Collaborative Care Model for the Treatment of Persistent Symptoms After Concussion Among Youth
NCT03034720 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2021-04-08
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.
Conditions
- Concussion, Brain
- TBI
- Depression
- Anxiety
Interventions
- BEHAVIORAL
-
Collaborative Care
Intervention subjects will receive treatment from an MSW-trained care manager over the course of 6-months after randomization. Intervention team members will work collaboratively with primary care providers to link physical and mental health care longitudinally through outpatient follow-up and community rehabilitation. Intervention subjects and their families and collaborative team members will share information and deliberate treatment decisions with each other in order to develop an individually tailored treatment plan. Stepped, higher intensity care will be available for intervention subjects with recurrent symptoms. Stepped up care will include CBT booster sessions targeting post-concussive and related symptom comorbidity as well as psychopharmacologic assessment and treatment.
Sponsors & Collaborators
-
Seattle Children's Hospital
lead OTHER
Principal Investigators
-
Frederick P Rivara, MD · Seattle Children's Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 11 Years
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-03-09
- Primary Completion
- 2020-05-29
- Completion
- 2020-05-29
Countries
- United States
Study Locations
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