Collaborative Care Model for the Treatment of Persistent Symptoms After Concussion Among Youth
Condition: Concussion, Brain; TBI; Depression; Anxiety
MeSH terms: Brain Concussion; Depression
Study type: Interventional

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.
    

Detailed description: 
      The proposed study will expand upon the pilot trial in order to further develop, implement,
      and test the impact of an innovative collaborative care approach tailored to the needs of a
      patient population who currently have no evidence-based options. The investigators propose a
      broad reach intervention strategy that is designed to be readily implemented in acute,
      specialty and primary care medical settings, as well as over the telephone. The investigators
      will conduct a randomized comparative effectiveness trial with 200 youth, ages 11-18,
      suffering from ≥ 3 post-concussive symptoms at least 1 month after their sports-related
      injury. Athletes will be randomized to collaborative care (intervention) or post-sports
      injury care as usual (control group) conditions. The study is designed with the following
      aims:

      Aim 1. To determine the effectiveness of a stepped-collaborative care intervention model in
      reducing post-concussive and co-occurring psychological symptoms in youth with persistent
      post-concussive symptoms after sports-related concussion H1: Youth receiving a collaborative
      care intervention will demonstrate clinically and statistically significant reductions in
      post-concussive symptoms, depressive and anxiety symptoms over the course of the 12-month
      study, compared to usual care control group athletes Aim 2. To examine the effectiveness of
      the intervention in improving function and health-related quality of life amongst youth with
      persistent symptoms after sports-related concussion H2: Adolescents who receive a
      collaborative care intervention will exhibit a clinically meaningful improvement in function
      and health-related quality life Exploratory Aim 3. To explore differences in school
      performance between groups H3: Adolescents who receive the collaborative care intervention
      will receive individualized treatment and community resource linkages which will improve
      their school performance as compared to adolescents receiving treatment as usual Aim 4. To
      explore the heterogeneity of treatment effects in the primary and secondary outcomes by
      examining the interaction of the treatment effect with group membership in distinct subgroups
      of the population. H4: Three distinct subgroups are expected to emerge from the study
      population: adolescents who recover from symptoms, adolescents with chronic psychosocial
      problems, and adolescents whose symptoms wax and wane over time. A greater proportion of
      adolescents who recover from symptoms will emerge in the treatment group, compared to
      controls.

      IMPACT: By broadly targeting the constellation of post-concussive physical and psychological
      symptoms and integrating care amongst primary care, pediatric sub-specialist, and behavioral
      health providers, the collaborative care health services intervention could accelerate the
      rate of recovery from persistent post-concussive symptoms and attenuate the degree and
      duration of disability during adolescence, a critical period for healthy development.
      Validation of this treatment through a scaled up clinical trial will serve as a foundation
      for broader dissemination of this collaborative care treatment model. The multidisciplinary
      sports concussion research team will simultaneously work nationally and internationally to
      ensure study results are expediently translated into effective policy for youth athletes
      suffering from enduring symptoms and functional impairments in the wake of sports-related
      concussions.
    

Intervention name(s): Collaborative Care
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Concussion; persistent post-concussive symptoms; CBT; collaborative care; Depression; Anxiety