Metacognitive Training With Bipolar Disorder Patients.

NCT04447807 | Active Not Recruiting

• 2 other identifiers: 40405513148742040000068
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Bipolar Disorder

Keywords

Bipolar Disorder; Theory of Mind; Social Cognition; Metacognitive Training; Cognitive Rehabilitation; Cognitive Impairment

Outcome Measures

Primary Outcomes (2)

• Theory of Mind

  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).

  Baseline and Follow-up (10 weeks)

• Emotion Recognition

  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.

  Baseline and Follow-up (10 weeks)

Secondary Outcomes (4)

• Functioning Outcome

  Baseline and Follow-up (10 weeks)

• Neuropsychological outcome

  Baseline and Follow-up (10 weeks)

• Quality of Life outcome

  Baseline and Follow-up (10 weeks)

• Mood outcome measures

  Baseline and Follow-up (10 weeks)

Study Arms (2)

Group A: Metacognitive Training Intervention

EXPERIMENTAL

Participants of this group will undergo Metacognitive Training (MCT) in group format for the duration of 9 weeks. The intervention will be held once a week, with an estimated duration of 1-2 hours. The MCT intervention focuses on rehabilitating Social Cognition and teaching skills of interpersonal relations, as well as functional remediation aspects. We estimate a total of 26 participants in this group.

Behavioral: Metacognitive Training

Group B: Treatment as Usual

EXPERIMENTAL

Participants of this group will continue to receive medical attention in the Bipolar Disorder Program -PROMAN- part of the University of São Paulo Medical School, although they will not be part taking in any group rehabilitation format We estimate a total of 26 participants in this group.

Other: Treatment as Usual

Interventions

Metacognitive Training BEHAVIORAL

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.

Also known as: MCT

Group A: Metacognitive Training Intervention

Treatment as Usual OTHER

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

Also known as: TAU

Group B: Treatment as Usual

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).
• Adults between the ages of 18 and 60.
• Both sexes.
• FAST score greater than or equal to 12 (= mild impairment).
• Education: Completed Elementary School, as a minimum educational criterion.
• Estimated IQ ≥ 80.
• 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).
• Agreement to participate in the study by signing the Informed Consent Form (TCLE).

You may not qualify if:

• Subjects with complaints of visual or auditory sensory impairment that would not allow for the administration of the tests.
• Subjects with organic mental disorders.
• Subjects with a history of alcohol or drug abuse in the last six months.
• Treatment with electroconvulsive therapy in the last 12 months.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Institute of Psychiatry, Clinic Hospital University of São Paulo

São Paulo, 05403-903, Brazil

Location

MeSH Terms

Conditions

Bipolar Disorder; Cognitive Dysfunction

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Cognition Disorders; Neurocognitive Disorders

Study Officials

• Beny Lafer

  Associate Professor of the Department of Psychiatry, USP

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of the Department of Psychiatry (IPq), University of São Paulo Medical School

Model Details: Patients eligible for this study will be randomized into two groups: Metacognitive Training Intervention (9 weeks) or Treatment as Usual (9 weeks).

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: June 25, 2020
• Study Start: February 20, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)