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

S

Shanghai Mental Health Center

Status

Completed

Conditions

Bipolar Depression

Study type

Observational

Funder types

Other

Identifiers

NCT04471454
2020-03

Details and patient eligibility

About

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.

Full 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. 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.

Enrollment

200 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

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

  • 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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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