NCT03034720

Collaborative Care Model for the Treatment of Persistent Symptoms After Concussion Among Youth

Completed NA Last updated 8 April 2021

What this trial tests

NA trial testing Collaborative Care in Concussion, Brain in 200 participants. Completed in 29 May 2020.

Timeline

9 March 2017

Primary endpoint
29 May 2020

29 May 2020

Quick facts

Lead sponsor	Seattle Children's Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	200
Start date	9 March 2017
Primary completion	29 May 2020
Estimated completion	29 May 2020
Sites	1 location across United States

Drugs / interventions tested

• Collaborative Care

Conditions studied

• Concussion, Brain — all drugs for Concussion, Brain →
• TBI — all drugs for TBI →
• Depression — all drugs for Depression →
• Anxiety — all drugs for Anxiety →

Sponsor

Seattle Children's Hospital

Who can join

Adults 11 to 18, any sex, with Concussion, Brain or TBI. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effect of Collaborative Care on Persistent Postconcussive Symptoms in Adolescents: A Randomized Clinical Trial.
   McCarty CA, Zatzick DF, Marcynyszyn LA, Wang J, et al · · 2021 · cited 42× · PMID 33635325 · DOI 10.1001/jamanetworkopen.2021.0207
2. Collaborative care model for treatment of persistent symptoms after concussion among youth (CARE4PCS-II): Study protocol for a randomized, controlled trial.
   McCarty CA, Zatzick D, Hoopes T, Payne K, et al · · 2019 · cited 18× · PMID 31533799 · DOI 10.1186/s13063-019-3662-3
3. Prevalence and risk factors for depression, anxiety and suicidal ideation in youth with persistent post-concussive symptoms (PPCS).
   Chrisman SPD, Whelan BM, Zatzick DF, Hilt RJ, et al · · 2021 · cited 14× · PMID 34841998 · DOI 10.1080/02699052.2021.2008490
4. Psychometric Properties and Validation of the General Anxiety Disorder 7-Item Scale Among Adolescents With Persistent Post-Concussive Symptoms.
   Marcynyszyn LA, McCarty CA, Chrisman SPD, Zatzick DF, et al · · 2023 · cited 4× · PMID 37139182 · DOI 10.1089/neur.2022.0075
5. Effect of Collaborative Care for Persistent Postconcussive Symptoms on Academic Function: A Randomized Clinical Trial.
   Rivara FP, Marcynyszyn LA, Wang J, Chrisman SPD, et al · · 2022 · cited 2× · PMID 34904238 · DOI 10.1111/josh.13123
6. Parent Traumatic Events and Adolescent Internalizing Symptoms: The Mediating Role of Parental Depression Among Youth with Persistent Post-concussive Symptoms.
   Marcynyszyn LA, McCarty CA, Rivara FP, Johnson AM, et al · · 2021 · cited 1× · PMID 33411915 · DOI 10.1093/jpepsy/jsaa128