Cognitive and Psychosocial Outcome After Mild Traumatic Brain Injury

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

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.

Study Overview

• Status: Completed
• Conditions: Mild Traumatic Brain Injury

• Study Type: Observational
• Enrollment (Actual): 360

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200233
    • Shanghai Sixth People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Mild traumatic brain injury; Traumatic brain injury patients with Glasgow coma score (GCS) of 13-15.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mini-Mental State Examination	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activity of daily living scale	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.	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital anxiety and depression Scale	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.	6 months
Symptom Check-List 90	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.	6 months

Collaborators and Investigators

• Sponsor: Shanghai 6th People's Hospital
• Investigators: Study Director: Heng-Li Tian, M.D., Ph.D., Shanghai 6th People's Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: June 10, 2014
• First Submitted That Met QC Criteria: June 10, 2014
• First Posted (Estimate): June 11, 2014

Study Record Updates

• Last Update Posted (Actual): August 11, 2020
• Last Update Submitted That Met QC Criteria: August 8, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Mild traumatic brain injury; Cognitive outcome; Psychological outcome
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: 658214