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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metacognitive therapy | Experimental | Metacognitive therapy, one 45-60 min session weekly during 10 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metacognitive therapy | Behavioral |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Conners CPT-III | 2 pre-treatment baseline measures, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy | |
| D-KEFS Trail Making Test | baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy |
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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
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
In addition to exclusion criteria already employed in the cohort study, patients with co-occurring psychiatric disorders that necessitate referral to specific treatment according to existing guidelines will be excluded from the current intervention study.
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| Name | Affiliation | Role |
|---|---|---|
| Magne Arve Flaten, phd | Norwegian University of Science and Technology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psykologisk Institutt, Dragvoll | Trondheim | Norway |
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D038223 | Post-Concussion Syndrome |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| 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 |
| Inventory of Interpersonal Problems 64 (IIP-64) | baseline, 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 |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D001924 | Brain Concussion |
| D016489 | Head Injuries, Closed |
| D014949 | Wounds, Nonpenetrating |