Trauma-Informed Guilt Reduction Therapy Compared to Prolonged Exposure

Stress Disorders, Post-Traumatic Clinical Trial

— PORT  

Official title:

Clinical Effectiveness and Implementation of Trauma-Informed Guilt Reduction Therapy Compared to Prolonged Exposure (TrIGR)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06296589
• Other study ID #: HT94252310861
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: August 2027

Study information

• Verified date: February 2024
• Source: Veterans Medical Research Foundation
• Contact: Sonya Norman, PhD
• Phone: 858-518-8266
• Email: snorman[@]ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 158
• Est. completion date: August 2027
• Est. primary completion date: July 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• Trauma Informed Guilt Reduction Therapy
Behavioral therapy for trauma related guilt and shame
• Prolonged Exposure Therapy
Behavioral exposure therapy for PTSD

Locations

Country	Name	City	State
United States	Little Rock Veterans Health Care System (LRVHCS)	Little Rock	Arkansas
United States	William S. Middleton Memorial Hospital	Madison	Wisconsin
United States	Southeast Louisiana Veterans Health Care System (SLVHCS)	New Orleans	Louisiana

Sponsors (3)

Lead Sponsor	Collaborator
Veterans Medical Research Foundation	Center for Veterans Research and Education, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician Administered PTSD Scale for DSM-5 (CAPS-5)	Measures PTSD symptom severity, score range 0-80, higher scores mean greater symptom severity	baseline and 8-, 16-, and 28 weeks after the first therapy session
Secondary	Patient Health Questionnaire-9 (PHQ-9)	Depression symptom severity, range = 0-27, higher scores mean greater depression symptom severity	baseline and 8-, 16-, and 28 weeks after the first therapy session
Secondary	Brief Psychosocial Functioning Inventory (B-IPF)	Measures severity of impairment in psychosocial functioning, scores = 0-100, higher scores indicate greater impairment	baseline and 8-, 16-, and 28 weeks after the first therapy session
Secondary	Trauma Related Guilt Inventory Cognitions Scale (TRGI)	Measures severity of trauma related guilt cognitions, scores = 0-4, higher scores indicate greater guilt	baseline and 8-, 16-, and 28 weeks after the first therapy session
Secondary	Trauma Related Shame Inventory (TRSI)	Measures severity of trauma related shame, scores = 0-96, higher scores indicate greater shame	baseline and 8-, 16-, and 28 weeks after the first therapy session