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RECRUITINGINTERVENTIONAL

Non-Inferiority Trial of TrIGR for PTSD

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

BEHAVIORAL

Trauma Informed Guilt Reduction Therapy

behavioral intervention aimed to reduce trauma-related guilt and shame

BEHAVIORAL

Cognitive Processing Therapy

behavioral intervention aimed at reducing PTSD symptoms

Locations (2)

VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, United States