Ignite Creation Date:
2024-05-06 @ 12:39 AM
Last Modification Date:
2024-10-26 @ 10:53 AM
Study NCT ID:
NCT01625416
Status:
COMPLETED
Last Update Posted:
2017-12-13
First Post:
2012-06-19
Brief Title:
Trauma Survivors Outcomes and Support Study IV
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Integrating Information Technology Advancements Into Early PTSD Interventions
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TSOS IV
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 andor 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
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 andor 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 eg 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 andor mental health symptoms including PTSD depression suicidal ideation chronic pain and postconcussive symptoms will receive up to 3 months of motivational interviewing andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01AA016102-01 | NIH | None | httpsreporternihgovquickSearch1R01AA016102-01 |
| 1K24MH086814-01 | NIH | None | None |