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

Completed

• Conditions: Bipolar Depression

• Registration Number: NCT04471454
• Lead Sponsor: Shanghai Mental Health Center

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.

Study Timeline

• Study Start: 2020-07-05
• Study First Submitted: 2020-07-12
• Study First Submitted QC: 2020-07-12
• Study First Posted: 2020-07-15
• Status Verified: 2021-08
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Last Update Submitted: 2021-10-24
• Last Update Posted: 2021-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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.
1-back memory task (1-back)	Up to 1 week	the subjects' attention, memory, reaction speed and executive function were tested.
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.
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

Name	Time	Method
HAM-D	Up to 8 week	Assess the state of depression
HAM-A	Up to 8 week	Assessing anxiety state
Sheehan Disability scale (SDS)	Up to 8 week	Evaluation of the severity of overall functional impairment

Trial Locations

Locations (1)

Shanghai Mental Health Center IRB; 🇨🇳 Shanghai, Shanghai, China