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NCT Number: NCT02161172

Cognitive and Psychosocial Outcome After Mild Traumatic Brain Injury

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Sixth People's Hospital

Shanghai, 200233, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Mini-Mental State Examination

    Time frame: 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 outcomes

  1. Activity of daily living scale

    Time frame: 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 outcomes

  1. Hospital anxiety and depression Scale

    Time frame: 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.

  2. Symptom Check-List 90

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Shanghai 6th People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 11, 2014
Registry last updated
Aug 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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