Clinical trial NCT01625416: Trauma Survivors Outcomes and Support Study IV
Official title: Integrating Information Technology Advancements Into Early PTSD Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2012-06-21
Enrollment: 121
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury
timeFrame: The investigators assessed at baseline, 1-, 3-, and 6-month.
measure: Change in Depression Symptoms Over the Course of the Six Months After Injury
timeFrame: The investigators assessed at baseline, 1-, 3-, and 6-month.
measure: Technology Use
timeFrame: Baseline to 6 months
measure: Feasibility/Acceptability of Intervention
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Alcohol Use Problems
timeFrame: The investigators assessed at baseline, 1-, 3-, and 6-month.
measure: Physical Functioning
timeFrame: The investigators assessed at baseline, 1-, 3-, and 6-month.
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Douglas Zatzick, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.