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NCT03034720 · ClinicalTrials.gov registry record · NA
Collaborative Care Model for the Treatment of Persistent Symptoms After Concussion Among Youth
A NA study, sponsored by Seattle Children's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 200
- Enrollment target
NCT03034720 is a NA study that has completed, run by Seattle Children's Hospital. The registered enrollment target is 200 participants.
The verdict
NCT03034720, a NA study, has completed, sponsored by Seattle Children's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
Study Summary
SPECIFIC AIMS While post-concussive symptoms following sports-related concussion are typically transient and resolve spontaneously within two weeks of concussive injury, 14% or more of youth who sustain concussion experience significant morbidity that can persist well beyond the normal disease course.Furthermore, post-concussive symptoms commonly co-occur with affective symptoms including depression and anxiety which when present can prolong recovery from primary post-concussive symptoms. Together, persistent physical and psychological symptoms confer protracted functional impairment and create a significant burden for affected youth, their family, and school. Currently, there are no evidence-based guidelines to inform treatment of persistent post-concussive symptoms in youth and adolescents. In response to the dearth of evidence-based treatment approaches for youth with persistent post-concussive symptoms, the investigators developed a novel collaborative care treatment model that simultaneously targets post-concussive symptoms and co-occurring depression and anxiety. Athletes and their family members receive patient navigator care management services that bridge post-injury care across acute care, specialist and primary care health service delivery sectors, in addition to cognitive behavioral psychotherapy. Patients who remain symptomatic after initial treatment efforts receive stepped-up care that may include psychopharmacologic consultation. The Investigators have demonstrated feasibility of the intervention model through a pilot randomized-control trial of 49 adolescents with persistent post-concussive symptoms recruited from a regional children's hospital. Participants assigned to the intervention condition demonstrated significant and clinically-meaningful reductions in post-concussive and depressive symptoms as well as health-related quality of life as compared to adolescents in the usual care arm of the trial.
Interventions
- BEHAVIORAL Collaborative Care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2017-03-09 |
| Est. Completion | 2020-05-29 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03034720
The ClinicalTrials.gov registry entry for NCT03034720 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seattle Children's Hospital, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Collaborative Care is the first listed.
NCT03034720 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03034720 about?
NCT03034720 is a clinical study titled "Collaborative Care Model for the Treatment of Persistent Symptoms After Concussion Among Youth". SPECIFIC AIMS While post-concussive symptoms following sports-related concussion are typically transient and resolve spontaneously within two weeks of concussive injury, 14% or more of youth who sustain concussion experience significant morbidity that can persist well beyond the normal disease cour...
What is the current status of trial NCT03034720?
This trial is currently completed. It is a NA study. The enrollment target is 200 participants. The study started on 2017-03-09. Estimated completion is 2020-05-29.
What interventions are being tested in trial NCT03034720?
The interventions under investigation include: Collaborative Care (BEHAVIORAL).
Who is sponsoring clinical trial NCT03034720?
This trial is sponsored by Seattle Children's Hospital, which has 168 total clinical trials registered on ClinicalTrials.gov.
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