Metacognitive Therapy for Post-concussive Symptoms After Mild Traumatic Brain Injury

Study Overview
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Brief Summary
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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.

Official Title
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Metacognitive Therapy for Post-concussive Symptoms After Mild Traumatic Brain Injury

Conditions
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Brain Injuries, Post-Concussive Symptom, Post-Concussive Syndrome

Intervention / Treatment
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* Behavioral: Metacognitive therapy


Participation Criteria
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Eligibility Criteria
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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 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 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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metacognitive therapy<br>Metacognitive therapy, one 45-60 min session weekly during 10 weeks. | Behavioral: Metacognitive therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychotherapy