Stress Disorders, Post-TraumaticPORTNCT06296589
Trauma-Informed Guilt Reduction Therapy Compared to Prolonged Exposure
A study testing Trauma Informed Guilt Reduction Therapy and Prolonged Exposure Therapy in people with Stress Disorders, Post-Traumatic, run by Veterans Medical Research Foundation at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- Trauma Informed Guilt Reduction Therapy and Prolonged Exposure Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Dec 2024to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Little Rock Veterans Health Care System (LRVHCS)
Little Rock, Arkansas, 72205
Brandon Griffin, (501) 257-1000, Brandon.Griffin2@va.gov
- Recruiting
William S. Middleton Memorial Hospital
Madison, Wisconsin, 53705
Michael Messina, PhD, 608-284-6302, Michael.Messina2@va.gov
- Recruiting
Southeast Louisiana Veterans Health Care System (SLVHCS)
New Orleans, Louisiana, 70119
Laurel Franklin, PhD, 800-935-8387, Laurel.Franklin@va.gov
- Recruiting
VA San Diego
San Diego, California, 92161
Kaitlyn Panza, 858-552-8585, kaitlyn.panza@va.gov
Kaitlyn Panza, PhD
About this study
Official title: Clinical Effectiveness and Implementation of Trauma-Informed Guilt Reduction Therapy Compared to Prolonged Exposure (TrIGR)
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?
Read the 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.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- Trauma Informed Guilt Reduction Therapy, Prolonged Exposure Therapy
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma Informed Guilt Reduction TherapyBehavioural
Behavioral therapy for trauma related guilt and shame
Prolonged Exposure TherapyBehavioural
Behavioral exposure therapy for PTSD
| Study group | Role | What they receive |
|---|---|---|
| trauma Informed Guilt Reduction Therapy | Experimental | 6 session behavioral intervention focused on trauma-related guilt, shame, and moral injury Receives: Behavioral: Trauma Informed Guilt Reduction Therapy |
| Prolonged Exposure Therapy | Active comparator | 12 session behavioral intervention focused on PTSD symptoms Receives: Behavioral: Prolonged Exposure Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Measures PTSD symptom severity, score range 0-80, higher scores mean greater symptom severity
Measured: baseline and 8-, 16-, and 28 weeks after the first therapy session
Secondary outcomes (4)
Patient Health Questionnaire-9 (PHQ-9)
Depression symptom severity, range = 0-27, higher scores mean greater depression symptom severity
Measured: baseline and 8-, 16-, and 28 weeks after the first therapy session
Brief Psychosocial Functioning Inventory (B-IPF)
Measures severity of impairment in psychosocial functioning, scores = 0-100, higher scores indicate greater impairment
Measured: baseline and 8-, 16-, and 28 weeks after the first therapy session
Trauma Related Guilt Inventory Cognitions Scale (TRGI)
Measures severity of trauma related guilt cognitions, scores = 0-4, higher scores indicate greater guilt
Measured: baseline and 8-, 16-, and 28 weeks after the first therapy session
Trauma Related Shame Inventory (TRSI)
Measures severity of trauma related shame, scores = 0-96, higher scores indicate greater shame
Measured: baseline and 8-, 16-, and 28 weeks after the first therapy session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start1 Dec 2024
- Primary completionJul 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Veterans Medical Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota, Center for Veterans Research and Education
- Responsible party
- Sponsor
- Investigators
- Shannon Kehle-Forbes, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296589
- Sponsor's protocol ID
- HT94252310861
- Acronym
- PORT
- Status last verified
- Aug 2026
- First submitted
- 28 Feb 2024
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will share data with Strong Star Repository.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness and Implementation of Trauma-Informed Guilt Reduction Therapy Compared to Prolonged Exposure (TrIGR)
- ClinicalTrials.gov ID
- NCT06296589
- Acronym / sponsor ID
- PORT / HT94252310861
- Conditions
- Stress Disorders, Post-Traumatic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Veterans Medical Research FoundationUniversity, hospital or other
- Collaborators
- University of Minnesota, Center for Veterans Research and Education
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| trauma Informed Guilt Reduction Therapy | Experimental | Behavioral: Trauma Informed Guilt Reduction Therapy6 session behavioral intervention focused on trauma-related guilt, shame, and moral injury |
| Prolonged Exposure Therapy | Active comparator | Behavioral: Prolonged Exposure Therapy12 session behavioral intervention focused on PTSD symptoms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trauma Informed Guilt Reduction TherapyBehavioral therapy for trauma related guilt and shame | Behavioural | trauma Informed Guilt Reduction Therapy |
| Prolonged Exposure TherapyBehavioral exposure therapy for PTSD | Behavioural | Prolonged Exposure Therapy |
Primary outcome
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: Yes. Will share data with Strong Star Repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shannon Kehle-Forbes, PhD principal investigator
University of Minnesota
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trauma Informed Guilt Reduction Therapy and Prolonged Exposure Therapy in people with Stress Disorders, Post-Traumatic, run by Veterans Medical Research Foundation at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sonya Norman, PhD (858-518-8266, snorman@ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician Administered PTSD Scale for DSM-5 (CAPS-5) (time frame: baseline and 8-, 16-, and 28 weeks after the first therapy session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.