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
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Douglas Zatzick, University of Washington
ClinicalTrials.gov Identifier:
NCT01625416
First received: June 19, 2012
Last updated: January 14, 2013
Last verified: June 2012
  Purpose

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 Intervention
Posttraumatic Stress Disorder
Depression
Suicide
Traumatic Brain Injury
Alcohol Use
Drug Use
Behavioral: Case management, information technology/mHealth innovations, psychotherapy, and psychopharmacology.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Integrating Information Technology Advancements Into Early PTSD Interventions

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • PTSD ratings [ Time Frame: Up to 6 months after injury ] [ Designated as safety issue: No ]
    Assessed using the Posttraumatic Stress Disorder Checklist (PCL-C) and suicide ratings.

  • Depression ratings [ Time Frame: Up to 6 months after injury ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Assessed by feasibility and acceptability measures created for this study.


Secondary Outcome Measures:
  • Substance use [ Time Frame: Up to 6 months after injury ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Assessed using the Posttraumatic Growth Inventory (PTGI) and Satisfaction with Care(NSCOT)

  • Injury relapse [ Time Frame: Up to 5 years after injury ] [ Designated as safety issue: No ]
    Assessed using Healthcare Utilization Questions (NSCOT)

  • Work, disability, and legal outcomes [ Time Frame: Up to 6 months after injury ] [ Designated as safety issue: No ]
    Assessed using Work, Disability and Legal (NSCOT) and Sheehan Disability Scale (SDS)


Estimated Enrollment: 120
Study Start Date: July 2012
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stepped Care Management 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.
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.

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.

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01625416

Contacts
Contact: Douglas Zatzick, M.D. 206-744-6701 dzatzick@uw.edu
Contact: Collin McFadden, B.A. 206-744-1759 mcfadde1@uw.edu

Locations
United States, Washington
Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: Collin McFadden, B.A.    206-744-1759    mcfadde1@uw.edu   
Principal Investigator: Douglas Zatzick, M.D.         
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Douglas Zatzick, M.D. University of Washington
  More Information

No publications provided

Responsible Party: Douglas Zatzick, Professor & Medical Director Psychiatric Consultation Liaison Service, University of Washington
ClinicalTrials.gov Identifier: NCT01625416     History of Changes
Other Study ID Numbers: 42937 C, 1K24MH086814-01, 1R01AA016102-01
Study First Received: June 19, 2012
Last Updated: January 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Posttraumatic Stress Disorder
Depression
Suicide
Traumatic Brain Injury
Alcohol Use
Drug Use
Information Technology

Additional relevant MeSH terms:
Depressive Disorder
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Mood Disorders
Mental Disorders
Anxiety Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Alcohol Drinking
Depression
Suicide
Brain Injuries
Wounds and Injuries
Drinking Behavior
Behavioral Symptoms
Self-Injurious Behavior
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on August 21, 2014