Multidisciplinary Treatment in Patients With Mild Traumatic Brain Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-01

Study Completion Date

2015-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of the study is to compare a multidisciplinary examination and follow up by rehabilitation program with a multidisciplinary examination, good advice and follow up by the family doctor.

Further on we will examine if there were differing clinical characteristics between patients who attended a planned follow-up session and those that failed to and Prognostic factors in mild traumatic brain injury patients after discharge from hospital.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy of Multidimensional Management of Mild Traumatic Brain Injury

NCT03811626

Mild Traumatic Brain Injury

COMPLETED NA

Interdisciplinary Interventions After mTBI

NCT06815692

Concussion, Mild

NOT_YET_RECRUITING

Multicenter Early Intervention Study in Adults With Complaints After Mild Traumatic Brain Injury

NCT07341074

Mild Traumatic Brain Injury

NOT_YET_RECRUITING NA

Vestibular Rehabilitation and Balance Training After Traumatic Brain Injury

NCT01695577

Traumatic Brain Injury Brain Concussion Head Injury +1 more

COMPLETED NA

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

NCT02690584

Brain Injuries Post-Concussive Symptom Post-Concussive Syndrome

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

2 months after an acute mild traumatic brain injury (TBI) defined as Glasgow Coma Scale between 13 and 15. The patient will get a clinical examination by a specialist in rehabilitation medicine. Patient who wish or need a further follow up, are out of work or school, will be included and randomized to either a multidisciplinary follow up or primary care follow by their family doctor.

Both groups will got a multidisciplinary examination. The multidisciplinary team will work out a rehabilitation program and a report back to their family doctor.

Patient who got a multidisciplinary follow up will then get individual appointments and they will follow an educational program for 4 days. The topics are physical and psychical problems after TBI and problems in daily living and return to work. We will teach a way to accept and deal with their problems. A cognitive behavioural treatment or a psycho educative approach will be central in the treatment. The follow up period will be until 2 years if needed.

For booth groups we will make a registration of sick leave for 5 years. The Extended Glasgow Outcome Scale (GOS- E), Hospital Anxiety and Depression Scale (HAD), Rivermead post concussion symptoms questionnaire and Patient Global Impression of Change (PGIC) after 6 and 12 months.

Department of Economics at the University of Bergen will make cost-benefit analysis.

Further on we will examine if there were differing clinical characteristics between patients who attended a planned follow-up session and those that failed to, if sick leave or return to work could make a difference and Prognostic factors in mild traumatic brain injury patients after discharge from hospital. We also include demographic data, CT findings and clinical data based on information from the medical records, pain drawings and numeric rating scale for pain, Quality of Life and Subjective Health Complaints inventory. We got data about days on sick leave, diagnosis for sick leave and income for the first year before and after the injury from The Norwegian Labour and Welfare Service (NAV) through a third accredited agency Statistics Norway. From Statistics Norway we got additional information about education level and income.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Traumatic Brain Injury With Brief Loss of Consciousness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial. Multidisciplinary outpatient rehabilitation with individual contacts and a psycho-educational group intervention at two outpatient rehabilitation clinics compared to follow-up by a general practitioner after a multidisciplinary examination.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

The baseline data were collected before randomization. The data collection at 12 months was conducted by postal self-report questionnaires, and for GOSE, an assistant who was blinded to the group allocation performed a telephone interview. Two independent persons, who were blinded for the groups and were unfamiliar with the aim and content of the study, entered the data into the SPSS database. A statistician, who did not participate in the treatment program and was blinded to the group allocation when the data were analyzed, controlled the data and performed the statistical analyses for RTW and the secondary outcomes.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Primary care follow up

Multidisciplinary examination and follow up by the family doctor.

Group Type ACTIVE_COMPARATOR

primary care follow up

Intervention Type BEHAVIORAL

Multidisciplinary examination, good advice from rehabilitation specialists and follow up by the family doctor.

Multidisciplinary follow up

Multidisciplinary examination and follow up by a multidisciplinary outpatient team.

Group Type EXPERIMENTAL

Multidisciplinary follow up

Intervention Type BEHAVIORAL

Multidisciplinary examination and follow up by rehabilitation specialists, a multidisciplinary team following an individual rehabilitation programs.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

primary care follow up

Multidisciplinary examination, good advice from rehabilitation specialists and follow up by the family doctor.

Intervention Type BEHAVIORAL

Multidisciplinary follow up

Multidisciplinary examination and follow up by rehabilitation specialists, a multidisciplinary team following an individual rehabilitation programs.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Bergen Mild Traumatic Brain Injury Study. Bergen Mild Traumatic Brain Injury Study

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patient admitted acute to Department of Neurosurgery ICD-10 diagnosed S06.0- S06.9
* Age 16 to 55 years
* Mild traumatic brain injury defined as Glasgow Coma Scale (GCS) between 13 and 15.

Exclusion Criteria

* Earlier severe traumatic brain injury (GCS 8 or less).
* Serious psychiatric disease (ICD-10 diagnosed last two years).
* Known drug abuse (ICD-10 diagnosed last two years).
* Other serious illness which have a major impact of the outcome.
* Social client last two years as major income

Minimum Eligible Age

16 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No