Guilt, Post-traumatic Stress Disorders, Shame
Conditions
Brief 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. A supplemental pilot study added in FY2021 will examine the intervention for pandemic-related guilt events.
Interventions
BEHAVIORALSupportive Care Therapy
Supportive therapy
BEHAVIORALTrauma Informed Guilt Reduction Therapy
Trauma focused therapy
Sponsors
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
Veterans Medical Research Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
188 enrollment goal for primary study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* Moderate or severe cognitive impairment, acute suicidality, current severe substance use disorder, unmanaged psychosis or mania
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trauma Related Guilt Inventory - Guilt Severity | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale - 5 (CAPS-5) | baseline to 8 months | min = 0, max = 80 higher scores = more severe PTSD |
| Change in Patient Health Questionnaire - 9 (PHQ-9) | baseline to 8 months | The PHQ-9 measures severity of depression symptoms. Scores range 0 - 27 higher scores = more severe depression |
| Change in Internalized Shame Scale | baseline to 8-month follow-up | change in Internalized Shame Scale scores range 0 to 120 higher scores = greater internalized shame |
| Change in World Health Organization Quality of Life - Brief | baseline to 8 months | Change in World Health Organization Quality of Life - Brief - score range = 0-100 higher scores = better quality of life |
| Change in Brief Symptom Inventory-18 | baseline to 8 months | Change in Brief Symptom Inventory-18, a measure of depression, anxiety, and somatic symptoms score range = 0 - 72 higher scores = greater distress |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Trauma Informed Guilt Reduction Therapy 6-session psychotherapy intervention
Trauma Informed Guilt Reduction Therapy: Trauma focused therapy | 74 |
| Supportive Care Therapy 6-session psychotherapy intervention
Supportive Care Therapy: Supportive therapy | 71 |
| Total | 145 |
Baseline characteristics
| Characteristic | Trauma Informed Guilt Reduction Therapy | Total | Supportive Care Therapy |
|---|---|---|---|
| Age, Continuous | 38.0 years STANDARD_DEVIATION 7.6 | 39.2 years STANDARD_DEVIATION 8.1 | 40.5 years STANDARD_DEVIATION 8.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 17 Participants | 32 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 49 Participants | 93 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 8 Participants | 20 Participants | 12 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 13 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 13 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 8 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants | 19 Participants | 10 Participants |
| Race (NIH/OMB) White | 49 Participants | 92 Participants | 43 Participants |
| Region of Enrollment United States | 74 participants | 145 participants | 71 participants |
| Sex: Female, Male Female | 5 Participants | 9 Participants | 4 Participants |
| Sex: Female, Male Male | 69 Participants | 136 Participants | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 74 | 0 / 71 |
| other Total, other adverse events | 4 / 74 | 8 / 71 |
| serious Total, serious adverse events | 0 / 74 | 0 / 71 |
Outcome results
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
Time frame: baseline to 8 months
Population: full sample
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Trauma Informed Guilt Reduction Therapy | Trauma Related Guilt Inventory - Guilt Severity | baseline | 2.5 score on a scale |
| Trauma Informed Guilt Reduction Therapy | Trauma Related Guilt Inventory - Guilt Severity | follow-up | 1.6 score on a scale |
| Supportive Care Therapy | Trauma Related Guilt Inventory - Guilt Severity | baseline | 2.5 score on a scale |
| Supportive Care Therapy | Trauma Related Guilt Inventory - Guilt Severity | follow-up | 2.2 score on a scale |
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
Time frame: baseline to 8 months
Population: full sample
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Trauma Informed Guilt Reduction Therapy | Change in Brief Symptom Inventory-18 | baseline | 53.1 score on a scale |
| Trauma Informed Guilt Reduction Therapy | Change in Brief Symptom Inventory-18 | post treatment | 47.3 score on a scale |
| Supportive Care Therapy | Change in Brief Symptom Inventory-18 | baseline | 54.0 score on a scale |
| Supportive Care Therapy | Change in Brief Symptom Inventory-18 | post treatment | 49.0 score on a scale |
Secondary
Change in Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale - 5 (CAPS-5)
min = 0, max = 80 higher scores = more severe PTSD
Time frame: baseline to 8 months
Population: full sample
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Trauma Informed Guilt Reduction Therapy | Change in Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale - 5 (CAPS-5) | baseline | 38.2 score on a scale |
| Trauma Informed Guilt Reduction Therapy | Change in Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale - 5 (CAPS-5) | follow-up | 23.3 score on a scale |
| Supportive Care Therapy | Change in Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale - 5 (CAPS-5) | baseline | 38.6 score on a scale |
| Supportive Care Therapy | Change in Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale - 5 (CAPS-5) | follow-up | 30.9 score on a scale |
Secondary
Change in Internalized Shame Scale
change in Internalized Shame Scale scores range 0 to 120 higher scores = greater internalized shame
Time frame: baseline to 8-month follow-up
Population: full sample
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Trauma Informed Guilt Reduction Therapy | Change in Internalized Shame Scale | baseline | 51.4 score on a scale |
| Trauma Informed Guilt Reduction Therapy | Change in Internalized Shame Scale | follow up | 37.4 score on a scale |
| Supportive Care Therapy | Change in Internalized Shame Scale | follow up | 41.9 score on a scale |
| Supportive Care Therapy | Change in Internalized Shame Scale | baseline | 49.6 score on a scale |
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
Time frame: baseline to 8 months
Population: full sample
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Trauma Informed Guilt Reduction Therapy | Change in Patient Health Questionnaire - 9 (PHQ-9) | baseline | 15.1 score on a scale |
| Trauma Informed Guilt Reduction Therapy | Change in Patient Health Questionnaire - 9 (PHQ-9) | follow up | 9.8 score on a scale |
| Supportive Care Therapy | Change in Patient Health Questionnaire - 9 (PHQ-9) | baseline | 14.4 score on a scale |
| Supportive Care Therapy | Change in Patient Health Questionnaire - 9 (PHQ-9) | follow up | 12.5 score on a scale |
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
Time frame: baseline to 8 months
Population: full sample
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Trauma Informed Guilt Reduction Therapy | Change in World Health Organization Quality of Life - Brief | baseline | 43.7 score on a scale |
| Trauma Informed Guilt Reduction Therapy | Change in World Health Organization Quality of Life - Brief | follow up | 48.3 score on a scale |
| Supportive Care Therapy | Change in World Health Organization Quality of Life - Brief | baseline | 44.5 score on a scale |
| Supportive Care Therapy | Change in World Health Organization Quality of Life - Brief | follow up | 44.4 score on a scale |