Cognitive and Psychosocial Outcome After Mild Traumatic Brain Injury

Sponsor

Shanghai 6th People's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02161172

Collaborator

(none)

360

Enrollment

Location

Duration (Months)

14.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mild Traumatic Brain Injury

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

360 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

Cognitive, Functional, and Psychosocial Outcome After Mild Traumatic Brain Injury: a Cross-sectional Study at a Tertiary Care Trauma Center.

Study Start Date :

Apr 1, 2012

Actual Primary Completion Date :

Apr 1, 2014

Actual Study Completion Date :

May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Mild traumatic brain injury Traumatic brain injury patients with Glasgow coma score (GCS) of 13-15.

Outcome Measures

Primary Outcome Measures

Mini-Mental State Examination [6 months]
MMSE includes seven factors, namely: the time orientation factor (5 points), place orientation (5 points), immediate memory (3 points), short-term memory (3 points), calculation capabilities (5 points), verbal expression, naming and repetition (4 points), speech reading and understanding (4 points), graphic depiction (1 points). The scales for the description of cognitive function impairment were grouped into three levels of education: illiteracy (17 points), primary school (20 points) and middle school (24 points). The one with score below average was considered with cognitive function impairment.

Secondary Outcome Measures

Activity of daily living scale [6 months]
The scale is divided into two parts: physical self-care ability, instrumental activities of daily living. 1 point for each option means normal; If 2~4 points for one option, he or she probably had ability decline; If two or more parts ≥3 points or total score≥ 22 points (14 questions), he or she exhibited living ability decline clearly.

Other Outcome Measures

Hospital anxiety and depression Scale [6 months]
The scale includes 14 items and each has 0-3 points. The score of the former seven items > 7, indicating depression symptom; the later seven items > 7, indicating anxiety symptom.
Symptom Check-List 90 [6 months]
This scale has been widely used to patients with neurosis, adjustment disorder and other slight mental psychological disorder. According to the national norm results, if the total score > 160, or the number of positive items > 43, or one factor score >2, we consider the positive screening.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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