGR
Active Comparator: Cognitive Processing Therapy (CPT); behavioral intervention aimed at reducing PTSD symptoms	Behavioral: Cognitive Processing Therapy; behavioral intervention aimed at reducing PTSD symptoms; Other Names: CPT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in Patient Health Questionnaire - 9 (PHQ-9)	change in Patient Health Questionnaire - 9 (PHQ-9) - score ranges 0-27. higher scores are indicative of more severe depressive symptoms. Reduction in scores is considered a positive outcome.	baseline to 28 weeks later
Trauma Related Guilt Inventory (TRGI)	Trauma Related Guilt Inventory (TRGI) - score ranges 0-4. higher scores are indicative of more severe trauma-related guilt. Reduction in scores is considered a positive outcome.	baseline to 28 weeks later
Trauma Related Shame Inventory (TRSI)	Trauma Related Shame Inventory (S) - score ranges 0-72. higher scores are indicative of more severe trauma-related shame. Reduction in scores is considered a positive outcome.	baseline to 28 weeks later

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Sonya B. Norman, PhD, VA San Diego Healthcare System, San Diego, CA

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: March 15, 2023
• First Submitted That Met QC Criteria: March 15, 2023
• First Posted (Actual): March 29, 2023

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: PTSD; trauma; intervention; shame; guilt; moral injury
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: MHBP-003-22S (VA CSR&D); I01CX002584 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: After publication of the primary outcome paper.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No