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Clinical Trials in Brazil / NCT04447807
Active, not recruiting Not applicable

Metacognitive Training With Bipolar Disorder Patients.

NCT04447807 · tracked via the Priya Life Science Brazil tracker
Sponsor
University of Sao Paulo
Phase
Not applicable
Started
2022-02-20
Last updated
2025-03-30

Condition(s) studied

Bipolar Disorder

Investigational drug(s) / intervention(s)

Metacognitive TrainingTreatment as Usual

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.

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.

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria 1. Diagnosis of Bipolar Disorder Type I and Type II following the DSM-V criteria, using the Mini International Neuropsychiatric Interview (MINI) (Sheehan et al., 1998). 2. Adults between the ages of 18 and 60. 3. Both sexes. 4. FAST score greater than or equal to 12 (= mild impairment). 5. Education: Completed Elementary School, as a minimum educational criterion. 6. Estimated IQ ≥ 80. 7. Being in euthymia, assessed through scores lower than 8 on the Young Mania Rating Scale (YMRS) and/or 12 on the Montgomery-Åsberg Depression Rating Scale (MADRS). 8. Agreement to participate in the study by signing the Informed Consent Form (TCLE). Exclusion Criteria 1. Subjects with complaints of visual or auditory sensory impairment that would not allow for the administration of the tests. 2. Subjects with organic mental disorders. 3. Subjects with a history of alcohol or drug abuse in the last six months. 4. Treatment with electroconvulsive therapy in the last 12 months.

Primary outcome measure(s)

  • Theory of Mind — Baseline and Follow-up (10 weeks)
    After the intervention, the group that received the MCT intervention will present changes from baseline Theory of Mind (ToM) scores at 9 weeks, when compared to TAU group. ToM Scores is evaluated by using Reading the Mind in the Eyes Test (RMET). Reading the Mind in the Eyes Test (RMET) is evaluated by each correct response is awarded 1 point, resulting in a minimum score of 0 and a maximum score of 28. Incomplete responses are treated as incorrect, domain scores are scaled in a positive direction (i.e. higher scores denote higher theory of mind).
  • Emotion Recognition — Baseline and Follow-up (10 weeks)
    Emotion Recognition will be evaluated through the subtask of the CANTAB: Emotion Recognition Task.CANTAB Emotion Recognition Task is a computer-based cognitive assessment tool designed to measure an individual's ability to recognize emotions from facial expressions. The task presents a series of faces, each displaying a different emotional expression, and the participant is required to identify the emotion being displayed (such as happiness, sadness, anger, or fear) by selecting the appropriate label from a list of options.

Trial sites (1)

FacilityCityRegionStatus
Institute of Psychiatry, Clinic Hospital University of São Paulo São Paulo Brazil

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04447807 on ClinicalTrials.gov ↗ ← All trials in Brazil