Brain Injuries, Post-Concussive Symptom, Post-Concussive Syndrome
Conditions
Keywords
Psychotherapy
Brief summary
The purpose of this open trial is to investigate the feasibility, acceptability, and effect of metacognitive therapy in patients with prolonged post-concussive symptoms after mild traumatic brain injury.
Interventions
BEHAVIORALMetacognitive therapy
Sponsors
Norwegian University of Science and Technology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Patients with prolonged recovery after mild TBI (GCS \>12) will be recruited to our study if they have post concussive symptoms \> 6 months after injury. Patients will be recruited from an ongoing cohort study investigating mild and moderate TBI at St. Olavs Hospital and Trondheim Municipality Emergency Clinic, and in addition (as of October 2017) among TBI patients at St Olavs Hospital who were not included in the cohort study. Inclusion criteria * Aged ≥between 16 and \< 60 years * Have sustained a traumatic brain injury
Exclusion criteria
* Severe TBI (GCS score 8 or less) * Non fluency in Norwegian * Living outside of Norway * Major other trauma with high risk of disability lasting more than 3 months. * Major incidental intracranial findings in acute MRI e.g. cyst, tumor, malformation, infarctions. * Severe psychiatric, neurological or medical disease, including: Psychotic disorders, bipolar disorder, ongoing severe depressive episode * Personality disorders affecting adherence to the research protocol * Alcohol/drug abuse affecting adherence to the research protocol * Mental retardation, autism or other severe developmental disorders * Prior complicated mild, moderate or severe TBI * Stroke or other acquired brain injuries * Progressive neurological disorders (e.g. Parkinson's disease, MS) * Advanced cancer, heart- or respiratory disease or other somatic diseases that interfere with function. * Major other trauma e.g. spinal cord injury In addition to
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| symptoms assessed by Rivermead Post Concussion Symptoms Questionnaire | baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after completed therapy |
Secondary
| Measure | Time frame |
|---|---|
| D-KEFS Trail Making Test | baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy |
| Color-Word Interference Test | baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy |
| D-KEFS Verbal Fluency | baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy |
| Symbol Digit Modality Test | baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy |
| Behavior Rating Inventory-Adult version (BRIEF-A) | baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy |
| The metacognitive beliefs questionnaire (MCQ-30) | baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy |
| Fatigue questionnaire (FQ) | baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy |
| Brief Pain Inventory (BPI) | baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy |
| Conners CPT-III | 2 pre-treatment baseline measures, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy |
| Fatigue severity scale (FSS) | baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy |
| SF-12 | baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy |
| Resilience scale for Adults (RSA) | baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy |
| Epworth sleepiness scale (ESS) | baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy |
| Insomnia severity Index (ISI) | baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy |
| Beck Depression Inventory (BDI) | 3 pre-treatment baseline measures, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy |
| Beck Anxiety Inventory (BAI) | 3 pre-treatment baseline measures, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy |
| Cognitive Attention Syndrome (CAS-1) | 3 pre-treatment baseline measures, session to session (10 sessions), immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy |
| Inventory of Interpersonal Problems 64 (IIP-64) | baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy |
Countries
Norway
Outcome results
None listed