Early Intervention Programme for Young Patients (Aged 15 - 30 Years) With Symptoms Following Concussion.

Summary

Background:

Five - 15 % of patients with concussion continue to experience impairing physical, cognitive and emotional symptoms longer than 3 months post-injury. Currently, no standardised treatment is available for patients with persistent post-concussional symptoms (PCS) and systematic treatment studies remain limited.

Aim:

1. to develop an early intervention programme based on principles from cognitive-behavioural therapy and graded exercise for young patients with PCS lasting more than 3 months, and
2. to evaluate the efficacy of this intervention on PCS in a randomised, controlled trial.

Methods:

Patients aged 15 - 30 years diagnosed with concussion at hospitals in Central Denmark Region will be screened for persistent symptoms two months post-injury. Those with impairing symptoms will be invited to participate in a randomised controlled trial comparing the early intervention programme with enhanced usual care. We expect to include 120 patients from 2015-2016. Treatment will be interdisciplinary and will begin approximately 3 - 5 months after concussion. All patients will complete self-report measures at baseline and 3, 6 and 15 months after randomisation. The primary outcome is severity of PCS.

Conditions

• Brain Concussion
• Post-Concussion Syndrome

Interventions

OTHER

Enhanced Usual Care (EUC)

All patients will have a brief clinical psychiatric and neurological assessment in order to determine eligibility, and will be provided with information and advice about typical post-concussional symptoms, the typical recovery process and the use of pain medication.

BEHAVIORAL

EUC + Early intervention programme

All patients will have a brief clinical psychiatric and neurological assessment in order to determine eligibility, and will be provided with information and advice about typical post-concussional symptoms, the typical recovery process and the use of pain medication. The early intervention programme will be interdisciplinary and will mainly be provided by an occupational therapist and a physiotherapist under supervision of a neuropsychologist. It will be based on psychoeducation and principles from Cognitive Behavioral Therapy and Graded Exercise Therapy and targeted to patients' individual goals. Patients will receive 8 weekly treatment sessions (3 group based and 5 individual sessions). Intervention will start approximately 4-5 months after the concussion.

Sponsors & Collaborators

• Aarhus University Hospital

  collaborator OTHER

• Central Denmark Region

  collaborator OTHER

• Regionshospitalet Hammel Neurocenter

  collaborator OTHER

• University of Aarhus

  lead OTHER

Principal Investigators

• Andreas Schröder, MD, PhD · Aarhus University Hospital

• Charlotte U Rask, MD, PhD · Aarhus University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

15 Years

Max Age

30 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-03-31

Primary Completion

2018-07-31

Completion

2019-04-30

Countries

• Denmark

Study Locations