Ignite Creation Date:
2024-05-06 @ 1:45 AM
Last Modification Date:
2024-10-26 @ 11:09 AM
Study NCT ID:
NCT01893970
Status:
UNKNOWN
Last Update Posted:
2016-04-27
First Post:
2013-06-28
Brief Title:
SWIFT Study in the ED
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Social Work Intervention for Adults With Mild Traumatic Brain Injury SWIFT Pilot Study
Status:
UNKNOWN
Status Verified Date:
2016-04
Last Known Status:
RECRUITING
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:
SWIFT
Brief Summary:
Mild traumatic brain injury mTBI is a prevalent and costly public health problem with disabling consequences More than one million civilians with mTBI are treated in US hospitals and emergency departments each year Faul et al 2010 While the exact number is debated approximately 10-15 of individuals with mTBI will experience prolonged and disabling post-concussive symptoms Stranjalis et al 2008 Ruff and Weyer Jamora 2009 and 34 will experience a psychiatric illness in the first year after injury Fann et al 2004 In addition at least 188270 military service members sustained a TBI from 2000 to mid August 2010 and nearly 77 of these injuries were mild Defense and Veterans Brain Injury Center 2010 Many individuals require treatment for resulting mTBI symptoms
The proposed study builds on preliminary research conducted by the investigators to develop and test the effectiveness of a social work delivered education and reassurance intervention for adults with mTBI SWIFT-Acute against usual care The proposed study will assess acceptability and obtain preliminary effectiveness data for an enhanced social work assessment and intervention for adults with mTBI SWIFT discharged from the Emergency Department ED SWIFT includes early education reassurance coping strategies resources and a brief alcohol use intervention in the ED plus follow up telephone counseling needs assessment and case management referral to necessary services The intervention targets cognitive physical psychiatric and functional outcomes specifically post-concussive symptoms depression anxiety posttraumatic stress disorder alcohol use community functioning and successful linkage to community resources
It is hypothesized that SWIFT will be acceptable to patients and that participants in the SWIFT group will report superior outcomes on measures of post-concussive symptoms depression and anxiety alcohol use and community functioning and will report increased successful linkages to needed resources when compared to the SWIFT-Acute group
The specific aims of the study are
1 Implement an innovative social work intervention for adults with mTBI SWIFT
2 Assess acceptability of SWIFT using qualitative interviews with participants
3 Assess preliminary effectiveness of SWIFT compared to SWIFT-Acute alone on reduction or prevention of post-concussive symptoms depression anxiety posttraumatic stress disorder PTSD symptoms and alcohol use and on improvement of community functioning and successful linkage to community resources 80 participants will be randomized to receive SWIFT or SWIFT-Acute Preliminary intervention effectiveness will be assessed using standard measures of post-concussive symptoms the primary outcome depression anxiety PTSD alcohol use and community functioning A structured survey will be used to assess linkage to community resources
The proposed study builds on preliminary research conducted by the investigators to develop and test the effectiveness of a social work delivered education and reassurance intervention for adults with mTBI SWIFT-Acute against usual care The proposed study will assess acceptability and obtain preliminary effectiveness data for an enhanced social work assessment and intervention for adults with mTBI SWIFT discharged from the Emergency Department ED SWIFT includes early education reassurance coping strategies resources and a brief alcohol use intervention in the ED plus follow up telephone counseling needs assessment and case management referral to necessary services The intervention targets cognitive physical psychiatric and functional outcomes specifically post-concussive symptoms depression anxiety posttraumatic stress disorder alcohol use community functioning and successful linkage to community resources
It is hypothesized that SWIFT will be acceptable to patients and that participants in the SWIFT group will report superior outcomes on measures of post-concussive symptoms depression and anxiety alcohol use and community functioning and will report increased successful linkages to needed resources when compared to the SWIFT-Acute group
The specific aims of the study are
1 Implement an innovative social work intervention for adults with mTBI SWIFT
2 Assess acceptability of SWIFT using qualitative interviews with participants
3 Assess preliminary effectiveness of SWIFT compared to SWIFT-Acute alone on reduction or prevention of post-concussive symptoms depression anxiety posttraumatic stress disorder PTSD symptoms and alcohol use and on improvement of community functioning and successful linkage to community resources 80 participants will be randomized to receive SWIFT or SWIFT-Acute Preliminary intervention effectiveness will be assessed using standard measures of post-concussive symptoms the primary outcome depression anxiety PTSD alcohol use and community functioning A structured survey will be used to assess linkage to community resources
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None