Trauma Survivors Outcomes and Support Study IV (TSOS 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.

Study Overview

• Status: Completed
• Conditions: Depression; Suicide; Traumatic Brain Injury; Alcohol Use; Posttraumatic Stress Disorder; Drug Use
• Intervention / Treatment: Behavioral: Stepped Care Management

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 Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98104
      • Harborview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Depression Symptoms Over the Course of the Six Months After Injury	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.	The investigators assessed at baseline, 1-, 3-, and 6-month.
Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury	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.	The investigators assessed at baseline, 1-, 3-, and 6-month.
Technology Use	The investigators used laptop tracking software to determine technology usage.	Baseline to 6 months
Feasibility/Acceptability of Intervention	The investigators used laptop tracking software to assess number of patients using laptops.	Baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol Use Problems	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.	The investigators assessed at baseline, 1-, 3-, and 6-month.
Physical Functioning	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.	The investigators assessed at baseline, 1-, 3-, and 6-month.

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA); National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Douglas Zatzick, M.D., University of Washington

Publications and helpful links

General Publications

• 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.
• Kelly CM, Van Eaton EG, Russo JE, Kelly VC, Jurkovich GJ, Darnell DA, Whiteside LK, Wang J, Parker LE, Payne TH, Mooney SD, Bush N, Zatzick DF. Technology Use, Preferences, and Capacity in Injured Patients at Risk for Posttraumatic Stress Disorder. Psychiatry. 2017 Fall;80(3):279-285. doi: 10.1080/00332747.2016.1271162.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2012
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: June 19, 2012
• First Submitted That Met QC Criteria: June 20, 2012
• First Posted (Estimate): June 21, 2012

Study Record Updates

• Last Update Posted (Actual): December 13, 2017
• Last Update Submitted That Met QC Criteria: November 17, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Depression; Suicide; Posttraumatic Stress Disorder; Traumatic Brain Injury; Alcohol Use; Drug Use; Information Technology
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Drinking Behavior; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Trauma and Stressor Related Disorders; Self-Injurious Behavior; Alcohol Drinking; Depression; Brain Injuries; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Brain Injuries, Traumatic; Suicide
• Other Study ID Numbers: STUDY00001473; 1R01AA016102-01 (U.S. NIH Grant/Contract); 1K24MH086814-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No