Clinical Trial: Early Intervention Programme for Young Patients (Aged 15 - 30 Years) With Symptoms Following Concussion.
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Early Intervention Programme for Impairing Post-concussional Symptoms in Adolescents and Young Adults: Randomised Trial
Brief 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:
- 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
- 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 Summary:
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, i
Sponsor: University of Aarhus
Current Primary Outcome: Severity of PCS measured by the Rivermead Post-concussion Symptoms Questionnaire (RPQ) [ Time Frame: At baseline (i.e. at clinical assessment) and 3,6 (primary endpoint) and 15 months after baseline. ]
Original Primary Outcome: Severity of PCS measured by the Rivermead Post-concussion Symptoms Questionnaire (RPQ) [ Time Frame: At baseline (i.e. at clinical assessment) and 3,6 (primary endpont) and 15 months after baseline. ]
Current Secondary Outcome:
- Quality of life and overall functioning measured by Quality of Life After Brain Injury - Overall Scale (QOLIBRI) and Short Form health status questionnaire from the medical outcome status (SF-36). [ Time Frame: At baseline (i.e. at clinical assessment) and 3,6 (primary endpoint) and 15 months after baseline. ]
- Subjective improvement measured by Patient Global Impression of Change (PGIC) [ Time Frame: At baseline (i.e. at clinical assessment) and 3,6 (primary endpoint) and 15 months after baseline. ]
- Somatisation measured by Bodily Distress Syndrome Checklist (BDS checklist) [ Time Frame: At baseline (i.e. at clinical assessment) and 3,6 (primary endpoint) and 15 months after baseline. ]
- Anxiety and depression severity measured by a subscale (SCL-8) of Symptom Check List, 90 items (SCL-90). [ Time Frame: At baseline (i.e. at clinical assessment) and 3,6 (primary endpoint)and 15 months after baseline. ]
- Health Anxiety measured by Whitely-8 index [ Time Frame: At baseline (i.e. at clinical assessment) and 3,6 (primary endpoint) and 15 months after baseline. ]
- Consumption of health care (extracted from Danish national registers) and degree of illness related absence from school or work (self-reported). [ Time Frame: 15 months after baseline (i.e. after clinical assessment) ]
- Self-reported cognitive functioning measured by Behavior Rating Inventory of Executive Function (BRIEF) [ Time Frame: At baseline (i.e. at clinical assessment) and 6 months after baseline (primary endpoint). ]
- Change in illness related cognitions measured by The Brief Illness Perception Questionnaire (B-IPQ) [ Time Frame: At baseline (i.e. at clinical assessment) and 3,6 (primary endpoint) and 15 months after baseline. ]Process measure
- Change in illness-related behaviours measured by the Behavioural Responses to Illness Questionnaire - short form (BRIQ - short form) [ Time Frame: At baseline (i.e. at clinical assessment) and 3,6 and 15 months after baseline. ]Process measure
- Change in perceived stress measured by Perceived Stress Scale (PSS) [ Time Frame: At baseline (i.e. at clinical assessment) and 3,6 (primary endpoint) and 15 months after baseline. ]Process measure
Original Secondary Outcome: Same as current
Information By: University of Aarhus
Dates:
Date Received: January 8, 2015
Date Started: March 2015
Date Completion: March 2018
Last Updated: June 10, 2016
Last Verified: June 2016
