Trial Outcomes & Findings for Trauma Survivors Outcomes and Support Study IV (NCT NCT01625416)
NCT ID: NCT01625416
Last Updated: 2017-12-13
Results Overview
The investigators used the PTSD Checklist - Civilian (PCL-C) as a continuous measure. The scoring of the scale ranges from a minimum of 17 to a maximum of 85, with higher scores indicating a worse outcome. No subscales were used.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
121 participants
Primary outcome timeframe
The investigators assessed at baseline, 1-, 3-, and 6-month.
Results posted on
2017-12-13
Participant Flow
Participant milestones
| Measure |
Stepped Care Management
Case management, information technology/mHealth innovations, psychotherapy, and psychopharmacology.: All patients randomized to receive the stepped care management procedures will meet with the trauma support specialist (TSS) prior to discharge from the hospital, who will provide coaching on use of mobile technology for mental health concerns. The TSS will complete follow-up correspondence across the three month time period to assess mental health functioning and use of information technology that addresses medical concerns. Patients who report barriers to mHealth technologies and request additional therapeutic services for mental health concerns assistance will receive evidence-based motivational interviewing and cognitive behavioral intervention procedures that can span up to 3-months.
|
Usual Care
Usual care control patients will be given a list of available community resources and encouraged to proceed using all resources available to them.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
61
|
|
Overall Study
COMPLETED
|
51
|
54
|
|
Overall Study
NOT COMPLETED
|
9
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trauma Survivors Outcomes and Support Study IV
Baseline characteristics by cohort
| Measure |
Stepped Care Management
n=60 Participants
Case management, information technology/mHealth innovations, psychotherapy, and psychopharmacology.: All patients randomized to receive the stepped care management procedures will meet with the trauma support specialist (TSS) prior to discharge from the hospital, who will provide coaching on use of mobile technology for mental health concerns. The TSS will complete follow-up correspondence across the three month time period to assess mental health functioning and use of information technology that addresses medical concerns. Patients who report barriers to mHealth technologies and request additional therapeutic services for mental health concerns assistance will receive evidence-based motivational interviewing and cognitive behavioral intervention procedures that can span up to 3-months.
|
Usual Care
n=61 Participants
Usual care control patients will be given a list of available community resources and encouraged to proceed using all resources available to them.
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
55 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
42.8 years
STANDARD_DEVIATION 14.7 • n=5 Participants
|
43.5 years
STANDARD_DEVIATION 14.8 • n=7 Participants
|
43.2 years
STANDARD_DEVIATION 14.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The investigators assessed at baseline, 1-, 3-, and 6-month.The investigators used the PTSD Checklist - Civilian (PCL-C) as a continuous measure. The scoring of the scale ranges from a minimum of 17 to a maximum of 85, with higher scores indicating a worse outcome. No subscales were used.
Outcome measures
| Measure |
Stepped Care Management
n=60 Participants
Case management, information technology/mHealth innovations, psychotherapy, and psychopharmacology.: All patients randomized to receive the stepped care management procedures will meet with the trauma support specialist (TSS) prior to discharge from the hospital, who will provide coaching on use of mobile technology for mental health concerns. The TSS will complete follow-up correspondence across the three month time period to assess mental health functioning and use of information technology that addresses medical concerns. Patients who report barriers to mHealth technologies and request additional therapeutic services for mental health concerns assistance will receive evidence-based motivational interviewing and cognitive behavioral intervention procedures that can span up to 3-months.
|
Usual Care
n=61 Participants
Usual care control patients will be given a list of available community resources and encouraged to proceed using all resources available to them.
|
|---|---|---|
|
Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury
Baseline
|
47.0 units on a scale
Standard Deviation 10.2
|
47.0 units on a scale
Standard Deviation 10.9
|
|
Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury
1 month
|
43.9 units on a scale
Standard Deviation 16.1
|
43.6 units on a scale
Standard Deviation 15.7
|
|
Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury
3 month
|
41.4 units on a scale
Standard Deviation 16.0
|
45.4 units on a scale
Standard Deviation 16.0
|
|
Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury
6 month
|
41.7 units on a scale
Standard Deviation 16.2
|
47.1 units on a scale
Standard Deviation 16.6
|
PRIMARY outcome
Timeframe: The investigators assessed at baseline, 1-, 3-, and 6-month.The investigators used the Patient Health Questionnaire (PHQ-9) as a continuous measure, with scores ranging from 1 to 27. Higher scores represent a worse outcome. No subscales were used.
Outcome measures
| Measure |
Stepped Care Management
n=60 Participants
Case management, information technology/mHealth innovations, psychotherapy, and psychopharmacology.: All patients randomized to receive the stepped care management procedures will meet with the trauma support specialist (TSS) prior to discharge from the hospital, who will provide coaching on use of mobile technology for mental health concerns. The TSS will complete follow-up correspondence across the three month time period to assess mental health functioning and use of information technology that addresses medical concerns. Patients who report barriers to mHealth technologies and request additional therapeutic services for mental health concerns assistance will receive evidence-based motivational interviewing and cognitive behavioral intervention procedures that can span up to 3-months.
|
Usual Care
n=61 Participants
Usual care control patients will be given a list of available community resources and encouraged to proceed using all resources available to them.
|
|---|---|---|
|
Change in Depression Symptoms Over the Course of the Six Months After Injury
Baseline
|
14.3 units on a scale
Standard Deviation 5.7
|
15.0 units on a scale
Standard Deviation 5.0
|
|
Change in Depression Symptoms Over the Course of the Six Months After Injury
1 month
|
13.2 units on a scale
Standard Deviation 6.3
|
13.8 units on a scale
Standard Deviation 6.1
|
|
Change in Depression Symptoms Over the Course of the Six Months After Injury
3 month
|
12.5 units on a scale
Standard Deviation 6.4
|
14.1 units on a scale
Standard Deviation 7.4
|
|
Change in Depression Symptoms Over the Course of the Six Months After Injury
6 month
|
12.5 units on a scale
Standard Deviation 7.2
|
14.4 units on a scale
Standard Deviation 7.2
|
PRIMARY outcome
Timeframe: Baseline to 6 monthsThe investigators used laptop tracking software to determine technology usage.
Outcome measures
| Measure |
Stepped Care Management
n=60 Participants
Case management, information technology/mHealth innovations, psychotherapy, and psychopharmacology.: All patients randomized to receive the stepped care management procedures will meet with the trauma support specialist (TSS) prior to discharge from the hospital, who will provide coaching on use of mobile technology for mental health concerns. The TSS will complete follow-up correspondence across the three month time period to assess mental health functioning and use of information technology that addresses medical concerns. Patients who report barriers to mHealth technologies and request additional therapeutic services for mental health concerns assistance will receive evidence-based motivational interviewing and cognitive behavioral intervention procedures that can span up to 3-months.
|
Usual Care
n=61 Participants
Usual care control patients will be given a list of available community resources and encouraged to proceed using all resources available to them.
|
|---|---|---|
|
Technology Use
|
24.76 minutes
Standard Deviation 42.51
|
16.05 minutes
Standard Deviation 26.82
|
PRIMARY outcome
Timeframe: Baseline to 6 monthsThe investigators used laptop tracking software to assess number of patients using laptops.
Outcome measures
| Measure |
Stepped Care Management
n=60 Participants
Case management, information technology/mHealth innovations, psychotherapy, and psychopharmacology.: All patients randomized to receive the stepped care management procedures will meet with the trauma support specialist (TSS) prior to discharge from the hospital, who will provide coaching on use of mobile technology for mental health concerns. The TSS will complete follow-up correspondence across the three month time period to assess mental health functioning and use of information technology that addresses medical concerns. Patients who report barriers to mHealth technologies and request additional therapeutic services for mental health concerns assistance will receive evidence-based motivational interviewing and cognitive behavioral intervention procedures that can span up to 3-months.
|
Usual Care
n=61 Participants
Usual care control patients will be given a list of available community resources and encouraged to proceed using all resources available to them.
|
|---|---|---|
|
Feasibility/Acceptability of Intervention
|
37 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: The investigators assessed at baseline, 1-, 3-, and 6-month.The investigators used 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. No sub scales were used.
Outcome measures
| Measure |
Stepped Care Management
n=60 Participants
Case management, information technology/mHealth innovations, psychotherapy, and psychopharmacology.: All patients randomized to receive the stepped care management procedures will meet with the trauma support specialist (TSS) prior to discharge from the hospital, who will provide coaching on use of mobile technology for mental health concerns. The TSS will complete follow-up correspondence across the three month time period to assess mental health functioning and use of information technology that addresses medical concerns. Patients who report barriers to mHealth technologies and request additional therapeutic services for mental health concerns assistance will receive evidence-based motivational interviewing and cognitive behavioral intervention procedures that can span up to 3-months.
|
Usual Care
n=61 Participants
Usual care control patients will be given a list of available community resources and encouraged to proceed using all resources available to them.
|
|---|---|---|
|
Alcohol Use Problems
Baseline
|
4.5 units on a scale
Standard Deviation 3.4
|
4.2 units on a scale
Standard Deviation 3.9
|
|
Alcohol Use Problems
1 month
|
1.5 units on a scale
Standard Deviation 2.7
|
1.0 units on a scale
Standard Deviation 2.3
|
|
Alcohol Use Problems
3 month
|
2.4 units on a scale
Standard Deviation 3.1
|
1.9 units on a scale
Standard Deviation 3.1
|
|
Alcohol Use Problems
6 month
|
2.7 units on a scale
Standard Deviation 3.0
|
2.1 units on a scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: The investigators assessed at baseline, 1-, 3-, and 6-month.The investigators used 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. No other subscales will be used.
Outcome measures
| Measure |
Stepped Care Management
n=60 Participants
Case management, information technology/mHealth innovations, psychotherapy, and psychopharmacology.: All patients randomized to receive the stepped care management procedures will meet with the trauma support specialist (TSS) prior to discharge from the hospital, who will provide coaching on use of mobile technology for mental health concerns. The TSS will complete follow-up correspondence across the three month time period to assess mental health functioning and use of information technology that addresses medical concerns. Patients who report barriers to mHealth technologies and request additional therapeutic services for mental health concerns assistance will receive evidence-based motivational interviewing and cognitive behavioral intervention procedures that can span up to 3-months.
|
Usual Care
n=61 Participants
Usual care control patients will be given a list of available community resources and encouraged to proceed using all resources available to them.
|
|---|---|---|
|
Physical Functioning
Baseline
|
47.3 units on a scale
Standard Deviation 13.0
|
42.8 units on a scale
Standard Deviation 14.0
|
|
Physical Functioning
1 month
|
27.9 units on a scale
Standard Deviation 11.8
|
27.4 units on a scale
Standard Deviation 11.6
|
|
Physical Functioning
3 month
|
35.2 units on a scale
Standard Deviation 13.1
|
33.6 units on a scale
Standard Deviation 13.4
|
|
Physical Functioning
6 month
|
36.9 units on a scale
Standard Deviation 11.5
|
34.6 units on a scale
Standard Deviation 12.3
|
Adverse Events
Stepped Care Management
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Stepped Care Management
n=60 participants at risk
Case management, information technology/mHealth innovations, psychotherapy, and psychopharmacology.: All patients randomized to receive the stepped care management procedures will meet with the trauma support specialist (TSS) prior to discharge from the hospital, who will provide coaching on use of mobile technology for mental health concerns. The TSS will complete follow-up correspondence across the three month time period to assess mental health functioning and use of information technology that addresses medical concerns. Patients who report barriers to mHealth technologies and request additional therapeutic services for mental health concerns assistance will receive evidence-based motivational interviewing and cognitive behavioral intervention procedures that can span up to 3-months.
|
Usual Care
n=61 participants at risk
Usual care control patients will be given a list of available community resources and encouraged to proceed using all resources available to them.
|
|---|---|---|
|
Psychiatric disorders
Suicide ideation
|
51.7%
31/60 • 6 months
|
59.0%
36/61 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place