Verification of the Reliability and Validity of THINC-it Tool in Bipolar Depression

Shanghai Mental Health Center200 enrolled

Overview

There is some cognitive impairment in patients with bipolar depression. THINC-it is a simple, fast and free cognitive assessment tool. It has good reliability and validity in patients with depression, but its application in patients with bipolar depression is not clear. This study includes three steps. 1. baseline: demographic data, sequential test THINC-it and standard test tools, clinical scale evaluation, to verify the discriminant validity and parallel validity of THINC-it in bipolar depression. 2. follow-up (1 week): 30-50 patients with stable bipolar depression were evaluated by clinical scale and THINC-it test to verify the test-retest reliability of THINC-it in bipolar depression. 3. follow-up (8 weeks): all patients with bipolar depression were evaluated by clinical scale, THINC-it test, longitudinal comparison data, and the influencing factors of cognitive impairment were analyzed.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Bipolar Depression

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Case group: 1. Participants in psychiatric outpatients and inpatients are able and willing to provide informed consent. two。. The participants were male or female aged between 18 and 65, with junior high school education or above. 3\. According to DSM-5 criteria, participants were diagnosed with depressive episodes of bipolar disorder. 4\. The total score of Young's Mania scale ((YMRS)) of the participants was less than 5. 5\. Subjects received stable mood stabilizers at least two weeks before the study visit, such as SSRIs antidepressants. 6\. The combination or use of supportive psychotherapy is allowed. Control group: 1.it did not meet any of the diagnostic criteria of axis I in DSM-5 in the past or at present. 2.18-65 years old, junior high school education or above. 3.have sufficient audio-visual skills to complete the necessary examinations of the study. 4.Willing to participate in this study, and the informed consent form was signed by the subjects. Exclusion Criteria: 1. Current alcohol and / or substance use disorders. 2. Any drug that may affect cognitive function, such as psychotropic stimulants, corticosteroids, and receptor blockers. 3. Benzodiazepines were used within 12 hours and alcohol consumption within 8 hours before using the THINC-it cognitive test. 4. The patient has some serious physical conditions. 5. The patient received electroconvulsive therapy ((ECT)) in the past 6 months. 6. There are serious negative suicidal concepts and behaviors.

Locations (1)

Shanghai Mental Health Center IRB

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Composite THINC-it Tool Score

The composite THINC-it tool score is the integrated total score of results from performance on five sub-component cognitive tests of the THINC-it tool.

Time frame: up to 8 week

CANTAB reaction time (RTI)

online computer test, RTI evaluates the response speed of movement and psychology, as well as activity time, reaction time, accurate value and error value of response, and calculates the time required to correctly evaluate the occurrence of stimuli in one location.

Time frame: Up to 1 week

1-back memory task (1-back)

the subjects' attention, memory, reaction speed and executive function were tested.

Time frame: Up to 1 week

Digit Symbol Substitution Test (DSST)

participants in the digital symbol substitution test calculated the correct total number by matching symbols and numbers as soon as possible within 90 seconds according to the coding table.

Time frame: Up to 1 week

Trail Making Test B

he subjects calculated the completion time according to the cross-connection of numbers and letters. The higher the score, the more obvious the functional damage.

Time frame: Up to 1 week

Secondary Outcomes

Sheehan Disability scale (SDS)

Evaluation of the severity of overall functional impairment

Time frame: Up to 8 week

HAM-D

Assess the state of depression

Time frame: Up to 8 week

Data from ClinicalTrials.gov

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