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

Bipolar Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04471454
• Other study ID #: 2020-03
• Status: Completed
• Start date: July 5, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: August 2021
• Source: Shanghai Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder

Locations

Country	Name	City	State
China	Shanghai Mental Health Center IRB	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite THINC-it Tool Score	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.	up to 8 week
Primary	CANTAB reaction time (RTI)	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.	Up to 1 week
Primary	1-back memory task (1-back)	the subjects' attention, memory, reaction speed and executive function were tested.	Up to 1 week
Primary	Digit Symbol Substitution Test (DSST)	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.	Up to 1 week
Primary	Trail Making Test B	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.	Up to 1 week
Secondary	Sheehan Disability scale (SDS)	Evaluation of the severity of overall functional impairment	Up to 8 week
Secondary	HAM-D	Assess the state of depression	Up to 8 week
Secondary	HAM-A	Assessing anxiety state	Up to 8 week