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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Trondheim, Norway
        • Psykologisk Institutt, Dragvoll

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 63 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.

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

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
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
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
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
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
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
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
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
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
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
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
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
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
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
3 pre-treatment baseline measures, session to session (10 sessions), immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Magne Arve Flaten, phd, Norwegian University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

February 17, 2016

First Submitted That Met QC Criteria

February 19, 2016

First Posted (Estimate)

February 24, 2016

Study Record Updates

Last Update Posted (Actual)

July 19, 2022

Last Update Submitted That Met QC Criteria

July 14, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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