Trauma Survivors Outcomes and Support Study IV

NCT01625416 | Completed Results DMC

• 3 other identifiers: STUDY000014731K24MH086814-011R01AA016102-01
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Posttraumatic Stress Disorder; Depression; Suicide; Traumatic Brain Injury; Alcohol Use; Drug Use

Keywords

Posttraumatic Stress Disorder; Depression; Suicide; Traumatic Brain Injury; Alcohol Use; Drug Use; Information Technology

Outcome Measures

Primary Outcomes (4)

• 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.

• 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.

• 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 Outcomes (2)

• Alcohol Use Problems

  The investigators assessed at baseline, 1-, 3-, and 6-month.

• Physical Functioning

  The investigators assessed at baseline, 1-, 3-, and 6-month.

Study Arms (2)

Stepped Care Management

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

Usual care control patients will be given a list of available community resources and encouraged to proceed using all resources available to them.

Interventions

Stepped Care Management BEHAVIORAL

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.

Stepped Care Management

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Score ≥3 on PTSD automated screening algorithm
• Score ≥35 on PTSD checklist (PCL-C)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Mental Health (NIMH): collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Related Publications (2)

• 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.

  PMID: 26467327 RESULT

• 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.

  PMID: 29087256 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression; Suicide; Brain Injuries, Traumatic; Alcohol Drinking

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Self-Injurious Behavior; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Drinking Behavior

Results Point of Contact

• Title: Dr. Douglas Zatzick
• Organization: University of Washington

dzatzick@uw.edu

2067446701

Study Officials

• Douglas Zatzick, M.D.

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: June 19, 2012
• First Posted: June 21, 2012
• Study Start: July 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: October 1, 2015
• Last Updated: December 13, 2017
• Results First Posted: November 6, 2017

Record last verified: 2017-11

Locations

US (1)