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

NCT02337101 | Completed

• 1 other identifier: 18122014
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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:

1. 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. 2.to evaluate the efficacy of this intervention on PCS in a randomised, controlled trial.

Conditions

Brain Concussion; Post-Concussion Syndrome

Keywords

Brain concussion; Mild Traumatic Brain Injury; Post-concussion symptoms; Therapy; Randomised controlled trial; Cognitive assessment

Outcome Measures

Primary Outcomes (1)

• Severity of PCS measured by the Rivermead Post-concussion Symptoms Questionnaire (RPQ)

  Self-rated post-concussion symptoms

  At baseline (i.e. at clinical assessment) and 3,6 (primary endpoint) and 15 months after baseline.

Secondary Outcomes (10)

• 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).

  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)

  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)

  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).

  At baseline (i.e. at clinical assessment) and 3,6 (primary endpoint)and 15 months after baseline.

• Health Anxiety measured by Whitely-8 index

  At baseline (i.e. at clinical assessment) and 3,6 (primary endpoint) and 15 months after baseline.

Study Arms (2)

Enhanced Usual Care (EUC)

ACTIVE COMPARATOR

Clinical psychiatric and neurological assessment. Information and advice.

Other: Enhanced Usual Care (EUC)

EUC + Early intervention programme

EXPERIMENTAL

Clinical psychiatric and neurological assessment. Information and advice. Individually targeted treatment programme.

Behavioral: EUC + Early intervention programme

Interventions

Enhanced Usual Care (EUC) OTHER

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.

Enhanced Usual Care (EUC)

EUC + Early intervention programme BEHAVIORAL

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.

EUC + Early intervention programme

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• Age between 15 and 30 years at the time of the head trauma.
• Able to understand, speak and read Danish.
• A score of 20 or more on the Rivermead Post Concussion Symptoms Questionnaire (RPQ).

You may not qualify if:

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

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator
• Central Denmark Region: collaborator
• Regionshospitalet Hammel Neurocenter: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Related Publications (1)

• Thastum MM, Rask CU, Naess-Schmidt ET, Tuborgh A, Jensen JS, Svendsen SW, Nielsen JF, Schroder A. Novel interdisciplinary intervention, GAIN, vs. enhanced usual care to reduce high levels of post-concussion symptoms in adolescents and young adults 2-6 months post-injury: A randomised trial. EClinicalMedicine. 2019 Dec 16;17:100214. doi: 10.1016/j.eclinm.2019.11.007. eCollection 2019 Dec.

  PMID: 31891145 DERIVED

Related Links

• Homepage for the Research Clinic for Functional Disorders, Aarhus University Hospital

MeSH Terms

Conditions

Brain Concussion; Post-Concussion Syndrome

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Andreas Schröder, MD, PhD

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

• Charlotte U Rask, MD, PhD

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2015
• First Posted: January 13, 2015
• Study Start: March 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: April 1, 2019
• Last Updated: September 26, 2019

Record last verified: 2019-01

Locations

DK (1)