PTSDTrIGR/CPTNCT05789329
Non-Inferiority Trial of TrIGR for PTSD
A study testing Trauma Informed Guilt Reduction Therapy and Cognitive Processing Therapy in people with PTSD, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
Trauma-related guilt is common and impairing among trauma survivors, particularly among Veterans with posttraumatic stress disorder (PTSD). The investigators' work shows that a brief treatment targeting trauma-related guilt, Trauma Informed Guilt Reduction Therapy (TrIGR), can reduce guilt and PTSD and depression… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD
- What is being tested?
- Trauma Informed Guilt Reduction Therapy and Cognitive Processing Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2023to 30 Dec 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;
- meets diagnostic criteria for PTSD or subthreshold 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 Inventor.
- not currently receiving trauma-focused treatment such as CPT or PE; and
- willingness to attend psychotherapy and assessment sessions.
Who cannot join
- Impaired mental status as measured by the Montreal Cognitive Assessment (MoCA) (score < 21) and confirmed by a neuropsychologist,
- Veterans with significant current risk of suicidal/homicidal behavior will be referred to more appropriate treatment;
- 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; or
- inability to read.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, 33612
About this study
Official title: Non-Inferiority Trial of Trauma Informed Guilt Reduction Therapy (TrIGR) for PTSD
Trauma-related guilt is common and impairing among trauma survivors, particularly among Veterans with posttraumatic stress disorder (PTSD). The investigators' work shows that a brief treatment targeting trauma-related guilt, Trauma Informed Guilt Reduction Therapy (TrIGR), can reduce guilt and PTSD and depression symptoms. Whether TrIGR is no less effective than longer, more resource heavy PTSD treatments disseminated by by VA, like cognitive processing therapy (CPT), is the next critical question that this study will seek to answer. 158 Veterans across two VA sites will be randomized to TrIGR or CPT to evaluate changes in PTSD, depression, guilt and shame symptoms across the two treatments.
Read the detailed description
Trauma-related guilt is common and impairing among trauma survivors, particularly among treatment seeking Veterans with posttraumatic stress disorder (PTSD). Although evidence-based trauma-focused PTSD treatments such as Cognitive Processing Therapy (CPT) are effective to treat PTSD and trauma-related guilt, many still experience symptoms or maintain their diagnosis after treatment, and dropout from these generally 12+ session protocols is high. Veterans show lower response and higher dropout than others with PTSD. Delivering protocols that are generally 12 or more sessions challenges the Veterans Affairs (VA) healthcare system given high demand for mental health care. For these reasons, additional and less burdensome approaches are needed. Brief treatment that targets mechanisms that are distressing and associated with multiple problems and disorders may be an understudied but promising way to treat PTSD and other posttraumatic psychopathology. The investigators' work shows that a brief treatment targeting trauma-related guilt and shame, Trauma Informed Guilt Reduction Therapy (TrIGR), can reduce guilt, PTSD, depression, and distress among Veterans and help them reengage with activities they find meaningful. Whether TrIGR is no less effective than longer, more resource heavy evidence-based PTSD treatments disseminated across by VA, like CPT, is the next critical question.
The proposed randomized clinical trial (RCT) will be the first non-inferiority trial of TrIGR and the first to compare TrIGR to a first tier PTSD treatment, specifically CPT. It will also be the first to evaluate TrIGR with Veterans from all eras with guilt from any type of traumas, as the investigators previous work was exclusively with Veterans of the conflicts in Iraq and Afghanistan with deployment-related traumas. 158 Veterans across two VA sites will be randomized to TrIGR or CPT. Exclusion criteria will be minimal so that generalizability will be high. Treatment will be delivered in VA mental health clinics. The primary aim is to evaluate if TrIGR is non-inferior to CPT in reducing PTSD symptom severity among Veterans with PTSD who endorse trauma-related guilt. Secondary aims are to evaluate TrIGR's non-inferiority relative to CPT regarding depression severity. The investigators will explore potential mechanisms of treatment, such as the relationship between change in guilt and shame change in PTSD symptoms. The study is critical to establish whether TrIGR is effective for a much larger group of Veterans and whether it is as effective as longer treatments already available in VA to inform if TrIGR warrants further study and dissemination in VA.
- Conditions
- PTSD
- Being tested
- Trauma Informed Guilt Reduction Therapy, Cognitive Processing Therapy
- Keywords
- PTSD, trauma, moral injury, intervention, guilt, shame
- Medical subject headings
- Stress Disorders, Post-Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma Informed Guilt Reduction TherapyBehavioural
Also called TrIGR
behavioral intervention aimed to reduce trauma-related guilt and shame
Cognitive Processing TherapyBehavioural
Also called CPT
behavioral intervention aimed at reducing PTSD symptoms
| Study group | Role | What they receive |
|---|---|---|
| Trauma Informed Guilt Reduction Therapy (TrIGR) | Experimental | behavioral intervention aimed to reduce trauma-related guilt and shame Receives: Behavioral: Trauma Informed Guilt Reduction Therapy |
| Cognitive Processing Therapy (CPT) | Active comparator | behavioral intervention aimed at reducing PTSD symptoms Receives: Behavioral: Cognitive Processing Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Clinician Administered PTSD Scale - 5 (CAPS-5)
Clinician Administered PTSD Scale - 5 (CAPS-5) - score range 0 - 80; higher scores are indicative of more severe PTSD symptoms. Reduction in scores is considered a positive outcome.
Measured: baseline to 28 weeks later
Secondary outcomes (3)
change in Patient Health Questionnaire - 9 (PHQ-9)
change in Patient Health Questionnaire - 9 (PHQ-9) - score ranges 0-27. higher scores are indicative of more severe depressive symptoms. Reduction in scores is considered a positive outcome.
Measured: baseline to 28 weeks later
Trauma Related Guilt Inventory (TRGI)
Trauma Related Guilt Inventory (TRGI) - score ranges 0-4. higher scores are indicative of more severe trauma-related guilt. Reduction in scores is considered a positive outcome.
Measured: baseline to 28 weeks later
Trauma Related Shame Inventory (TRSI)
Trauma Related Shame Inventory (S) - score ranges 0-72. higher scores are indicative of more severe trauma-related shame. Reduction in scores is considered a positive outcome.
Measured: baseline to 28 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start1 Jun 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Model description
- Participants will be randomly assigned to Trauma Informed Guilt Reduction Therapy (TrIGR) or Cognitive Processing Therapy (CPT).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Sonya B. Norman, PhD, Principal investigator, VA San Diego Healthcare System, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05789329
- Sponsor's protocol ID
- MHBP-003-22S
- Other IDs
- I01CX002584
- Acronym
- TrIGR/CPT
- Status last verified
- Jun 2026
- First submitted
- 15 Mar 2023
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified, anonymized dataset without personal identifiers will be generated and shared with those who request and are granted access (see access criteria). Any HIPAA identifiers, or combinations of variables that could be used for re-identification, will be excluded, as will any proprietary information. The plan does not include any access to individually identifiable or proprietary data. Therefore, this plan will ensure the protection of personal privacy, the confidentiality of individually identifiable private information, and the security of proprietary data and information.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Inferiority Trial of Trauma Informed Guilt Reduction Therapy (TrIGR) for PTSD
- ClinicalTrials.gov ID
- NCT05789329
- Acronym / sponsor ID
- TrIGR/CPT / MHBP-003-22S
- Conditions
- PTSD
- Keywords
- PTSD, trauma, moral injury, intervention, guilt, shame
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 29 Mar 2023 (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.
Trauma-related guilt is common and impairing among trauma survivors, particularly among Veterans with posttraumatic stress disorder (PTSD). The investigators' work shows that a brief treatment targeting trauma-related guilt, Trauma Informed Guilt Reduction Therapy (TrIGR), can reduce guilt and PTSD and depression symptoms. Whether TrIGR is no less effective than longer, more resource heavy PTSD treatments disseminated by by VA, like cognitive processing therapy (CPT), is the next critical question that this study will seek to answer. 158 Veterans across two VA sites will be randomized to TrIGR or CPT to evaluate changes in PTSD, depression, guilt and shame symptoms across the two treatments.
Detailed description
Trauma-related guilt is common and impairing among trauma survivors, particularly among treatment seeking Veterans with posttraumatic stress disorder (PTSD). Although evidence-based trauma-focused PTSD treatments such as Cognitive Processing Therapy (CPT) are effective to treat PTSD and trauma-related guilt, many still experience symptoms or maintain their diagnosis after treatment, and dropout from these generally 12+ session protocols is high. Veterans show lower response and higher dropout than others with PTSD. Delivering protocols that are generally 12 or more sessions challenges the Veterans Affairs (VA) healthcare system given high demand for mental health care. For these reasons, additional and less burdensome approaches are needed. Brief treatment that targets mechanisms that are distressing and associated with multiple problems and disorders may be an understudied but promising way to treat PTSD and other posttraumatic psychopathology. The investigators' work shows that a brief treatment targeting trauma-related guilt and shame, Trauma Informed Guilt Reduction Therapy (TrIGR), can reduce guilt, PTSD, depression, and distress among Veterans and help them reengage with activities they find meaningful. Whether TrIGR is no less effective than longer, more resource heavy evidence-based PTSD treatments disseminated across by VA, like CPT, is the next critical question.
The proposed randomized clinical trial (RCT) will be the first non-inferiority trial of TrIGR and the first to compare TrIGR to a first tier PTSD treatment, specifically CPT. It will also be the first to evaluate TrIGR with Veterans from all eras with guilt from any type of traumas, as the investigators previous work was exclusively with Veterans of the conflicts in Iraq and Afghanistan with deployment-related traumas. 158 Veterans across two VA sites will be randomized to TrIGR or CPT. Exclusion criteria will be minimal so that generalizability will be high. Treatment will be delivered in VA mental health clinics. The primary aim is to evaluate if TrIGR is non-inferior to CPT in reducing PTSD symptom severity among Veterans with PTSD who endorse trauma-related guilt. Secondary aims are to evaluate TrIGR's non-inferiority relative to CPT regarding depression severity. The investigators will explore potential mechanisms of treatment, such as the relationship between change in guilt and shame change in PTSD symptoms. The study is critical to establish whether TrIGR is effective for a much larger group of Veterans and whether it is as effective as longer treatments already available in VA to inform if TrIGR warrants further study and dissemination in VA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to Trauma Informed Guilt Reduction Therapy (TrIGR) or Cognitive Processing Therapy (CPT).
| Arm | Type | Receives |
|---|---|---|
| Trauma Informed Guilt Reduction Therapy (TrIGR) | Experimental | Behavioral: Trauma Informed Guilt Reduction Therapybehavioral intervention aimed to reduce trauma-related guilt and shame |
| Cognitive Processing Therapy (CPT) | Active comparator | Behavioral: Cognitive Processing Therapybehavioral intervention aimed at reducing 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;
- meets diagnostic criteria for PTSD or subthreshold 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 Inventor.
- not currently receiving trauma-focused treatment such as CPT or PE; and
- willingness to attend psychotherapy and assessment sessions.
Key exclusion criteria (6 listed)
- Impaired mental status as measured by the Montreal Cognitive Assessment (MoCA) (score < 21) and confirmed by a neuropsychologist,
- Veterans with significant current risk of suicidal/homicidal behavior will be referred to more appropriate treatment;
- 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; or
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 TherapyAlso: TrIGRbehavioral intervention aimed to reduce trauma-related guilt and shame | Behavioural | Trauma Informed Guilt Reduction Therapy (TrIGR) |
| Cognitive Processing TherapyAlso: CPTbehavioral intervention aimed at reducing PTSD symptoms | Behavioural | Cognitive Processing Therapy (CPT) |
Primary outcome
change in Clinician Administered PTSD Scale - 5 (CAPS-5)
Time frame: baseline to 28 weeks later
Clinician Administered PTSD Scale - 5 (CAPS-5) - score range 0 - 80; higher scores are indicative of more severe PTSD symptoms. Reduction in scores is considered a positive outcome.
3 secondary outcomes
change in Patient Health Questionnaire - 9 (PHQ-9)
Time frame: baseline to 28 weeks later
Trauma Related Guilt Inventory (TRGI)
Time frame: baseline to 28 weeks later
Trauma Related Shame Inventory (TRSI)
Time frame: baseline to 28 weeks later
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 29 Jun 2026.
- Individual participant dataSharing planned: Yes. A de-identified, anonymized dataset without personal identifiers will be generated and shared with those who request and are granted access (see access criteria). Any HIPAA identifiers, or combinations of variables that could be used for re-identification, will be excluded, as will any proprietary information. The plan does not include any access to individually identifiable or proprietary data. Therefore, this plan will ensure the protection of personal privacy, the confidentiality of individually identifiable private information, and the security of proprietary data and information.
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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. This study is not recruiting at the moment.
Sonya B. Norman, PhD principal investigator
VA San Diego Healthcare System, San Diego, CA
2 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 Cognitive Processing Therapy in people with PTSD, run by VA Office of Research and Development at 2 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 6 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: under way, not looking for participants, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in Clinician Administered PTSD Scale - 5 (CAPS-5) (time frame: baseline to 28 weeks later). 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 29 Jun 2026.