Trauma Survivors Outcomes and Support Study IV
| Status: | Completed |
|---|---|
| Conditions: | Depression, Hospital, Neurology, Psychiatric |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 14 - Any |
| Updated: | 12/15/2017 |
| Start Date: | July 2012 |
| End Date: | October 2015 |
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.
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.
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.
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.
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.
We found this trial at
1
site
325 9th Ave
Seattle, Washington 98104
Seattle, Washington 98104
(206) 744-3300
Principal Investigator: Douglas Zatzick, M.D.
Phone: 206-744-1759
Harborview Medical Center Harborview Medical Center is the only designated Level 1 adult and pediatric...
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