- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02690584
Metacognitive Therapy for Post-concussive Symptoms After Mild Traumatic Brain Injury
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Trondheim, Norway
- Psykologisk Institutt, Dragvoll
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Metacognitive therapy
Metacognitive therapy, one 45-60 min session weekly during 10 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
symptoms assessed by Rivermead Post Concussion Symptoms Questionnaire
Time Frame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after completed therapy
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baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after completed therapy
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Conners CPT-III
Time Frame: 2 pre-treatment baseline measures, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
|
2 pre-treatment baseline measures, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
|
D-KEFS Trail Making Test
Time Frame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
|
baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
|
Color-Word Interference Test
Time Frame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
|
baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
|
D-KEFS Verbal Fluency
Time Frame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
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baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
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Symbol Digit Modality Test
Time Frame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
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baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
|
Behavior Rating Inventory-Adult version (BRIEF-A)
Time Frame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
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baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
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The metacognitive beliefs questionnaire (MCQ-30)
Time Frame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
|
baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
|
Fatigue questionnaire (FQ)
Time Frame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
|
baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
|
Brief Pain Inventory (BPI)
Time Frame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
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baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
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Inventory of Interpersonal Problems 64 (IIP-64)
Time Frame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
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baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
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Fatigue severity scale (FSS)
Time Frame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
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baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
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SF-12
Time Frame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
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baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
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Resilience scale for Adults (RSA)
Time Frame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
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baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
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Epworth sleepiness scale (ESS)
Time Frame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
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baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
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Insomnia severity Index (ISI)
Time Frame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
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baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
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Beck Depression Inventory (BDI)
Time Frame: 3 pre-treatment baseline measures, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
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3 pre-treatment baseline measures, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
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Beck Anxiety Inventory (BAI)
Time Frame: 3 pre-treatment baseline measures, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
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3 pre-treatment baseline measures, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
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Cognitive Attention Syndrome (CAS-1)
Time Frame: 3 pre-treatment baseline measures, session to session (10 sessions), immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
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3 pre-treatment baseline measures, session to session (10 sessions), immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
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Collaborators and Investigators
Investigators
- Study Director: Magne Arve Flaten, phd, Norwegian University of Science and Technology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015/1456
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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