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Trauma Survivors Outcomes and Support Study IV (TSOS IV)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by University of Washington
National Institute of Mental Health (NIMH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Douglas Zatzick, University of Washington Identifier:
First received: June 19, 2012
Last updated: January 14, 2013
Last verified: June 2012

June 19, 2012
January 14, 2013
July 2012
January 2014   (Final data collection date for primary outcome measure)
  • PTSD ratings [ Time Frame: Up to 6 months after injury ]
    Assessed using the Posttraumatic Stress Disorder Checklist (PCL-C) and suicide ratings.
  • Depression ratings [ Time Frame: Up to 6 months after injury ]
    Assessed using the Personal Health Questionnaire (PHQ-9)and the Scale for Suicide Ideation (SSI)
  • Technology use and acceptability [ Time Frame: Up to 6 months after injury ]
    Assessed using Personal Technology Survey and Acceptability Measures created for this study.
  • Feasibility and Acceptability of Intervention [ Time Frame: Up to 6 months after injury ]
    Assessed by feasibility and acceptability measures created for this study.
Same as current
Complete list of historical versions of study NCT01625416 on Archive Site
  • Substance use [ Time Frame: Up to 6 months after injury ]
    Assessed using the Alcohol Use Disorders Identification Test (AUDIT) and The Drug Abuse Screening Test (DAST)
  • General functioning reports [ Time Frame: Up to 6 months after injury ]
    Assessed using the SF-12 Health Survey, Sheehan Disability Scale (SDS), and Functional Capacity Index (FCI)
  • Increased satisfaction with global care [ Time Frame: Up to 6 months after injury ]
    Assessed using the Posttraumatic Growth Inventory (PTGI) and Satisfaction with Care(NSCOT)
  • Injury relapse [ Time Frame: Up to 5 years after injury ]
    Assessed using Healthcare Utilization Questions (NSCOT)
  • Work, disability, and legal outcomes [ Time Frame: Up to 6 months after injury ]
    Assessed using Work, Disability and Legal (NSCOT) and Sheehan Disability Scale (SDS)
Same as current
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Trauma Survivors Outcomes and Support Study IV
Integrating Information Technology Advancements Into Early PTSD Interventions

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.

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.
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
  • Posttraumatic Stress Disorder
  • Depression
  • Suicide
  • Traumatic Brain Injury
  • Alcohol Use
  • Drug Use
Behavioral: 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.
  • Experimental: Stepped Care Management
    Intervention: Behavioral: Case management, information technology/mHealth innovations, psychotherapy, and psychopharmacology.
  • 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.
Zatzick D, O'Connor SS, Russo J, Wang J, Bush N, Love J, Peterson R, Ingraham L, Darnell D, Whiteside L, Van Eaton E. Technology-Enhanced Stepped Collaborative Care Targeting Posttraumatic Stress Disorder and Comorbidity After Injury: A Randomized Controlled Trial. J Trauma Stress. 2015 Oct;28(5):391-400. doi: 10.1002/jts.22041.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2019
January 2014   (Final data collection date for primary outcome measure)

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
  • Suffered head, spinal cord, or other sever injuries that prevent participation in the inpatient ward interview.
Sexes Eligible for Study: All
14 Years and older   (Child, Adult, Senior)
Contact: Douglas Zatzick, M.D. 206-744-6701
Contact: Collin McFadden, B.A. 206-744-1759
United States
42937 C
1K24MH086814-01 ( US NIH Grant/Contract Award Number )
1R01AA016102-01 ( US NIH Grant/Contract Award Number )
Not Provided
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Douglas Zatzick, University of Washington
University of Washington
  • National Institute of Mental Health (NIMH)
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Douglas Zatzick, M.D. University of Washington
University of Washington
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP