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

Verification of the Reliability and Validity of THINC-it Cognitive Test in the Assessment of Cognitive Impairment in Bipolar Depression

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04471454
Enrollment
200
Registered
2020-07-15
Start date
2020-07-05
Completion date
2021-09-30
Last updated
2021-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Depression

Keywords

Bipolar Depression, cognitive impairment, THINC-it

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.

Detailed description

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.

Interventions

None listed

Sponsors

Shanghai Mental Health Center
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Trail Making Test BUp to 1 weekhe subjects calculated the completion time according to the cross-connection of numbers and letters. The higher the score, the more obvious the functional damage.
CANTAB reaction time (RTI)Up to 1 weekonline 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.
1-back memory task (1-back)Up to 1 weekthe subjects' attention, memory, reaction speed and executive function were tested.
Digit Symbol Substitution Test (DSST)Up to 1 weekparticipants 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.
Composite THINC-it Tool Scoreup to 8 weekThe 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.

Secondary

MeasureTime frameDescription
HAM-DUp to 8 weekAssess the state of depression
HAM-AUp to 8 weekAssessing anxiety state
Sheehan Disability scale (SDS)Up to 8 weekEvaluation of the severity of overall functional impairment

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026