We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Trauma Survivors Outcomes and Support Study IV (TSOS IV)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01625416
First Posted: June 21, 2012
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute of Mental Health (NIMH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Douglas Zatzick, University of Washington
Results First Submitted: June 9, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Posttraumatic Stress Disorder
Depression
Suicide
Traumatic Brain Injury
Alcohol Use
Drug Use
Intervention: Behavioral: Stepped Care Management

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Stepped Care Management   Usual Care
STARTED   60   61 
COMPLETED   51   54 
NOT COMPLETED   9   7 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
   Stepped Care Management   Usual Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 60   61   121 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      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 
[Units: Years]
Mean (Standard Deviation)
 42.8  (14.7)   43.5  (14.8)   43.2  (14.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      21  35.0%      22  36.1%      43  35.5% 
Male      39  65.0%      39  63.9%      78  64.5% 
Ethnicity (NIH/OMB) 
[Units: Participants]
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%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
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   0.0%      2   3.3%      2   1.7% 
Black or African American      14  23.3%      6   9.8%      20  16.5% 
White      27  45.0%      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   5.0% 


  Outcome Measures
  Show All Outcome Measures

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

2.  Primary:   Change in Depression Symptoms Over the Course of the Six Months After Injury   [ Time Frame: The investigators assessed at baseline, 1-, 3-, and 6-month. ]

3.  Secondary:   Alcohol Use Problems   [ Time Frame: The investigators assessed at baseline, 1-, 3-, and 6-month. ]

4.  Secondary:   Physical Functioning   [ Time Frame: The investigators assessed at baseline, 1-, 3-, and 6-month. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide 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.


Results Point of Contact:  
Name/Title: Dr. Douglas Zatzick
Organization: University of Washington
phone: 2067446701
e-mail: dzatzick@uw.edu


Publications of Results:

Responsible Party: Douglas Zatzick, University of Washington
ClinicalTrials.gov Identifier: NCT01625416     History of Changes
Other Study ID Numbers: STUDY00001473
1K24MH086814-01 ( U.S. NIH Grant/Contract )
1R01AA016102-01 ( U.S. NIH Grant/Contract )
First Submitted: June 19, 2012
First Posted: June 21, 2012
Results First Submitted: June 9, 2017
Results First Posted: November 6, 2017
Last Update Posted: November 6, 2017