TSOS IV: Trauma Survivors Outcomes and Support Study IV

• Sponsor: University of Washington (Other)
• Overall Status: Completed
• CT.gov ID: NCT01625416
• Collaborator: National Institute of Mental Health (NIMH) (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
• Enrollment: 121
• Location: 1
• Arms: 2
• Actual Duration (Months): 39
• Patients Per Site Per Month: 3.1

Study Details

Study Description

Brief Summary

After traumatic injuries some people have difficulty returning to the routine of their everyday activities and may experience physical and emotional pain. The purpose of this study is to identify new ways of providing support for physically injured trauma survivors. All study procedures are designed to work around patient needs and be as flexible as possible in order to best fit into patients' post-injury recovery.

Patients who are eligible for the study are randomly assigned to receive care as usual, or the "new method of treatment," with the study Trauma Support Specialist (TSS). This TSS will be in contact with the patient for the next three months; they may visit the patient at the hospital or at outpatient medical appointments. The TSS will also be available to talk with the patient over the telephone. Overall, the TSS will be working with the patient to help with difficulties returning to his or her routine and overcoming physical and emotional pain experienced after the injury. We believe that patients who receive the "new method of treatment," will be more able to return to daily routines and/or cope with the emotional stress that can occur after an injury. Intervention technology innovations including mHealth applications and web-based links will be included in the investigation.

Condition or Disease	Intervention/Treatment	Phase
Posttraumatic Stress Disorder; Depression; Suicide; Traumatic Brain Injury; Alcohol Use; Drug Use	Behavioral: Stepped Care Management	N/A

Detailed Description

Clinical feasibility randomized clinical trial (RCT) pilot of integrating information technology advancements into Early PTSD Screening and Intervention. Design Overview: Between 30-200 injured trauma survivors who are initially admitted to either the Harborview inpatient wards or emergency department acute care settings will be enrolled in the study. If patients agree to participate, they will be engaged by a research assistant to complete a baseline assessment battery. Following the battery, all patients will be engaged in an initial technology readiness assessment to gauge comfort and skill using a variety of devices (e.g., smartphones, cellular phones, tablets, and laptop computers) that could potentially be utilized for delivery of interventions. Patients will then be randomized to either care as usual or to the stepped-care technology-based educational intervention. Patients randomized to the intervention condition will be met by a trauma support specialist. Intervention patients who endorse elevated substance use and/or mental health symptoms, including PTSD, depression, suicidal ideation, chronic pain, and postconcussive symptoms, will receive up to 3 months of motivational interviewing and/or cognitive behavioral therapy delivered by the trauma support specialist in person or over the telephone. The trauma support specialist may utilize mHealth technologies including websites and applications available on smartphones and tablet devices, as strategies to compliment CBT approaches that target specific areas of concern. However, the psychotherapeutic intervention embedded within the Stepped Care protocol is conceived of being fundamentally separate from the mHealth tools that may also be mentioned during discussions between the trauma support specialist and the patient. Inherent throughout the intervention is a focus on obtaining acceptability information from patients related to all aspects of the intervention and interpersonal experiences with the trauma support specialist, as well as any technology-based assessments and mHealth tools that may compliment the stepped care protocol. Patients will receive up to 3 consecutive months of trauma support specialist support post-injury. Follow-up assessments will occur at 1, 3, and 6 months following the baseline assessment, with additional acceptability assessments completed for specific aspects of the intervention listed above.

Study Design

• Study Type: Interventional
• Actual Enrollment: 121 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Integrating Information Technology Advancements Into Early PTSD Interventions
• Actual Study Start Date: Jul 1, 2012
• Actual Primary Completion Date: Aug 1, 2013
• Actual Study Completion Date: Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Stepped Care Management 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 3-6 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 3-6 months.	Behavioral: Stepped Care Management; 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 3-6 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 3-6 months.
No Intervention: 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.

Outcome Measures

Primary Outcome Measures

1. Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury [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.

2. Change in Depression Symptoms Over the Course of the Six Months After Injury [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.

3. Technology Use [Baseline to 6 months]

   The investigators used laptop tracking software to determine technology usage.

4. Feasibility/Acceptability of Intervention [Baseline to 6 months]

   The investigators used laptop tracking software to assess number of patients using laptops.

Secondary Outcome Measures

1. Alcohol Use Problems [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.

2. Physical Functioning [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Score ≥3 on PTSD automated screening algorithm

• Score ≥35 on PTSD checklist (PCL-C)

Exclusion Criteria:

• Non-English speaking

• Under 14 years of age

• Patients in need of acute psychiatric intervention (e.g., suicide attempt, psychosis)

• Suffered head, spinal cord, or other sever injuries that prevent participation in the inpatient ward interview.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Harborview Medical Center	Seattle	Washington	United States	98104

Sponsors and Collaborators

• University of Washington
• National Institute of Mental Health (NIMH)
• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

• Principal Investigator: Douglas Zatzick, M.D., University of Washington

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Douglas Zatzick, Professor of Psychiatry and Behavioral Sciences, University of Washington
• ClinicalTrials.gov Identifier: NCT01625416
• Other Study ID Numbers: STUDY00001473; 1K24MH086814-01; 1R01AA016102-01
• First Posted: Jun 21, 2012
• Last Update Posted: Dec 13, 2017
• Last Verified: Nov 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Douglas Zatzick, Professor of Psychiatry and Behavioral Sciences, University of Washington: Posttraumatic Stress Disorder; Depression; Suicide; Traumatic Brain Injury; Alcohol Use; Drug Use; Information Technology
• Additional relevant MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Depression; Stress Disorders, Traumatic; Suicide; Alcohol Drinking; Stress Disorders, Post-Traumatic

Study Results

Participant Flow

Arm/Group Title	Stepped Care Management	Usual Care
Arm/Group Description	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 control patients will be given a list of available community resources and encouraged to proceed using all resources available to them.
Period Title: Overall Study
STARTED	60	61
COMPLETED	51	54
NOT COMPLETED	9	7

Baseline Characteristics

Arm/Group Title	Stepped Care Management	Usual Care	Total
Arm/Group Description	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 control patients will be given a list of available community resources and encouraged to proceed using all resources available to them.	Total of all reporting groups
Overall Participants	60	61	121
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	55 91.7%	57 93.4%	112 92.6%
>=65 years	5 8.3%	4 6.6%	9 7.4%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	42.8 (14.7)	43.5 (14.8)	43.2 (14.7)
Sex: Female, Male (Count of Participants)
Female	21 35%	22 36.1%	43 35.5%
Male	39 65%	39 63.9%	78 64.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	10 16.7%	8 13.1%	18 14.9%
Not Hispanic or Latino	50 83.3%	53 86.9%	103 85.1%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	5 8.3%	13 21.3%	18 14.9%
Asian	1 1.7%	1 1.6%	2 1.7%
Native Hawaiian or Other Pacific Islander	0 0%	2 3.3%	2 1.7%
Black or African American	14 23.3%	6 9.8%	20 16.5%
White	27 45%	35 57.4%	62 51.2%
More than one race	8 13.3%	3 4.9%	11 9.1%
Unknown or Not Reported	5 8.3%	1 1.6%	6 5%

Outcome Measures

1. Primary Outcome

Title	Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury
Description	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.
Time Frame	The investigators assessed at baseline, 1-, 3-, and 6-month.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stepped Care Management	Usual Care
Arm/Group Description	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 3-6 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 3-6 months.	Usual care control patients will be given a list of available community resources and encouraged to proceed using all resources available to them.
Measure Participants	60	61
Baseline	47.0 (10.2)	47.0 (10.9)
1 month	43.9 (16.1)	43.6 (15.7)
3 month	41.4 (16.0)	45.4 (16.0)
6 month	41.7 (16.2)	47.1 (16.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepped Care Management, Usual Care
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	Chi-squared
	Comments	Chi square (2) =5.9, p=0.05
Other Statistical Analysis		This chi-square analysis was derived from a mixed repeated measures model comparing intervention results with control results over 4 time points.

2. Primary Outcome

Title	Change in Depression Symptoms Over the Course of the Six Months After Injury
Description	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.
Time Frame	The investigators assessed at baseline, 1-, 3-, and 6-month.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stepped Care Management	Usual Care
Arm/Group Description	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 3-6 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 3-6 months.	Usual care control patients will be given a list of available community resources and encouraged to proceed using all resources available to them.
Measure Participants	60	61
Baseline	14.3 (5.7)	15.0 (5.0)
1 month	13.2 (6.3)	13.8 (6.1)
3 month	12.5 (6.4)	14.1 (7.4)
6 month	12.5 (7.2)	14.4 (7.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepped Care Management, Usual Care
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.69
	Comments
	Method	Chi-squared
	Comments	Chi square(2) = 0.74, p = 0.69
Other Statistical Analysis		This chi-square analysis was derived from a mixed repeated measures model comparing intervention results with control results over 4 time points.

3. Primary Outcome

Title	Technology Use
Description	The investigators used laptop tracking software to determine technology usage.
Time Frame	Baseline to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stepped Care Management	Usual Care
Arm/Group Description	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 control patients will be given a list of available community resources and encouraged to proceed using all resources available to them.
Measure Participants	60	61
Mean (Standard Deviation) [minutes]	24.76 (42.51)	16.05 (26.82)

4. Primary Outcome

Title	Feasibility/Acceptability of Intervention
Description	The investigators used laptop tracking software to assess number of patients using laptops.
Time Frame	Baseline to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stepped Care Management	Usual Care
Arm/Group Description	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 control patients will be given a list of available community resources and encouraged to proceed using all resources available to them.
Measure Participants	60	61
Count of Participants [Participants]	37 61.7%	33 54.1%

5. Secondary Outcome

Title	Alcohol Use Problems
Description	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.
Time Frame	The investigators assessed at baseline, 1-, 3-, and 6-month.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stepped Care Management	Usual Care
Arm/Group Description	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 3-6 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 3-6 months.	Usual care control patients will be given a list of available community resources and encouraged to proceed using all resources available to them.
Measure Participants	60	61
Baseline	4.5 (3.4)	4.2 (3.9)
1 month	1.5 (2.7)	1.0 (2.3)
3 month	2.4 (3.1)	1.9 (3.1)
6 month	2.7 (3.0)	2.1 (2.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepped Care Management, Usual Care
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.97
	Comments	Chi square (2) = 0.06, p = 0.97
	Method	Chi-squared
	Comments
Other Statistical Analysis		This chi-square analysis was derived from a mixed repeated measures model comparing intervention results with control results over 4 time points.

6. Secondary Outcome

Title	Physical Functioning
Description	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.
Time Frame	The investigators assessed at baseline, 1-, 3-, and 6-month.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stepped Care Management	Usual Care
Arm/Group Description	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 3-6 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 3-6 months.	Usual care control patients will be given a list of available community resources and encouraged to proceed using all resources available to them.
Measure Participants	60	61
Baseline	47.3 (13.0)	42.8 (14.0)
1 month	27.9 (11.8)	27.4 (11.6)
3 month	35.2 (13.1)	33.6 (13.4)
6 month	36.9 (11.5)	34.6 (12.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stepped Care Management, Usual Care
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.71
	Comments
	Method	Chi-squared
	Comments	Chi-Square (2) =0.68, p=0.71
Other Statistical Analysis		This chi-square analysis was derived from a mixed repeated measures model comparing intervention results with control results over 4 time points.

Adverse Events

Time Frame	6 months
Arm/Group Title	Stepped Care Management		Usual Care
Arm/Group Description	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 control patients will be given a list of available community resources and encouraged to proceed using all resources available to them.
All Cause Mortality
	Stepped Care Management		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/61 (0%)
Serious Adverse Events
	Stepped Care Management		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/61 (0%)
Other (Not Including Serious) Adverse Events
	Stepped Care Management		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	31/60 (51.7%)		36/61 (59%)
Psychiatric disorders
Suicide ideation	31/60 (51.7%)		36/61 (59%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.