Clinical trial NCT02161172: Cognitive and Psychosocial Outcome After Mild Traumatic Brain Injury
Official title: Cognitive, Functional, and Psychosocial Outcome After Mild Traumatic Brain Injury: a Cross-sectional Study at a Tertiary Care Trauma Center.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mild Traumatic Brain Injury
Keywords: Mild traumatic brain injury
Cognitive outcome
Psychological outcome
Lead sponsor: Shanghai 6th People's Hospital
Sponsor class: OTHER
First posted: 2014-06-11
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 360 patients with mild traumatic brain injury were enrolled in this study. Their age ranged from 18 to 60 years, with mean age of 54.3 years. Types of trauma included scalp hematoma, scalp laceration, cerebral contusion, subarachnoid hemorrhage, cerebral concussion, epidural hematoma, subdural hematoma and skull fracture. Mechanisms of injury contained traffic accident, fall, industrial accident, etc. Occupation of patients included cadres, workers, farmers, individual, unemployed. Education: college or above, middle school, primary school.

Brief summary: Patients with traumatic brain injury are likely to present with cognitive, psychological, emotional and behavioral problems during different periods, all of which affect patients' life quality seriously. The aim of this study was to assess cognitive and psychosocial outcome in patients with mild traumatic brain injury, and to determine the risk factors associated with cognitive and psychological outcome. Mini-mental state examination (MMSE), activities of daily living scale (ADL), the Hospital Anxiety Depression Scale (HADS) and mental health symptom checklist (SCL-90) were used to assess the cognitive performance and psychological outcomes in 360 patients with mild traumatic brain injury. Chi-square, Fisher's exact tests and Logistic regression analysis were used to analyze the risk factors.


Eligibility criteria: Inclusion Criteria:

* 18 \~ 60 years old
* Education: primary school and above, who could understand the content of psychological test
* History of brain trauma
* No taking of antipsychotic or any other drugs affecting central nervous system before the test
* Glasgow coma score (GCS) was 13-15

Exclusion Criteria:

* History of craniocerebral injury, brain disease, mental disease
* With mental retardation
* with other serious body diseases
* History of drug and alcohol dependence
* With color-blind or color weakness
* Who had severe visual and auditory disorders after brain injury
* Who failed or failed in completing the test effectively
* With cognitive impairment caused by the damage of the unilateral frontal or bilateral lobes, or with language dysfunction caused by temporal lobe damage

Primary outcomes:
measure: Mini-Mental State Examination
timeFrame: 6 months
Secondary outcomes:
measure: Activity of daily living scale
timeFrame: 6 months
Other outcomes:
measure: Hospital anxiety and depression Scale
timeFrame: 6 months
measure: Symptom Check-List 90
timeFrame: 6 months
Locations:
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
Study officials:
affiliation: Shanghai 6th People's Hospital
name: Heng-Li Tian, M.D., Ph.D.
role: STUDY_DIRECTOR
References: