Brain InjuriesNCT02690584
Metacognitive Therapy for Post-concussive Symptoms After Mild Traumatic Brain Injury
A study testing Metacognitive therapy in people with Brain Injuries and Post-Concussive Symptom, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Brain Injuries, Post-Concussive Symptom, Post-Concussive Syndrome
- What is being tested?
- Metacognitive therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2016to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Aged ≥between 16 and < 60 years
- Have sustained a traumatic brain injury
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Metacognitive therapy
- Keywords
- Psychotherapy
- Medical subject headings
- Brain Injuries, Post-Concussion Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metacognitive therapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Metacognitive therapy | Experimental | Metacognitive therapy, one 45-60 min session weekly during 10 weeks. Receives: Behavioral: Metacognitive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
symptoms assessed by Rivermead Post Concussion Symptoms Questionnaire
Measured: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after completed therapy
Secondary outcomes (18)
Conners CPT-III
Measured: 2 pre-treatment baseline measures, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
D-KEFS Trail Making Test
Measured: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Color-Word Interference Test
Measured: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
D-KEFS Verbal Fluency
Measured: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Symbol Digit Modality Test
Measured: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Behavior Rating Inventory-Adult version (BRIEF-A)
Measured: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
The metacognitive beliefs questionnaire (MCQ-30)
Measured: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Fatigue questionnaire (FQ)
Measured: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Brief Pain Inventory (BPI)
Measured: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Inventory of Interpersonal Problems 64 (IIP-64)
Measured: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Fatigue severity scale (FSS)
Measured: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
SF-12
Measured: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Resilience scale for Adults (RSA)
Measured: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Epworth sleepiness scale (ESS)
Measured: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Insomnia severity Index (ISI)
Measured: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Beck Depression Inventory (BDI)
Measured: 3 pre-treatment baseline measures, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Beck Anxiety Inventory (BAI)
Measured: 3 pre-treatment baseline measures, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Cognitive Attention Syndrome (CAS-1)
Measured: 3 pre-treatment baseline measures, session to session (10 sessions), immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2021
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Magne Arve Flaten, phd, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02690584
- Sponsor's protocol ID
- 2015/1456
- Status last verified
- Jul 2022
- First submitted
- 17 Feb 2016
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metacognitive Therapy for Post-concussive Symptoms After Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT02690584
- Acronym / sponsor ID
- 2015/1456
- Keywords
- Psychotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 24 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metacognitive therapy | Experimental | Behavioral: Metacognitive therapyMetacognitive therapy, one 45-60 min session weekly during 10 weeks. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Aged ≥between 16 and < 60 years
- Have sustained a traumatic brain injury
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metacognitive therapy | Behavioural | Metacognitive therapy |
Primary outcome
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
18 secondary outcomes
Conners CPT-III
Time frame: 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
Color-Word Interference Test
Time frame: 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
Symbol Digit Modality Test
Time frame: 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
The metacognitive beliefs questionnaire (MCQ-30)
Time frame: 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
Brief Pain Inventory (BPI)
Time frame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Inventory of Interpersonal Problems 64 (IIP-64)
Time frame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Fatigue severity scale (FSS)
Time frame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
SF-12
Time frame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Resilience scale for Adults (RSA)
Time frame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Epworth sleepiness scale (ESS)
Time frame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Insomnia severity Index (ISI)
Time frame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magne Arve Flaten, phd study director
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metacognitive therapy in people with Brain Injuries and Post-Concussive Symptom, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022; AzTrials last refreshed its copy on 3 Nov 2026.