Trial Outcomes & Findings for Trauma Informed Guilt Reduction Therapy (NCT NCT02512445)
NCT ID: NCT02512445
Last Updated: 2025-05-09
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
145 participants
Primary outcome timeframe
baseline to 8 months
Results posted on
2025-05-09
Participant Flow
Participant milestones
| Measure |
Trauma Informed Guilt Reduction Therapy
6-session psychotherapy intervention
Trauma Informed Guilt Reduction Therapy: Trauma focused therapy
|
Supportive Care Therapy
6-session psychotherapy intervention
Supportive Care Therapy: Supportive therapy
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
71
|
|
Overall Study
COMPLETED
|
48
|
50
|
|
Overall Study
NOT COMPLETED
|
26
|
21
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trauma Informed Guilt Reduction Therapy
Baseline characteristics by cohort
| Measure |
Trauma Informed Guilt Reduction Therapy
n=74 Participants
6-session psychotherapy intervention
Trauma Informed Guilt Reduction Therapy: Trauma focused therapy
|
Supportive Care Therapy
n=71 Participants
6-session psychotherapy intervention
Supportive Care Therapy: Supportive therapy
|
Total
n=145 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.0 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
40.5 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
39.2 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
74 participants
n=5 Participants
|
71 participants
n=7 Participants
|
145 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to 8 monthsPopulation: full sample
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
Outcome measures
| Measure |
Trauma Informed Guilt Reduction Therapy
n=74 Participants
6-session psychotherapy intervention
Trauma Informed Guilt Reduction Therapy: Trauma focused therapy
|
Supportive Care Therapy
n=71 Participants
6-session psychotherapy intervention
Supportive Care Therapy: Supportive therapy
|
|---|---|---|
|
Trauma Related Guilt Inventory - Guilt Severity
baseline
|
2.5 score on a scale
Interval 2.3 to 2.7
|
2.5 score on a scale
Interval 2.3 to 2.7
|
|
Trauma Related Guilt Inventory - Guilt Severity
follow-up
|
1.6 score on a scale
Interval 1.4 to 1.8
|
2.2 score on a scale
Interval 1.9 to 2.4
|
SECONDARY outcome
Timeframe: baseline to 8 monthsPopulation: full sample
min = 0, max = 80 higher scores = more severe PTSD
Outcome measures
| Measure |
Trauma Informed Guilt Reduction Therapy
n=74 Participants
6-session psychotherapy intervention
Trauma Informed Guilt Reduction Therapy: Trauma focused therapy
|
Supportive Care Therapy
n=71 Participants
6-session psychotherapy intervention
Supportive Care Therapy: Supportive therapy
|
|---|---|---|
|
Change in Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale - 5 (CAPS-5)
baseline
|
38.2 score on a scale
Interval 35.5 to 40.9
|
38.6 score on a scale
Interval 35.9 to 41.4
|
|
Change in Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale - 5 (CAPS-5)
follow-up
|
23.3 score on a scale
Interval 20.2 to 26.4
|
30.9 score on a scale
Interval 27.9 to 34.0
|
SECONDARY outcome
Timeframe: baseline to 8 monthsPopulation: full sample
The PHQ-9 measures severity of depression symptoms. Scores range 0 - 27 higher scores = more severe depression
Outcome measures
| Measure |
Trauma Informed Guilt Reduction Therapy
n=74 Participants
6-session psychotherapy intervention
Trauma Informed Guilt Reduction Therapy: Trauma focused therapy
|
Supportive Care Therapy
n=71 Participants
6-session psychotherapy intervention
Supportive Care Therapy: Supportive therapy
|
|---|---|---|
|
Change in Patient Health Questionnaire - 9 (PHQ-9)
baseline
|
15.1 score on a scale
Interval 13.6 to 16.6
|
14.4 score on a scale
Interval 12.9 to 15.9
|
|
Change in Patient Health Questionnaire - 9 (PHQ-9)
follow up
|
9.8 score on a scale
Interval 8.0 to 11.5
|
12.5 score on a scale
Interval 10.8 to 14.2
|
SECONDARY outcome
Timeframe: baseline to 8-month follow-upPopulation: full sample
change in Internalized Shame Scale scores range 0 to 120 higher scores = greater internalized shame
Outcome measures
| Measure |
Trauma Informed Guilt Reduction Therapy
n=74 Participants
6-session psychotherapy intervention
Trauma Informed Guilt Reduction Therapy: Trauma focused therapy
|
Supportive Care Therapy
n=71 Participants
6-session psychotherapy intervention
Supportive Care Therapy: Supportive therapy
|
|---|---|---|
|
Change in Internalized Shame Scale
baseline
|
51.4 score on a scale
Interval 46.3 to 56.6
|
49.6 score on a scale
Interval 44.3 to 54.8
|
|
Change in Internalized Shame Scale
follow up
|
37.4 score on a scale
Interval 31.6 to 43.1
|
41.9 score on a scale
Interval 36.1 to 47.7
|
SECONDARY outcome
Timeframe: baseline to 8 monthsPopulation: full sample
Change in World Health Organization Quality of Life - Brief - score range = 0-100 higher scores = better quality of life
Outcome measures
| Measure |
Trauma Informed Guilt Reduction Therapy
n=74 Participants
6-session psychotherapy intervention
Trauma Informed Guilt Reduction Therapy: Trauma focused therapy
|
Supportive Care Therapy
n=71 Participants
6-session psychotherapy intervention
Supportive Care Therapy: Supportive therapy
|
|---|---|---|
|
Change in World Health Organization Quality of Life - Brief
baseline
|
43.7 score on a scale
Interval 40.5 to 46.9
|
44.5 score on a scale
Interval 41.3 to 47.8
|
|
Change in World Health Organization Quality of Life - Brief
follow up
|
48.3 score on a scale
Interval 44.6 to 51.9
|
44.4 score on a scale
Interval 40.7 to 48.0
|
SECONDARY outcome
Timeframe: baseline to 8 monthsPopulation: full sample
Change in Brief Symptom Inventory-18, a measure of depression, anxiety, and somatic symptoms score range = 0 - 72 higher scores = greater distress
Outcome measures
| Measure |
Trauma Informed Guilt Reduction Therapy
n=74 Participants
6-session psychotherapy intervention
Trauma Informed Guilt Reduction Therapy: Trauma focused therapy
|
Supportive Care Therapy
n=71 Participants
6-session psychotherapy intervention
Supportive Care Therapy: Supportive therapy
|
|---|---|---|
|
Change in Brief Symptom Inventory-18
post treatment
|
47.3 score on a scale
Interval 44.8 to 49.9
|
49.0 score on a scale
Interval 46.5 to 51.6
|
|
Change in Brief Symptom Inventory-18
baseline
|
53.1 score on a scale
Interval 50.9 to 55.3
|
54.0 score on a scale
Interval 51.7 to 56.3
|
Adverse Events
Trauma Informed Guilt Reduction Therapy
Serious events: 0 serious events
Other events: 4 other events
Deaths: 1 deaths
Supportive Care Therapy
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Trauma Informed Guilt Reduction Therapy
n=74 participants at risk
6-session psychotherapy intervention
Trauma Informed Guilt Reduction Therapy: Trauma focused therapy
|
Supportive Care Therapy
n=71 participants at risk
6-session psychotherapy intervention
Supportive Care Therapy: Supportive therapy
|
|---|---|---|
|
Psychiatric disorders
increased suicidal ideation
|
1.4%
1/74 • Number of events 1 • 6 months
did not differ
|
7.0%
5/71 • Number of events 5 • 6 months
did not differ
|
|
Psychiatric disorders
needed medical detox
|
2.7%
2/74 • Number of events 2 • 6 months
did not differ
|
2.8%
2/71 • Number of events 2 • 6 months
did not differ
|
|
Psychiatric disorders
Arrested
|
1.4%
1/74 • Number of events 1 • 6 months
did not differ
|
1.4%
1/71 • Number of events 1 • 6 months
did not differ
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place