Clinical trial NCT02690584: 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
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injuries
Post-Concussive Symptom
Post-Concussive Syndrome
Keywords: Psychotherapy
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2016-02-24
Enrollment: 16
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: symptoms assessed by Rivermead Post Concussion Symptoms Questionnaire
timeFrame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after completed therapy
Secondary outcomes:
measure: Conners CPT-III
timeFrame: 2 pre-treatment baseline measures, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
measure: D-KEFS Trail Making Test
timeFrame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
measure: Color-Word Interference Test
timeFrame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
measure: D-KEFS Verbal Fluency
timeFrame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
measure: Symbol Digit Modality Test
timeFrame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
measure: Behavior Rating Inventory-Adult version (BRIEF-A)
timeFrame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
measure: The metacognitive beliefs questionnaire (MCQ-30)
timeFrame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
measure: Fatigue questionnaire (FQ)
timeFrame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
measure: Brief Pain Inventory (BPI)
timeFrame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
measure: Inventory of Interpersonal Problems 64 (IIP-64)
timeFrame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
measure: Fatigue severity scale (FSS)
timeFrame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
measure: SF-12
timeFrame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
measure: Resilience scale for Adults (RSA)
timeFrame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
measure: Epworth sleepiness scale (ESS)
timeFrame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
measure: Insomnia severity Index (ISI)
timeFrame: baseline, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
measure: Beck Depression Inventory (BDI)
timeFrame: 3 pre-treatment baseline measures, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
measure: Beck Anxiety Inventory (BAI)
timeFrame: 3 pre-treatment baseline measures, immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
measure: Cognitive Attention Syndrome (CAS-1)
timeFrame: 3 pre-treatment baseline measures, session to session (10 sessions), immediately after last therapy session, 10 weeks after completed therapy, 6 months after therapy
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Psykologisk Institutt, Dragvoll
Study officials:
affiliation: Norwegian University of Science and Technology
name: Magne Arve Flaten, phd
role: STUDY_DIRECTOR
References: