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

September 25, 2019 updated by: University of Aarhus

Early Intervention Programme for Impairing Post-concussional Symptoms in Adolescents and Young Adults: Randomised Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8200
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Concussion caused by a head trauma according to the diagnostic criteria recommended by the Danish Consensus Report on Commotio Cerebri 5 within the last 2 - 6 months. The criteria is based on the diagnostic criteria recommended by the WHO Task Force 1, but with the amendment, that there must have been a direct contact between the head and an object in order to rule out acceleration - deceleration traumas.
  2. Age between 15 and 30 years at the time of the head trauma.
  3. Able to understand, speak and read Danish.
  4. A score of 20 or more on the Rivermead Post Concussion Symptoms Questionnaire (RPQ).

Exclusion Criteria:

  1. Objective neurological findings from neurological examination and / or acute trauma CT scan, indicating neurological disease or brain damage.
  2. Previous concussion leading to persistent post-concussional symptoms within the last two years.
  3. Severe misuse of alcohol, prescription drugs and / or illegal drugs.
  4. Multiorgan Bodily Distress Syndrome (multiple somatic symptoms from various body sites and organ systems not related to the accident).
  5. Psychiatric morbidity (Bipolar Disorder, severe Attention Deficit Hyperactivity Disorder, autism, psychotic disorder (life time)), or other psychiatric illness that impedes participation in the treatment.
  6. Severe neurological disease and / or other medical disease that impedes participation in the treatment programme.
  7. Significant learning and / or reading difficulties or mental retardation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Enhanced Usual Care (EUC)
Clinical psychiatric and neurological assessment. Information and advice.
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.
Experimental: EUC + Early intervention programme
Clinical psychiatric and neurological assessment. Information and advice. Individually targeted treatment programme.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Self-rated post-concussion symptoms
At baseline (i.e. at clinical assessment) and 3,6 (primary endpoint) and 15 months after baseline.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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.
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.
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)
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).
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
At baseline (i.e. at clinical assessment) and 3,6 (primary endpoint) and 15 months after baseline.
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
At baseline (i.e. at clinical assessment) and 3,6 and 15 months after baseline.
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
At baseline (i.e. at clinical assessment) and 3,6 (primary endpoint) and 15 months after baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Aarhus

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Aarhus University Hospital
Central Denmark Region
Regionshospitalet Hammel Neurocenter

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andreas Schröder, MD, PhD, Aarhus University Hospital
  • Principal Investigator: Charlotte U Rask, MD, PhD, Aarhus University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 8, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 13, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 26, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Keywords

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Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18122014

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