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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Metacognitive therapy
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Injuries focused on measuring Psychotherapy

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Psykologisk Institutt, Dragvoll

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Metacognitive therapy

Arm Description

Metacognitive therapy, one 45-60 min session weekly during 10 weeks.

Outcomes

Primary Outcome Measures

symptoms assessed by Rivermead Post Concussion Symptoms Questionnaire

Secondary Outcome Measures

Conners CPT-III
D-KEFS Trail Making Test
Color-Word Interference Test
D-KEFS Verbal Fluency
Symbol Digit Modality Test
Behavior Rating Inventory-Adult version (BRIEF-A)
The metacognitive beliefs questionnaire (MCQ-30)
Fatigue questionnaire (FQ)
Brief Pain Inventory (BPI)
Inventory of Interpersonal Problems 64 (IIP-64)
Fatigue severity scale (FSS)
SF-12
Resilience scale for Adults (RSA)
Epworth sleepiness scale (ESS)
Insomnia severity Index (ISI)
Beck Depression Inventory (BDI)
Beck Anxiety Inventory (BAI)
Cognitive Attention Syndrome (CAS-1)

Full Information

First Posted
February 17, 2016
Last Updated
July 14, 2022
Sponsor
Norwegian University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT02690584
Brief Title
Metacognitive Therapy for Post-concussive Symptoms After Mild Traumatic Brain Injury
Official Title
Metacognitive Therapy for Post-concussive Symptoms After Mild Traumatic Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
December 2021 (Actual)
Study Completion Date
December 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries, Post-Concussive Symptom, Post-Concussive Syndrome
Keywords
Psychotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metacognitive therapy
Arm Type
Experimental
Arm Description
Metacognitive therapy, one 45-60 min session weekly during 10 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Metacognitive therapy
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Conners CPT-III
Time Frame
2 pre-treatment baseline measures, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Title
D-KEFS Trail Making Test
Time Frame
baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Title
Color-Word Interference Test
Time Frame
baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Title
D-KEFS Verbal Fluency
Time Frame
baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Title
Symbol Digit Modality Test
Time Frame
baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Title
Behavior Rating Inventory-Adult version (BRIEF-A)
Time Frame
baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Title
The metacognitive beliefs questionnaire (MCQ-30)
Time Frame
baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Title
Fatigue questionnaire (FQ)
Time Frame
baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Title
Brief Pain Inventory (BPI)
Time Frame
baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Title
Inventory of Interpersonal Problems 64 (IIP-64)
Time Frame
baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Title
Fatigue severity scale (FSS)
Time Frame
baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Title
SF-12
Time Frame
baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Title
Resilience scale for Adults (RSA)
Time Frame
baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Title
Epworth sleepiness scale (ESS)
Time Frame
baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Title
Insomnia severity Index (ISI)
Time Frame
baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magne Arve Flaten, phd
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
Psykologisk Institutt, Dragvoll
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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