Trial Outcomes & Findings for A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity Pilot (NCT NCT02335125)
NCT ID: NCT02335125
Last Updated: 2020-09-11
Results Overview
The investigators will use the PTSD Checklist - Civilian (PCL-C). The scoring of the scale ranges from a minimum of 17 to a maximum of 85, with higher scores indicating a worse outcome. The measure can also provide a rating of symptoms consistent with a diagnosis of PTSD.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Baseline and 1-month
Results posted on
2020-09-11
Participant Flow
Participant milestones
| Measure |
Intervention
The intervention aims to prevent the development of chronic PTSD and depressive symptoms, alcohol use problems, and enduring physical disability in survivors of both TBI and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, medication, and psychotherapy elements.
Motivational Interviewing
Cognitive Behavioral Therapy Elements
Psychotropic Drugs
Care Management
|
Usual Care
Only standard care practices will be administered to this arm.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity Pilot
Baseline characteristics by cohort
| Measure |
Intervention
n=20 Participants
The intervention aims to prevent the development of chronic PTSD and depressive symptoms, alcohol use problems, and enduring physical disability in survivors of both TBI and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, medication, and psychotherapy elements.
Motivational Interviewing
Cognitive Behavioral Therapy Elements
Psychotropic Drugs
Care Management
|
Usual Care
n=20 Participants
Only standard care practices will be administered to this arm.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Age, Continuous
|
43.8 years
STANDARD_DEVIATION 18.1 • n=93 Participants
|
48.4 years
STANDARD_DEVIATION 18.9 • n=4 Participants
|
46.0 years
STANDARD_DEVIATION 18.4 • n=27 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
37 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline and 1-monthThe investigators will use the PTSD Checklist - Civilian (PCL-C). The scoring of the scale ranges from a minimum of 17 to a maximum of 85, with higher scores indicating a worse outcome. The measure can also provide a rating of symptoms consistent with a diagnosis of PTSD.
Outcome measures
| Measure |
Intervention
n=20 Participants
The intervention aims to prevent the development of chronic PTSD and depressive symptoms, alcohol use problems, and enduring physical disability in survivors of both TBI and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, medication, and psychotherapy elements.
Motivational Interviewing
Cognitive Behavioral Therapy Elements
Psychotropic Drugs
Care Management
|
Usual Care
n=20 Participants
Only standard care practices will be administered to this arm.
|
|---|---|---|
|
Change From Baseline PTSD Checklist Civilian (PCL-C) at 1 Month
|
1.30 score on a scale
Interval -4.81 to 7.42
|
5.04 score on a scale
Interval -1.07 to 11.15
|
PRIMARY outcome
Timeframe: Baseline and 1-monthThe investigators will use the Alcohol Use Disorders Identification Test (AUDIT) as a continuous measure. The 10-item scale score ranges from 0-40, with higher values indicating a worse outcome.
Outcome measures
| Measure |
Intervention
n=20 Participants
The intervention aims to prevent the development of chronic PTSD and depressive symptoms, alcohol use problems, and enduring physical disability in survivors of both TBI and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, medication, and psychotherapy elements.
Motivational Interviewing
Cognitive Behavioral Therapy Elements
Psychotropic Drugs
Care Management
|
Usual Care
n=20 Participants
Only standard care practices will be administered to this arm.
|
|---|---|---|
|
Change From Baseline Alcohol Use Disorders Identification at 1 Month
|
-1.36 score on a scale
Interval -3.38 to 0.66
|
-2.31 score on a scale
Interval -4.38 to -0.25
|
PRIMARY outcome
Timeframe: Baseline and 1-monthThe investigators will use the Patient Health Questionnaire 9-item Depression Scale (PHQ-9). The scoring of the scale ranges from a minimum of 0 to a maximum of 27, with higher scores indicating a worse outcome.
Outcome measures
| Measure |
Intervention
n=20 Participants
The intervention aims to prevent the development of chronic PTSD and depressive symptoms, alcohol use problems, and enduring physical disability in survivors of both TBI and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, medication, and psychotherapy elements.
Motivational Interviewing
Cognitive Behavioral Therapy Elements
Psychotropic Drugs
Care Management
|
Usual Care
n=20 Participants
Only standard care practices will be administered to this arm.
|
|---|---|---|
|
Change From Patient Health Questionnaire 9 Item Depression Scale at 1 Month
|
1.27 score on a scale
Interval -1.2 to 3.74
|
0.28 score on a scale
Interval -2.25 to 2.82
|
SECONDARY outcome
Timeframe: Baseline and 1-monthThe investigators will use the Medical Outcomes Study Short Form healthy survey (MOS SF-12/36) physical components summary to assess physical function. The minimum and maximum scores are 0-100 with higher scores representing a better outcome.
Outcome measures
| Measure |
Intervention
n=20 Participants
The intervention aims to prevent the development of chronic PTSD and depressive symptoms, alcohol use problems, and enduring physical disability in survivors of both TBI and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, medication, and psychotherapy elements.
Motivational Interviewing
Cognitive Behavioral Therapy Elements
Psychotropic Drugs
Care Management
|
Usual Care
n=20 Participants
Only standard care practices will be administered to this arm.
|
|---|---|---|
|
Change in Functional Status
Baseline
|
48.2 score on a scale
Standard Deviation 12.2
|
46.5 score on a scale
Standard Deviation 12.1
|
|
Change in Functional Status
1 Month
|
30.1 score on a scale
Standard Deviation 13.6
|
33.0 score on a scale
Standard Deviation 9.1
|
SECONDARY outcome
Timeframe: Baseline and 1-monthItem 9 of the Patient Health Questionnaire 9-item (PHQ-9) scale assesses suicidal ideation. It is scored from 0 to 3, with a score of 1 or greater indicating a patient has suicidal ideation. Participants with a PHQ-9 item 9 score of greater than or equal to 1 are reported for this outcome.
Outcome measures
| Measure |
Intervention
n=20 Participants
The intervention aims to prevent the development of chronic PTSD and depressive symptoms, alcohol use problems, and enduring physical disability in survivors of both TBI and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, medication, and psychotherapy elements.
Motivational Interviewing
Cognitive Behavioral Therapy Elements
Psychotropic Drugs
Care Management
|
Usual Care
n=20 Participants
Only standard care practices will be administered to this arm.
|
|---|---|---|
|
Patient Health Questionnaire Item 9 Suicide Question
Baseline
|
3 Participants
|
2 Participants
|
|
Patient Health Questionnaire Item 9 Suicide Question
1 Month
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline and 1-monthSingle items that assess drug use across multiple substances (e.g., Cocaine, Prescription Opiates). Single item self-report dichotomized as none versus at least monthly use.
Outcome measures
| Measure |
Intervention
n=20 Participants
The intervention aims to prevent the development of chronic PTSD and depressive symptoms, alcohol use problems, and enduring physical disability in survivors of both TBI and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, medication, and psychotherapy elements.
Motivational Interviewing
Cognitive Behavioral Therapy Elements
Psychotropic Drugs
Care Management
|
Usual Care
n=20 Participants
Only standard care practices will be administered to this arm.
|
|---|---|---|
|
Number of Participants Endorsing a Single Item That Assesses Drug Use
Baseline
|
12 Participants
|
10 Participants
|
|
Number of Participants Endorsing a Single Item That Assesses Drug Use
1 Month
|
15 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Baseline and 1-monthThe investigators will use the National Study on the Costs and Outcomes of Trauma (NSCOT) Cognitive Screen, a 4 - Item Traumatic Brain Injury / Post-concussive Symptom Screen. The scoring of the scale ranges from a minimum of 4 to a maximum of 20, with lower scores indicating a worse outcome.
Outcome measures
| Measure |
Intervention
n=20 Participants
The intervention aims to prevent the development of chronic PTSD and depressive symptoms, alcohol use problems, and enduring physical disability in survivors of both TBI and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, medication, and psychotherapy elements.
Motivational Interviewing
Cognitive Behavioral Therapy Elements
Psychotropic Drugs
Care Management
|
Usual Care
n=20 Participants
Only standard care practices will be administered to this arm.
|
|---|---|---|
|
Cognitive Impairment Scale
Baseline
|
16.3 score on a scale
Standard Deviation 3.3
|
16.9 score on a scale
Standard Deviation 3.4
|
|
Cognitive Impairment Scale
1 Month
|
16.3 score on a scale
Standard Deviation 4.1
|
15.9 score on a scale
Standard Deviation 4.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineModerating Variable
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineModerating Variable
Outcome measures
Outcome data not reported
Adverse Events
Intervention
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intervention
n=20 participants at risk
The intervention aims to prevent the development of chronic PTSD and depressive symptoms, alcohol use problems, and enduring physical disability in survivors of both TBI and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, medication, and psychotherapy elements.
Motivational Interviewing
Cognitive Behavioral Therapy Elements
Psychotropic Drugs
Care Management
|
Usual Care
n=20 participants at risk
Only standard care practices will be administered to this arm.
|
|---|---|---|
|
Surgical and medical procedures
Surgical complication unrelated to study participation which resulted in death
|
5.0%
1/20
|
0.00%
0/20
|
Other adverse events
Adverse event data not reported
Additional Information
Douglas Zatzick, MD
University of Washington Harborview Medical Center
Phone: (206) 744-6701
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place