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

NCT04471454 | Completed DMC

• 1 other identifier: 2020-03
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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. The purpose of this study is to verify the reliability and validity of THINC-it cognitive test in bipolar depression, and to further explore the difference of cognitive impairment between attack and remission of bipolar depression, so as to provide empirical research basis for clinical evaluation-based treatment.

Conditions

Bipolar Depression

Keywords

Bipolar Depression; cognitive impairment; THINC-it

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  Up to 1 week

• 1-back memory task (1-back)

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

  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.

  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.

  Up to 1 week

Secondary Outcomes (3)

• Sheehan Disability scale (SDS)

  Up to 8 week

• HAM-D

  Up to 8 week

• HAM-A

  Up to 8 week

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Bipolar depression group: samples were collected from outpatients and inpatients of Shanghai Mental Health Center and Shanghai Pudong New area Mental Health Center from January 2020 to December 2020, who met the diagnostic criteria of DSM-5. Healthy control group: the sample came from the social recruitment of healthy people who met the criteria of the control group and matched in sex, age and education level. 100 cases were planned to be included in the group.

You may qualify if:

• Case group:
• 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.
• \. According to DSM-5 criteria, participants were diagnosed with depressive episodes of bipolar disorder.
• \. The total score of Young's Mania scale ((YMRS)) of the participants was less than 5.
• \. Subjects received stable mood stabilizers at least two weeks before the study visit, such as SSRIs antidepressants.
• \. The combination or use of supportive psychotherapy is allowed.
• Control group:
• it did not meet any of the diagnostic criteria of axis I in DSM-5 in the past or at present.
• years old, junior high school education or above. 3.have sufficient audio-visual skills to complete the necessary examinations of the study.
• Willing to participate in this study, and the informed consent form was signed by the subjects.

You may not qualify if:

• Current alcohol and / or substance use disorders.
• Any drug that may affect cognitive function, such as psychotropic stimulants, corticosteroids, and receptor blockers.
• Benzodiazepines were used within 12 hours and alcohol consumption within 8 hours before using the THINC-it cognitive test.
• The patient has some serious physical conditions.
• The patient received electroconvulsive therapy ((ECT)) in the past 6 months.
• There are serious negative suicidal concepts and behaviors.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center IRB

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Bipolar Disorder; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Cognition Disorders; Neurocognitive Disorders

Study Officials

• Jun Chen, M.D., Ph.D

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2020
• First Posted: July 15, 2020
• Study Start: July 5, 2020
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: October 26, 2021

Record last verified: 2021-08

Locations

CN (1)