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: December 13, 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
  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: Stepped Care Management

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

Resource links provided by NLM:


Further study details as provided by Douglas Zatzick, University of Washington:

Primary Outcome Measures:
  • 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. ]
    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.

  • 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. ]
    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.

  • Technology Use [ Time Frame: Baseline to 6 months ]
    The investigators used laptop tracking software to determine technology usage.

  • Feasibility/Acceptability of Intervention [ Time Frame: Baseline to 6 months ]
    The investigators used laptop tracking software to assess number of patients using laptops.


Secondary Outcome Measures:
  • Alcohol Use Problems [ Time Frame: 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.

  • Physical Functioning [ Time Frame: 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.


Enrollment: 121
Actual Study Start Date: July 2012
Study Completion Date: October 2015
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
  • 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01625416


Locations
United States, Washington
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
  More Information

Publications:
Responsible Party: Douglas Zatzick, Professor of Psychiatry and Behavioral Sciences, 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: December 13, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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

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