Clinical trial NCT06296589: Trauma-Informed Guilt Reduction Therapy Compared to Prolonged Exposure
Official title: Clinical Effectiveness and Implementation of Trauma-Informed Guilt Reduction Therapy Compared to Prolonged Exposure (TrIGR)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Lead sponsor: Veterans Medical Research Foundation
Sponsor class: OTHER
Collaborators: name: University of Minnesota
name: Center for Veterans Research and Education
First posted: 2024-03-06
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
timeFrame: baseline and 8-, 16-, and 28 weeks after the first therapy session
Secondary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: baseline and 8-, 16-, and 28 weeks after the first therapy session
measure: Brief Psychosocial Functioning Inventory (B-IPF)
timeFrame: baseline and 8-, 16-, and 28 weeks after the first therapy session
measure: Trauma Related Guilt Inventory Cognitions Scale (TRGI)
timeFrame: baseline and 8-, 16-, and 28 weeks after the first therapy session
measure: Trauma Related Shame Inventory (TRSI)
timeFrame: baseline and 8-, 16-, and 28 weeks after the first therapy session
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Little Rock Veterans Health Care System (LRVHCS)
state: Arkansas
city: New Orleans
country: United States
facility: Southeast Louisiana Veterans Health Care System (SLVHCS)
state: Louisiana
city: Madison
country: United States
facility: William S. Middleton Memorial Hospital
state: Wisconsin
Study officials:
affiliation: University of Minnesota
name: Shannon Kehle-Forbes, PhD
role: PRINCIPAL_INVESTIGATOR
References: