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ACTIVE NOT RECRUITING
NCT04447807
NA

Metacognitive Training With Bipolar Disorder Patients.

Sponsor: University of Sao Paulo

View on ClinicalTrials.gov

Summary

The guiding question of this project is to evaluate the effectiveness of MCT as a form of ToM rehabilitation in patients diagnosed with BD who have deficits in this domain of social cognition. To do this, the work aims to be divided into three stages: (i) Evaluation of functionality through the FAST instrument (FAST score greater than or equal to 12 = mild impairment), to determine a subgroup of patients with deficits in functionality and evaluation scales for Montgomery \& Åsberg Depression Rating Scale (MADRS) and Young Mania Rating Scale (YMRS) to verify euthymia, (ii) once these inclusion aspects have been verified, a neuropsychological assessment of hot cognition variables will be carried out, (iii) finally, the sample will be randomly divided into two groups, where one group will receive structured MCT rehabilitation and the other will continue with standard pharmacological treatment (TAU).

Official title: Rehabilitating Social Cognition: A Randomized Control Study Using Metacognitive Training in a Group Format With Bipolar Disorder Patients.

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

52

Start Date

2022-02-20

Completion Date

2025-12

Last Updated

2025-03-30

Healthy Volunteers

No

Interventions

BEHAVIORAL

Metacognitive Training

MCT is a structured, interactive approach that addresses cognitive biases, social cognition, and self-esteem. This study will conducted this intervention using group format, on a weekly basis, with duration of 9 weeks total.

OTHER

Treatment as Usual

Patients will continue to receive medical attention in the Bipolar Disorder Program -PROMAN- part of the University of São Paulo Medical School.

Locations (1)

Institute of Psychiatry, Clinic Hospital University of São Paulo

São Paulo, Brazil