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| Name | Class |
|---|---|
| United States Department of Defense | FED |
| Brown University | OTHER |
| Seattle Institute for Biomedical and Clinical Research | OTHER |
| White River Junction Veterans Affairs Medical Center |
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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. A supplemental pilot study added in FY2021 will examine the intervention for pandemic-related guilt events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trauma Informed Guilt Reduction Therapy | Experimental | 6-session psychotherapy intervention |
|
| Supportive Care Therapy | Active Comparator | 6-session psychotherapy intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trauma Informed Guilt Reduction Therapy | Behavioral | Trauma focused therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline to 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale - 5 (CAPS-5) | min = 0, max = 80 higher scores = more severe PTSD | baseline to 8 months |
| Change in Patient Health Questionnaire - 9 (PHQ-9) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sonya B. Norman, PhD | Veterans Medical Research Foundation | Principal Investigator |
| Christy Capone, PhD | Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA San Diego Healthcare System | San Diego | California | 92161 | United States | ||
| National Center for PTSD |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41129362 | Derived | 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. | |
| 33326878 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Trauma Informed Guilt Reduction Therapy | 6-session psychotherapy intervention Trauma Informed Guilt Reduction Therapy: Trauma focused therapy |
| FG001 | Supportive Care Therapy | 6-session psychotherapy intervention Supportive Care Therapy: Supportive therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Trauma Informed Guilt Reduction Therapy | 6-session psychotherapy intervention Trauma Informed Guilt Reduction Therapy: Trauma focused therapy |
| BG001 | Supportive Care Therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | full sample | Posted | Mean | 95% Confidence Interval | score on a scale | baseline to 8 months |
|
6 months
did not differ
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Trauma Informed Guilt Reduction Therapy | 6-session psychotherapy intervention Trauma Informed Guilt Reduction Therapy: Trauma focused therapy |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| increased suicidal ideation | Psychiatric disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sonya Norman | UCSD | 858-518-8266 | snorman@ucsd.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 14, 2014 | May 7, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| FED |
| San Diego Veterans Healthcare System | FED |
| Providence VA Medical Center | FED |
| National Center for PTSD | FED |
188 enrollment goal for primary study
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| Supportive Care Therapy | Behavioral | Supportive therapy |
|
The PHQ-9 measures severity of depression symptoms. Scores range 0 - 27 higher scores = more severe depression
| baseline to 8 months |
| Change in Internalized Shame Scale | change in Internalized Shame Scale scores range 0 to 120 higher scores = greater internalized shame | 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 | 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 | baseline to 8 months |
| Boston |
| Massachusetts |
| 02130 |
| United States |
| VA Providence Medical Center | Providence | Rhode Island | 02908 | United States |
| Derived |
| 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. |
6-session psychotherapy intervention
Supportive Care Therapy: Supportive therapy
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Change in Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale - 5 (CAPS-5) | min = 0, max = 80 higher scores = more severe PTSD | full sample | Posted | Number | 95% Confidence Interval | score on a scale | baseline to 8 months |
|
|
|
| Secondary | 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 | full sample | Posted | Mean | 95% Confidence Interval | score on a scale | baseline to 8 months |
|
|
|
| Secondary | Change in Internalized Shame Scale | change in Internalized Shame Scale scores range 0 to 120 higher scores = greater internalized shame | full sample | Posted | Mean | 95% Confidence Interval | score on a scale | baseline to 8-month follow-up |
|
|
|
| Secondary | 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 | full sample | Posted | Mean | 95% Confidence Interval | score on a scale | baseline to 8 months |
|
|
|
| Secondary | 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 | full sample | Posted | Mean | 95% Confidence Interval | score on a scale | baseline to 8 months |
|
|
|
| 1 |
| 74 |
| 0 |
| 74 |
| 4 |
| 74 |
| EG001 | Supportive Care Therapy | 6-session psychotherapy intervention Supportive Care Therapy: Supportive therapy | 0 | 71 | 0 | 71 | 8 | 71 |
| needed medical detox | Psychiatric disorders | Non-systematic Assessment |
|
| Arrested | Psychiatric disorders | Non-systematic Assessment |
|
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