Early Intervention Programme for Young Patients (Aged 15 - 30 Years) With Symptoms Following Concussion.
Condition: Brain Concussion; Post-Concussion Syndrome
MeSH terms: Post-Concussion Syndrome; Brain Concussion
Study type: Interventional

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.
    

Detailed description: 
      Background Concussion is an important public health concern. Debilitating and persistent
      post-concussional symptoms are associated with considerable long-term sickness and markedly
      reduced health-related quality of life in industrialized countries. In Denmark, approximately
      25000 people are diagnosed with concussion each year. Although complete resolution of typical
      post-concussional symptoms such as headaches, dizziness and fatigue normally occur within the
      first days or weeks after a concussion, a significant proportion corresponding to five to15 %
      of patients continue to experience symptoms longer than 3 months post-injury. These patients
      are at risk of long-term sickness, reduced health-related quality of life as well as
      permanently reduced working ability, which is particularly disastrous for adolescents and
      young adults. Currently, no standardised treatment is available for patients with persistent
      post-concussional symptoms.

      The aetiology of persistent post-concussional symptoms is only partly elicited, and no
      consensus exists whether post-concussional symptoms constitute a true syndrome linked to
      neurobiological disturbances caused by accident or head trauma. Nevertheless, the term
      post-concussional syndrome is widely used to describe a set of persistent somatic and
      emotional symptoms often observed in concussed individuals. We use the abbreviation 'PCS' as
      a purely descriptive term for post-concussional symptoms. The literature suggest, that PCS
      are best understood in a complex, multifactorial model, where both biological and
      psychological factors contribute to persistent symptoms and associated disability. Moreover,
      PCS overlap considerably with symptoms of other trauma-related conditions such as
      whiplash-associated disorders and post-traumatic stress disorder. On this background, a
      number of trials have tested the effect of various psychosocial interventions, including
      cognitive behavioural therapy (CBT), on persistent PCS. Although preliminary, there is some
      promising evidence that treatment based on the cognitive-behavioural model may be effective
      in treating PCS and prevent permanent suffering and disability.

      Some of the cognitive - behavioural mechanisms that have been found to play an important role
      in the maintenance of PCS are unhelpful illness perceptions, maladaptive coping strategies
      and all-or-nothing behaviour. The all-or-nothing behaviour refers to a behavioural response,
      where patients overdo things when they believe symptoms are abating and then spend prolonged
      periods recovering when symptoms reappear. Other patients report a gradual restriction of
      activity over time, because they fear worsening of symptoms. A promising avenue for treatment
      seems to be focusing on making sustainable, gradual increases in levels of activity (in
      intensity and / or duration) over time, and to avoid extreme oscillations. This is often
      referred to as Graded Exercise Therapy (GET), a treatment that can effectively reduce
      impairment and suffering in chronic fatigue and persistent pain and that can be provided by
      physiotherapists and hence delivered in a primary care or municipality setting.

      Currently, systematic studies of psychosocial interventions for patients with persistent PCS
      remain limited. A recent review concludes that more rigorous, large-scale randomised
      controlled trials (RCT) evaluating the effectiveness of CBT for persistent PCS are needed.

      Aim:

        1. to develop an early intervention programme based on CBT and GET principles for young
           patients aged 15 - 30 years with PCS lasting more than three months, and

        2. to evaluate the efficacy of this intervention programme on PCS in a RCT.

      Hypotheses Primary hypothesis Patients in the early intervention group will 6 months after
      randomisation report a statistically and clinically significantly greater reduction of
      post-concussional symptoms compared to patients who receive enhanced usual care.

      Secondary hypotheses

        1. Patients in the early intervention group will 6 months after randomisation report a
           statistically and clinically significantly higher health related quality of life and
           overall daily functioning compared to patients who receive enhanced usual care.

        2. Patients in the early intervention group will during the 12 months after treatment have
           less consumption of health care (based on register-data) and less illness-related
           absence from school or work (based on self-reported data) compared to patients, who
           receive enhanced usual care.
    

Intervention name(s): Enhanced Usual Care (EUC); EUC + Early intervention programme
Intervention type(s): Other; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Brain concussion; Mild Traumatic Brain Injury; Post-concussion symptoms; Therapy; Randomised controlled trial; Cognitive assessment