Mild Traumatic Brain InjurySWIFTNCT01893970
SWIFT Study in the ED
A study testing SWIFT and SWIFT-Acute in people with Mild Traumatic Brain Injury, run by University of Washington at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild Traumatic Brain Injury
- What is being tested?
- SWIFT and SWIFT-Acute
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusion criteria are based on the World Health Organization definition of mTBI. For inclusion in the study, participants must meet following criteria:
- At least 18 years of age and English speakers
- Present to ED with mechanism of trauma to the head, non-penetrating injury, or recent history of trauma to the head
- Glasgow Coma Scale score of 13-15 after 30 minutes post injury or later upon presentation for healthcare
- Discharged from the ED in <48 hours from time of admission
- In addition participants must have one or more of the following symptoms at time of injury:
Show all 10Show fewer
- confusion or disorientation
- loss of consciousness for 30 minutes or less,
- post-traumatic amnesia for less than 24 hours
- other transient neurological abnormalities such as focal signs, seizure and intracranial lesion not requiring surgery
Who cannot join
- the manifestations of mTBI are determined to be caused by penetrating craniocerebral injury
- patients <18 years of age or non-English speaking
- patients with intracranial lesion requiring surgery
- patients admitted to the hospital from ED
- patients in police custody
- patients without a telephone contact number
Trial locations and contacts
1 site in 1 country.
Megan Moore, MSW, PhD contact
United States1 site, 1 recruiting
- Recruiting
UCSF San Francisco General Hospital and Trauma Center
San Francisco, California, 94110
Geoffrey Manley, MD, PhD, ManleyG@neurosurg.ucsf.edu
Geoffrey Manley, MD, PhD
About this study
Official title: Social Work Intervention for Adults With Mild Traumatic Brain Injury: SWIFT Pilot Study
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 188,270 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.
Read more
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:
- Implement an innovative social work intervention for adults with mTBI (SWIFT).
- Assess acceptability of SWIFT using qualitative interviews with participants.
- 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.
- Conditions
- Mild Traumatic Brain Injury
- Being tested
- SWIFT, SWIFT-Acute
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SWIFTBehavioural
Participants will receive: 1) acute social work intervention for adults with mTBI, including early education, reassurance, resources and brief alcohol intervention in the ED (SWIFT-Acute) and 2) follow up telephone counseling, needs assessment and case management referral to necessary services (SWIFT).
SWIFT-AcuteBehavioural
acute social work intervention for adults with mTBI, including early education, reassurance, resources and brief alcohol intervention in the ED (SWIFT-Acute)
| Study group | Role | What they receive |
|---|---|---|
| SWIFT: Acute Social Work Intervention in the ED and Follow Up | Experimental | Participants will receive: 1) acute social work intervention for adults with mTBI, including early education, reassurance, resources and brief alcohol intervention in the ED (SWIFT-Acute) and 2) follow up telephone counseling, needs assessment and case management referral to necessary services (SWIFT). Receives: Behavioral: SWIFT |
| SWIFT-Acute Only: Acute social work intervention in the ED | Active comparator | acute social work intervention for adults with mTBI, including early education, reassurance, resources and brief alcohol intervention in the ED (SWIFT-Acute) Receives: Behavioral: SWIFT-Acute |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Rivermead Postconcussion Symptoms Questionnaire (RPQ)
Measured: baseline, 3mo, 6mo
Secondary outcomes (8)
Change in Headache Impact Test (HIT-6)
Measured: baseline, 3mo, 6mo
Change in Insomnia Severity Index (ISI)
Measured: baseline, 3mo, 6mo
Change in The Post Traumatic Stress Disorder Checklist (PCL-C)
Measured: baseline, 3mo, 6mo
Change in Cornell Service Index
Measured: baseline, 3mo, 6mo
Change in The Alcohol Use Disorders Identification Test (AUDIT)
Measured: baseline, 3mo, 6mo
Change in Community Integration Questionnaire (CIQ)
Measured: baseline, 3mo, 6mo
Change in Patient Health Questionnaire (PHQ)-9
Measured: baseline, 3mo, 6mo
Change in Generalized Anxiety Disorder (GAD)-7
Measured: baseline, 3mo, 6mo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2013 (estimated)
- Study startApr 2013
- Primary completionJul 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco
- Responsible party
- Principal investigator, Megan Moore, University of Washington
- Investigators
- Megan Moore, MSW, PHD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01893970
- Sponsor's protocol ID
- 44360-J
- Acronym
- SWIFT
- Status last verified
- Apr 2016
- First submitted
- 28 Jun 2013
- Last updated
- 27 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Work Intervention for Adults With Mild Traumatic Brain Injury: SWIFT Pilot Study
- ClinicalTrials.gov ID
- NCT01893970
- Acronym / sponsor ID
- SWIFT / 44360-J
- Conditions
- Mild Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- University of California, San Francisco
- Study start
- Apr 2013
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 9 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 188,270 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:
- Implement an innovative social work intervention for adults with mTBI (SWIFT).
- Assess acceptability of SWIFT using qualitative interviews with participants.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SWIFT: Acute Social Work Intervention in the ED and Follow Up | Experimental | Behavioral: SWIFTParticipants will receive: 1) acute social work intervention for adults with mTBI, including early education, reassurance, resources and brief alcohol intervention in the ED (SWIFT-Acute) and 2) follow up telephone counseling, needs assessment and case management referral to necessary services (SWIFT). |
| SWIFT-Acute Only: Acute social work intervention in the ED | Active comparator | Behavioral: SWIFT-Acuteacute social work intervention for adults with mTBI, including early education, reassurance, resources and brief alcohol intervention in the ED (SWIFT-Acute) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Inclusion criteria are based on the World Health Organization definition of mTBI. For inclusion in the study, participants must meet following criteria:
- At least 18 years of age and English speakers
- Present to ED with mechanism of trauma to the head, non-penetrating injury, or recent history of trauma to the head
- Glasgow Coma Scale score of 13-15 after 30 minutes post injury or later upon presentation for healthcare
- Discharged from the ED in <48 hours from time of admission
Key exclusion criteria (6 listed)
- the manifestations of mTBI are determined to be caused by penetrating craniocerebral injury
- patients <18 years of age or non-English speaking
- patients with intracranial lesion requiring surgery
- patients admitted to the hospital from ED
- patients in police custody
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SWIFTParticipants will receive: 1) acute social work intervention for adults with mTBI, including early education, reassurance, resources and brief alcohol intervention in the ED (SWIFT-Acute) and 2) follow up telephone counseling, needs assessment and case management referral to necessary services (SWIFT). | Behavioural | SWIFT: Acute Social Work Intervention in the ED and Follow Up |
| SWIFT-Acuteacute social work intervention for adults with mTBI, including early education, reassurance, resources and brief alcohol intervention in the ED (SWIFT-Acute) | Behavioural | SWIFT-Acute Only: Acute social work intervention in the ED |
Primary outcome
Change in Rivermead Postconcussion Symptoms Questionnaire (RPQ)
Time frame: baseline, 3mo, 6mo
8 secondary outcomes
Change in Headache Impact Test (HIT-6)
Time frame: baseline, 3mo, 6mo
Change in Insomnia Severity Index (ISI)
Time frame: baseline, 3mo, 6mo
Change in The Post Traumatic Stress Disorder Checklist (PCL-C)
Time frame: baseline, 3mo, 6mo
Change in Cornell Service Index
Time frame: baseline, 3mo, 6mo
Change in The Alcohol Use Disorders Identification Test (AUDIT)
Time frame: baseline, 3mo, 6mo
Change in Community Integration Questionnaire (CIQ)
Time frame: baseline, 3mo, 6mo
Change in Patient Health Questionnaire (PHQ)-9
Time frame: baseline, 3mo, 6mo
Change in Generalized Anxiety Disorder (GAD)-7
Time frame: baseline, 3mo, 6mo
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan Moore, MSW, PhD contact
Megan Moore, MSW, PHD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SWIFT and SWIFT-Acute in people with Mild Traumatic Brain Injury, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Megan Moore, MSW, PhD (mm99@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Rivermead Postconcussion Symptoms Questionnaire (RPQ) (time frame: baseline, 3mo, 6mo). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2016.