Persistent post-concussive complaints following mild traumatic brain injury. Nervous System Diseases Persistent post-concussive complaints following mild traumatic brain injury.
Conditions
Interventions
Patients who have given consent to participate are randomly assigned the early intervention or control treatment. by drawing a lot from an envelope containing 20 lots are put (10 CBT, 10 control) by a
Sponsors
Hersenstichting Nederland (Dutch Brain Foundation)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Mild traumatic brain injury (mTBI) patients admitted to the emergency departments (ED’s) of the participating centers 2. Age between 18 and 65 years 3. Normal admission CT scan 4. In paid work or studying at the time of injury 5. Patients at-risk for persistent post-concussive complaints are selected for enrollment in the intervention, starting within 4-6 weeks post-trauma. At-risk status was based on the score on the Head Injury Symptom Checklist (HISC), which comprises of 16 complaints commonly described after TBI with premorbid levels, using values from 0 to 2 (0= never, 1= sometimes, 2= often). Eligible patients must report three or more complaints of which at least one should be in the cognitive or in the emotional domain.
Exclusion criteria
Exclusion criteria: 1. Chronic alcohol and/or drug abuse 2. Major psychiatric or neurological disorders 3. Without comprehension of Dutch language 4. Without a permanent home address
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Level of resumption of work is measured using the RTW scale at 6 and 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Working status, defined as total days off work at 12 months, is measured by a questionnaire at 12 months 2. Functional outcome is measured using the Extended Glasgow Outcome Scale (GOS-E), determined at 6 and 12 months 3. Trauma related complaints are measured using the Head Injury Symptom Checklist (HISC), Dutch version of the Rivermead Postconcussion Questionnaire at 2 weeks, 3, 6, and 12 months 4. Physical and mental complaints are measured using the Symptoms Checklist (SCL-90 revised) at 6 and 12 months 5. Mood is measured using the Hospital Anxiety and Depression scale (HADS) at 2 weeks, 3, 6, and 12 months 6. Impact of Event is measured using the DSM criteria PTSS-List and Centrality of Event List-short at 2 weeks, 6 and 12 months 7. Coping is measured using the Utrechtse Copinglist (UCL) at 2 weeks, 3, 6 and 12 months 8. Fatigue is measured using the Dutch Multidimensional Fatigue Scale at 12 months 9. Self-efficacy is measured using the Dutch General Self-Efficacy Scale (DGSES) at 6 and 12 months 10. Executive dysfunction is measured using the Dysexecutive Questionnaire (DEX) at 6 and 12 months | — |
Countries
Netherlands
Outcome results
None listed