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

Brain Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02690584
• Other study ID #: 2015/1456
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: December 2021

Study information

• Verified date: July 2022
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Post-Concussion Syndrome
• Post-Concussive Symptom
• Post-Concussive Syndrome
• Wounds and Injuries

Intervention

Behavioral:
• Metacognitive therapy

Locations

Country	Name	City	State
Norway	Psykologisk Institutt, Dragvoll	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Conners CPT-III		2 pre-treatment baseline measures, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Secondary	D-KEFS Trail Making Test		baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Secondary	Color-Word Interference Test		baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Secondary	D-KEFS Verbal Fluency		baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Secondary	Symbol Digit Modality Test		baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Secondary	Behavior Rating Inventory-Adult version (BRIEF-A)		baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Secondary	The metacognitive beliefs questionnaire (MCQ-30)		baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Secondary	Fatigue questionnaire (FQ)		baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Secondary	Brief Pain Inventory (BPI)		baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Secondary	Inventory of Interpersonal Problems 64 (IIP-64)		baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Secondary	Fatigue severity scale (FSS)		baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Secondary	SF-12		baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Secondary	Resilience scale for Adults (RSA)		baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Secondary	Epworth sleepiness scale (ESS)		baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Secondary	Insomnia severity Index (ISI)		baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Secondary	Beck Depression Inventory (BDI)		3 pre-treatment baseline measures, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Secondary	Beck Anxiety Inventory (BAI)		3 pre-treatment baseline measures, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Secondary	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