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

Sponsor
Shanghai Mental Health Center (Other)
Overall Status
Completed
CT.gov ID
NCT04471454
Collaborator
(none)
200
Enrollment
1
Location
14.9
Actual Duration (Months)
13.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    200 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Verification of the Reliability and Validity of THINC-it Cognitive Test in the Assessment of Cognitive Impairment in Bipolar Depression
    Actual Study Start Date :
    Jul 5, 2020
    Actual Primary Completion Date :
    Sep 30, 2021
    Actual Study Completion Date :
    Sep 30, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Composite THINC-it Tool Score [up to 8 week]

      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.

    2. CANTAB reaction time (RTI) [Up to 1 week]

      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.

    3. 1-back memory task (1-back) [Up to 1 week]

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

    4. Digit Symbol Substitution Test (DSST) [Up to 1 week]

      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.

    5. Trail Making Test B [Up to 1 week]

      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.

    Secondary Outcome Measures

    1. Sheehan Disability scale (SDS) [Up to 8 week]

      Evaluation of the severity of overall functional impairment

    2. HAM-D [Up to 8 week]

      Assess the state of depression

    3. HAM-A [Up to 8 week]

      Assessing anxiety state

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    1. According to DSM-5 criteria, participants were diagnosed with depressive episodes of bipolar disorder.

    2. The total score of Young's Mania scale ((YMRS)) of the participants was less than 5.

    3. Subjects received stable mood stabilizers at least two weeks before the study visit, such as SSRIs antidepressants.

    4. 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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Shanghai Mental Health Center IRBShanghaiShanghaiChina200030

    Sponsors and Collaborators

    • Shanghai Mental Health Center

    Investigators

    • Principal Investigator: Jun Chen, M.D., Ph.D, Shanghai Mental Health Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shanghai Mental Health Center
    ClinicalTrials.gov Identifier:
    NCT04471454
    Other Study ID Numbers:
    • 2020-03
    First Posted:
    Jul 15, 2020
    Last Update Posted:
    Oct 26, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Shanghai Mental Health Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 26, 2021