Trauma Informed Guilt Reduction Therapy
BehavioralBehavioral therapy for trauma related guilt and shame
NCT Number: NCT06296589
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?
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Little Rock Veterans Health Care System (LRVHCS), Little Rock, Arkansas, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Behavioral therapy for trauma related guilt and shame
Behavioral exposure therapy for PTSD
Time frame: baseline and 8-, 16-, and 28 weeks after the first therapy session
Measures PTSD symptom severity, score range 0-80, higher scores mean greater symptom severity
Time frame: baseline and 8-, 16-, and 28 weeks after the first therapy session
Depression symptom severity, range = 0-27, higher scores mean greater depression symptom severity
Time frame: baseline and 8-, 16-, and 28 weeks after the first therapy session
Measures severity of impairment in psychosocial functioning, scores = 0-100, higher scores indicate greater impairment
Time frame: baseline and 8-, 16-, and 28 weeks after the first therapy session
Measures severity of trauma related guilt cognitions, scores = 0-4, higher scores indicate greater guilt
Time frame: baseline and 8-, 16-, and 28 weeks after the first therapy session
Measures severity of trauma related shame, scores = 0-96, higher scores indicate greater shame
Contact information is provided by the study sponsor or research team.
Kaitlyn Panza, PhD
CONTACT
Sonya Norman, PhD
CONTACT
Veterans Medical Research Foundation
Other
Clinical Effectiveness and Implementation of Trauma-Informed Guilt Reduction Therapy Compared to Prolonged Exposure (TrIGR)
Acronym: PORT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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