GuiltTrIGRNCT02512445

Trauma Informed Guilt Reduction Therapy

A study testing Trauma Informed Guilt Reduction Therapy and Supportive Care Therapy in people with Guilt and Shame, run by Veterans Medical Research Foundation at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The goal of this project is to determine if a 6-session psychotherapy intervention will help Veterans feel less deployment-related guilt and less distress related to their guilt. Half of the participants will receive the guilt focused intervention and half will receive a supportive intervention. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Guilt, Shame, Post-traumatic Stress Disorders
What is being tested?: Trauma Informed Guilt Reduction Therapy and Supportive Care Therapy
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 145 participants
Where: 3 sitesUnited States
Study dates: Oct 2015to Oct 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Participant Served in OEF/OIF/OND, has post-traumatic guilt related to deployment event (for pandemic supplement in 2021, has guilt related to pandemic event)

Who cannot join

Moderate or severe cognitive impairment, acute suicidality, current severe substance use disorder, unmanaged psychosis or mania

Trial locations and contacts

3 sites in 1 country.

United States3 sites

National Center for PTSD
Boston, Massachusetts, 02130
VA Providence Medical Center
Providence, Rhode Island, 02908
VA San Diego Healthcare System
San Diego, California, 92161

Other trials in United States

About this study

Conditions: Guilt, Shame, Post-traumatic Stress Disorders
Being tested: Trauma Informed Guilt Reduction Therapy, Supportive Care 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
Trauma focused therapy
Supportive Care TherapyBehavioural
Supportive therapy

Study groups in NCT02512445
Study group	Role	What they receive
Trauma Informed Guilt Reduction Therapy	Experimental	6-session psychotherapy intervention Receives: Behavioral: Trauma Informed Guilt Reduction Therapy
Supportive Care Therapy	Active comparator	6-session psychotherapy intervention Receives: Behavioral: Supportive Care Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Trauma Related Guilt Inventory - Guilt Severity
Change in Trauma Related Guilt Inventory - Guilt Severity Subscale Min score = 0, max score = 4 (score = mean of all items in subscale) higher scores = greater trauma related guilt severity
Measured: baseline to 8 months

Secondary outcomes (5)

Change in Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale - 5 (CAPS-5)
min = 0, max = 80 higher scores = more severe PTSD
Measured: baseline to 8 months
Change in Patient Health Questionnaire - 9 (PHQ-9)
The PHQ-9 measures severity of depression symptoms. Scores range 0 - 27 higher scores = more severe depression
Measured: baseline to 8 months
Change in Internalized Shame Scale
change in Internalized Shame Scale scores range 0 to 120 higher scores = greater internalized shame
Measured: baseline to 8-month follow-up
Change in World Health Organization Quality of Life - Brief
Change in World Health Organization Quality of Life - Brief - score range = 0-100 higher scores = better quality of life
Measured: baseline to 8 months
Change in Brief Symptom Inventory-18
Change in Brief Symptom Inventory-18, a measure of depression, anxiety, and somatic symptoms score range = 0 - 72 higher scores = greater distress
Measured: baseline to 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2015Oct 2023

First posted30 Jul 2015 (estimated)
Study startOct 2015
Primary completionJun 2023
Study completionOct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for GuiltStudies 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
Model description: 188 enrollment goal for primary study
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 145 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02512445
Sponsor's protocol ID: 09054
Acronym: TrIGR
Status last verified: May 2025
First submitted: 27 Jul 2015
Last updated: 9 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

McCue ML, Capone CC, Wachen JS, Harle KM, Davis BC, Panza KE, Lyons M, Luciano MT, Shea MT, Haller M, Galovski TE, Schnurr PP, Norman SB. Addressing pandemic-related guilt and shame in U.S. military veterans: A pilot randomized controlled trial of trauma-informed guilt reduction and supportive care therapy. Psychol Trauma. 2025 Oct 23:10.1037/tra0002036. doi: 10.1037/tra0002036. Online ahead of print.
PubMed 41129362
Lyons R, Klein AB, Haller M, Panza KE, McCue ML, Saraiya TC, Lang AJ, Schnurr PP, Allard CB, Capone C, Norman SB. Changes in suicidal ideation in a randomized clinical trial for trauma-related guilt in post 9/11 Iraq and Afghanistan veterans. J Psychiatr Res. 2025 Nov;191:463-469. doi: 10.1016/j.jpsychires.2025.09.042. Epub 2025 Oct 1.
PubMed 41046645
Capone C, Norman SB, Haller M, Davis B, Shea MT, Browne K, Lang AJ, Schnurr PP, Golshan S, Afari N, Pittman J, Allard CB, Westendorf L. Trauma Informed Guilt Reduction (TrIGR) therapy for guilt, shame, and moral injury resulting from trauma: Rationale, design, and methodology of a two-site randomized controlled trial. Contemp Clin Trials. 2021 Feb;101:106251. doi: 10.1016/j.cct.2020.106251. Epub 2020 Dec 14.
PubMed 33326878

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Trauma-Informed Guilt Reduction Therapy Compared to Prolonged Exposure
Stress Disorders, Post-Traumatic
Active, not recruiting
Non-Inferiority Trial of TrIGR for PTSD
PTSD
Active, not recruitingObservational study
Factors of Effectiveness in Italian Forensic Treatment
Forensic Psychiatric Patients, Not Guilty by Reason of Insanity (NGRI)
Recruiting
Healthy Recovery After Trauma Study
Stress Disorders, Post-Traumatic, Shame
Not yet recruiting
A Compassionate-focused Intervention for Older People with Bipolar Disorder
Bipolar Disorder I or II

All Guilt trials

Study at a glance

From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Trauma Informed Guilt Reduction Therapy
ClinicalTrials.gov ID: NCT02512445
Acronym / sponsor ID: TrIGR / 09054
Conditions: Guilt, Shame, Post-traumatic Stress Disorders
Study type: Interventional
Recruitment status: Completed
Enrolment: 145 participants (actual)
Lead sponsor: Veterans Medical Research FoundationUniversity, hospital or other
Collaborators: United States Department of Defense, Brown University, Seattle Institute for Biomedical and Clinical Research, White River Junction Veterans Affairs Medical Center, San Diego Veterans Healthcare System, Providence VA Medical Center, National Center for PTSD
Study start: Oct 2015 (actual)
Primary completion: Jun 2023 (actual)
Study completion: Oct 2023 (actual)
First posted: 30 Jul 2015 (estimated)
Results: Posted 9 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: 188 enrollment goal for primary study

Arm	Type	Receives
Trauma Informed Guilt Reduction Therapy	Experimental	Behavioral: Trauma Informed Guilt Reduction Therapy6-session psychotherapy intervention
Supportive Care Therapy	Active comparator	Behavioral: Supportive Care Therapy6-session psychotherapy intervention

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Participant Served in OEF/OIF/OND, has post-traumatic guilt related to deployment event (for pandemic supplement in 2021, has guilt related to pandemic event)

Key exclusion criteria (1 listed)

Moderate or severe cognitive impairment, acute suicidality, current severe substance use disorder, unmanaged psychosis or mania

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 TherapyTrauma focused therapy	Behavioural	Trauma Informed Guilt Reduction Therapy
Supportive Care TherapySupportive therapy	Behavioural	Supportive Care Therapy

Primary outcome

Trauma Related Guilt Inventory - Guilt Severity
Time frame: baseline to 8 months
Change in Trauma Related Guilt Inventory - Guilt Severity Subscale Min score = 0, max score = 4 (score = mean of all items in subscale) higher scores = greater trauma related guilt severity

5 secondary outcomes

Change in Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale - 5 (CAPS-5)
Time frame: baseline to 8 months
Change in Patient Health Questionnaire - 9 (PHQ-9)
Time frame: baseline to 8 months
Change in Internalized Shame Scale
Time frame: baseline to 8-month follow-up
Change in World Health Organization Quality of Life - Brief
Time frame: baseline to 8 months
Change in Brief Symptom Inventory-18
Time frame: baseline to 8 months

Results and safety

Results posted to the registry on 9 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Trauma Informed Guilt Reduction Therapy	74	48
Supportive Care Therapy	71	50

Primary outcome: Trauma Related Guilt Inventory - Guilt Severity

Time frame: baseline to 8 months. Mean (95% Confidence Interval). Unit: score on a scale

Measure	Trauma Informed Guilt Reduction Therapy n = 74	Supportive Care Therapy n = 71
baseline	2.5 (2.3 to 2.7)	2.5 (2.3 to 2.7)
follow-up	1.6 (1.4 to 1.8)	2.2 (1.9 to 2.4)

Population analysed: full sample

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Trauma Informed Guilt Reduction Therapy	0 of 74 (0%)	4 of 74 (5.4%)	1 of 74
Supportive Care Therapy	0 of 71 (0%)	8 of 71 (11.3%)	0 of 71

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41129362McCue ML, Capone CC, Wachen JS, Harle KM, Davis BC, Panza KE, Lyons M, Luciano MT, Shea MT, Haller M, Galovski TE, Schnurr PP, Norman SB. Addressing pandemic-related guilt and shame in U.S. military veterans: A pilot randomized controlled trial of trauma-informed guilt reduction and supportive care therapy. Psychol Trauma. 2025 Oct 23:10.1037/tra0002036. doi: 10.1037/tra0002036. Online ahead of print.
Derived from this study: PubMed 41046645Lyons R, Klein AB, Haller M, Panza KE, McCue ML, Saraiya TC, Lang AJ, Schnurr PP, Allard CB, Capone C, Norman SB. Changes in suicidal ideation in a randomized clinical trial for trauma-related guilt in post 9/11 Iraq and Afghanistan veterans. J Psychiatr Res. 2025 Nov;191:463-469. doi: 10.1016/j.jpsychires.2025.09.042. Epub 2025 Oct 1.
Derived from this study: PubMed 33326878Capone C, Norman SB, Haller M, Davis B, Shea MT, Browne K, Lang AJ, Schnurr PP, Golshan S, Afari N, Pittman J, Allard CB, Westendorf L. Trauma Informed Guilt Reduction (TrIGR) therapy for guilt, shame, and moral injury resulting from trauma: Rationale, design, and methodology of a two-site randomized controlled trial. Contemp Clin Trials. 2021 Feb;101:106251. doi: 10.1016/j.cct.2020.106251. Epub 2020 Dec 14.
Individual participant dataSharing planned: No

Related trials for Guilt

Recruiting
Trauma-Informed Guilt Reduction Therapy Compared to Prolonged Exposure
Stress Disorders, Post-Traumatic
Active, not recruiting
Non-Inferiority Trial of TrIGR for PTSD
PTSD
Active, not recruitingObservational study
Factors of Effectiveness in Italian Forensic Treatment
Forensic Psychiatric Patients, Not Guilty by Reason of Insanity (NGRI)
Recruiting
Healthy Recovery After Trauma Study
Stress Disorders, Post-Traumatic, Shame
Not yet recruiting
A Compassionate-focused Intervention for Older People with Bipolar Disorder
Bipolar Disorder I or II

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

Veterans Medical Research Foundation

Christy Capone, PhD principal investigator

Brown University

3 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 Supportive Care Therapy in people with Guilt and Shame, run by Veterans Medical Research Foundation at 3 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

Yes. Results are posted in the registry (first posted 9 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Trauma Related Guilt Inventory - Guilt Severity (time frame: baseline to 8 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02512445, which also lists 3 linked publications.

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 9 May 2025.