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

Norwegian University of Science and Technology1 site in 1 country16 target enrollmentMarch 2016

ConditionsBrain Injuries Post-Concussive Symptom Post-Concussive Syndrome

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Brain Injuries
Sponsor: Norwegian University of Science and Technology
Enrollment: 16
Locations: 1
Primary Endpoint: symptoms assessed by Rivermead Post Concussion Symptoms Questionnaire
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2016

End Date

December 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Norwegian University of Science and Technology

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

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

Symbol Digit Modality Test(baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy)
Resilience scale for Adults (RSA)(baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy)
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)
Behavior Rating Inventory-Adult version (BRIEF-A)(baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy)
The metacognitive beliefs questionnaire (MCQ-30)(baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy)
Fatigue questionnaire (FQ)(baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy)
Brief Pain Inventory (BPI)(baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy)
Inventory of Interpersonal Problems 64 (IIP-64)(baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy)
Fatigue severity scale (FSS)(baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy)
SF-12(baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy)
Epworth sleepiness scale (ESS)(baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy)
Cognitive Attention Syndrome (CAS-1)(3 pre-treatment baseline measures, session to session (10 sessions), immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy)
Insomnia severity Index (ISI)(baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy)
Beck Depression Inventory (BDI)(3 pre-treatment baseline measures, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy)
Beck Anxiety Inventory (BAI)(3 pre-treatment baseline measures, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy)