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OpenTrials
Completed

NCT Number: NCT02690584

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

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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Key information

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Psykologisk Institutt, Dragvoll

Trondheim, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Metacognitive Therapy

Behavioral

Primary outcomes

  1. 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

Secondary outcomes

  1. 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. D-KEFS Trail Making Test

    Time frame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy

  3. Color-Word Interference Test

    Time frame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy

  4. D-KEFS Verbal Fluency

    Time frame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy

  5. Symbol Digit Modality Test

    Time frame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy

  6. Behavior Rating Inventory-Adult version (BRIEF-A)

    Time frame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy

  7. The metacognitive beliefs questionnaire (MCQ-30)

    Time frame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy

  8. Fatigue questionnaire (FQ)

    Time frame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy

  9. Brief Pain Inventory (BPI)

    Time frame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy

  10. Inventory of Interpersonal Problems 64 (IIP-64)

    Time frame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy

  11. Fatigue severity scale (FSS)

    Time frame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy

  12. SF-12

    Time frame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy

  13. Resilience scale for Adults (RSA)

    Time frame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy

  14. Epworth sleepiness scale (ESS)

    Time frame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy

  15. Insomnia severity Index (ISI)

    Time frame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy

  16. 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

  17. 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

  18. 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

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Registry information

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Feb 24, 2016
Registry last updated
Jul 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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