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

NCT02690584 | Completed

• 1 other identifier: 2015/1456
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injuries; Post-Concussive Symptom; Post-Concussive Syndrome

Keywords

Psychotherapy

Outcome Measures

Primary Outcomes (1)

• symptoms assessed by Rivermead Post Concussion Symptoms Questionnaire

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

Secondary Outcomes (18)

• Conners CPT-III

  2 pre-treatment baseline measures, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy

• D-KEFS Trail Making Test

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

• Color-Word Interference Test

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

• D-KEFS Verbal Fluency

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

• Symbol Digit Modality Test

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

Study Arms (1)

Metacognitive therapy

EXPERIMENTAL

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

Behavioral: Metacognitive therapy

Interventions

Metacognitive therapy BEHAVIORAL

Metacognitive therapy

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥between 16 and \< 60 years
• Have sustained a traumatic brain injury

You may not qualify if:

• 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

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead

Study Sites (1)

Psykologisk Institutt, Dragvoll

Trondheim, Norway

Location

MeSH Terms

Conditions

Brain Injuries; Post-Concussion Syndrome

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Brain Concussion; Head Injuries, Closed; Wounds, Nonpenetrating

Study Officials

• Magne Arve Flaten, phd

  Norwegian University of Science and Technology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2016
• First Posted: February 24, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: July 19, 2022

Record last verified: 2022-07

Locations

NO (1)