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Completed

NCT Number: NCT04471454

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Mental Health Center IRB

Shanghai, Shanghai Municipality, 200030, China

About this study

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.

  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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:

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

  • 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.

Treatment and study plan

Primary outcomes

  1. Composite THINC-it Tool Score

    Time frame: 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)

    Time frame: 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)

    Time frame: Up to 1 week

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

  4. Digit Symbol Substitution Test (DSST)

    Time frame: 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

    Time frame: 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 outcomes

  1. Sheehan Disability scale (SDS)

    Time frame: Up to 8 week

    Evaluation of the severity of overall functional impairment

  2. HAM-D

    Time frame: Up to 8 week

    Assess the state of depression

  3. HAM-A

    Time frame: Up to 8 week

    Assessing anxiety state

Sponsors and collaborators

Lead sponsor

Shanghai Mental Health Center

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 15, 2020
Registry last updated
Oct 26, 2021

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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