Trauma-Informed Guilt Reduction Therapy Compared to Prolonged Exposure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Trauma Informed Guilt Reduction Therapy, Prolonged Exposure Therapy.
- Who it may be relevant to
- Registry conditions: Stress Disorders, Post-Traumatic. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical Effectiveness and Implementation of Trauma-Informed Guilt Reduction Therapy Compared to Prolonged Exposure (TrIGR)
Overview
The goal of this clinical trial is to learn if receiving Trauma-Informed Guilt Reduction (TrIGR) Therapy is as effective as receiving Prolonged Exposure Therapy among veterans with PTSD and trauma related guilt. The main questions it aims to answer are: Will TrIGR be comparable to PE in terms of PTSD symptom reduction? Will it TrIGR be comparable to PE in improving functioning and reducing depression symptoms? Will it be superior in improving trauma-related guilt and shame?
Detailed description
Trauma-related guilt is common and impairing among trauma survivors. Guilt is positively associated with severity of PTSD and depression symptoms, poorer psychosocial functioning and suicide risk. Although existing evidence-based trauma-focused PTSD treatments such as Prolonged Exposure (PE) are effective in treating PTSD and trauma-related guilt, many still experience symptoms or maintain their diagnosis after treatment. Preliminary research shows that a brief treatment targeting trauma-related and moral injury-related guilt and shame, Trauma Informed Guilt Reduction Therapy (TrIGR), can reduce guilt, PTSD, depression, and distress among Veterans and help them reengage with meaningful activities. Whether TrIGR is comparably effective to longer, more resource heavy evidence-based PTSD treatments disseminated across DoD and VA, like PE, is a critical question.
The proposed randomized clinical trial aims to determine if TrIGR is non-inferior to a first tier PTSD treatment, PE. Hypotheses are that 6 sessions of TrIGR will be non-inferior to 12 sessions of PE in reducing PTSD symptom severity among Veterans with PTSD who endorse trauma-related guilt. Secondary aims are to evaluate the hypotheses that TrIGR will be non-inferiority relative to PE in improving psychosocial functioning and depression symptoms and superior in reducing trauma-related guilt and shame. The study will also explore treatment differences in change in suicidal ideation and dropout.
Participants will be recruited from mental health clinics across three VAs. 158 Veterans who served since 9/11 and with PTSD and guilt from any type of trauma will be included. TrIGR will be administered over 6 weekly sessions (60-minutes each) and PE will be administered over 12 weekly sessions (90 minutes each). Blind assessors will evaluate participants at baseline and 8-, 16-, and 28 weeks after the first therapy session. Inclusion and exclusion criteria are minimized so that generalizability will be high.
Interventions
- Behavioral Trauma Informed Guilt Reduction Therapy
Behavioral therapy for trauma related guilt and shame - Behavioral Prolonged Exposure Therapy
Behavioral exposure therapy for PTSD
Primary outcome measures
- Clinician Administered PTSD Scale for DSM-5 (CAPS-5) [Time frame: baseline and 8-, 16-, and 28 weeks after the first therapy session]
Secondary outcome measures (4)
- Patient Health Questionnaire-9 (PHQ-9) [Time frame: baseline and 8-, 16-, and 28 weeks after the first therapy session]
- Brief Psychosocial Functioning Inventory (B-IPF) [Time frame: baseline and 8-, 16-, and 28 weeks after the first therapy session]
- Trauma Related Guilt Inventory Cognitions Scale (TRGI) [Time frame: baseline and 8-, 16-, and 28 weeks after the first therapy session]
- Trauma Related Shame Inventory (TRSI) [Time frame: baseline and 8-, 16-, and 28 weeks after the first therapy session]
Eligibility criteria
Inclusion criteria
- U.S. Veterans age 18 or older who served in the military since the start of Operation Enduring Freedom/Operation Iraqi Freedom; OEF/OIF)
- meets diagnostic criteria for 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 Inventory
- not currently receiving trauma-focused treatment such as PE or CPT
- willingness to attend psychotherapy and assessment sessions
Exclusion criteria
- current risk of suicidal/homicidal behavior that requires immediate intervention
- 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
- inability to read
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 3 centers
- Little Rock Veterans Health Care System (LRVHCS) — Little Rock
- Southeast Louisiana Veterans Health Care System (SLVHCS) — New Orleans
- William S. Middleton Memorial Hospital — Madison
Identifiers
NCT: NCT06296589 · HT94252310861