Metacognitive Training With Bipolar Disorder Patients.

  • STATUS
    Recruiting
  • End date
    Dec 28, 2023
  • participants needed
    90
  • sponsor
    University of Sao Paulo
Updated on 28 May 2022
depression
depressed mood
mania
euthymia

Summary

The aim of this research project is to evaluate the efficacy of Metacognitive Training (MCT) as a form of rehabilitating Theory of Mind (ToM) deficits in patients with Bipolar Disorder (BD) diagnosis, as well as, rehabilitation of deficits in Social Cognition. Therefore, this research is divided in two main steps: The first being a Neuropsychological Evaluation of ToM in order to determine a subgroup of patients that display ToM deficits. The following step would be the MCT as a rehabilitation intervention with the ToM deficits subgroup vs a TAU group, in order to evaluate this novel training capacity in improving ToM and Social Cognition.

Description

Problem Statement: The present study will focus on the importance of understanding on a theoretical and practical level the importance of interventions that focus on Social Cognition rehabilitation, specifically ToM regarding people with BD diagnosis. ToM is an essential component for social harmony and as consequence, deficits in this order might lead to serious problems in interpersonal relations.

Current interventions that focus on the rehabilitation of BD in a group format target mainly only cold cognition aspects, with the exception of a small number of sessions that approach social cognitive deficits. BD is a heterogeneous disorder when it comes to cognitive deficits thus, requires a more "personalized medicine", considering individual specifics.

With this in mind, our intervention proposes a specific focus on rehabilitating Social Cognition, with ToM being the focal point. To this present moment, these explicit areas and a possible MCT intervention have not been evaluated in a randomized controlled trial with the BD population.

Purpose of the Study

Main Purpose: Evaluate the efficacy of the MCT intervention by means of a randomized controlled trial with patients that have been diagnosed with BD, current mood state of euthymia and that present ToM deficits.

Specific Purpose:Evaluate, analyze and demonstrated using neuropsychological evaluation qualitive and quantitive aspects of ToM in BD patients in a descriptive analytic study. Compare the MCT approach with Treatment as Usual (TAU), evaluating: ToM functioning, social cognition functioning, cognitive domain functioning and quality of life and functionality improvement.

Outcomes

Main Outcomes: After the intervention, the group that received the MCT intervention will present a lower deficit in ToM tasks when compared to TAU group.

Secondary Outcomes:

  1. After the intervention, the group that received the MCT intervention will present a better performance in Social Cognition tests, present in CANTAB, when compared to the TAU group.
  2. After 12 months, patients that participated in the MCT group will exhibit higher scores of quality of life and lower scores in FAST, indicating a better functionality.
  3. After 12 months, patients that participated in MCT group will exhibit a better performance in cognitive tasks related to ToM and Social Cognition, when compared with TAU group.

Methodology: All participants will be recruited from our current pool of patients that receive medical attention in the Bipolar Disorder Program (PROMAN); part of the University of São Paulo Medical School. All participants will have access to their Informed Consent Form and those who agree with the terms will be part of the study. This study's main aim is to evaluate the efficacy of the MCT intervention, with specific focus on ToM. Therefore, our research design in divided in two levels: 01) Neuropsychological Evaluation of Cognition and ToM and 02) Intervention MCT vs TAU.Therefore, in order to precede to level 02 (Intervention), patients must present ToM deficits. Patients who do not qualify will not continue to the intervention, given they present no need for a rehabilitation in ToM and Social Cognition.

Instrumentation: All evaluators (for the application of tests and main interviews) will remain blind during the intervention. The instruments that will be used in this research are the following:

  • Montomery&Asberg Scale for Depression(MADRS)
  • Young Scale for Mania
  • Scale of Quality of Life (WHOQoL- bref)
  • Scale for Functionality(FAST)
  • Neuropsychological Evaluation: Cambridge Automated Neuropsychological Test Automated Battery (CANTAB): Evaluates cold and hot cognitive domains).
  • ToM evaluation: Reading in the Mind Eyes Test(RMET) and Faux Pas Recognition Test.

Data collection and Analysis Procedure: All patients that apply to the mentioned criteria and that accept to partake in this research will be evaluated with the CANTAB for the Neuropsychological Evaluation and ToM evaluation. Those who present ToM deficits will continue in the next step of our research, in which the sample will be randomized into two groups: The MCT interventions group vs. the TAU group. We estimate a number of 45 patients for each arm of this trial. The MCT intervention format is based on recent literature by Haffner, 2017, and is 8 weeks long, with weekly encounters. The amount of medication and number of medical consultations will not be limited in this study, with the purpose of being as ecological as possible to real clinical situation. However, such variables will be observed later on through access to medical records.The CANTAB evaluation and ToM evaluation will be applied to all participants, before and after the group intervention, as well as after 12 months since the first group.

Details
Condition Bipolar Disorder
Treatment Treatment As Usual, Metacognitive Training
Clinical Study IdentifierNCT04447807
SponsorUniversity of Sao Paulo
Last Modified on28 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis according to Diagnostic Manual of Mental Disorders (DSM-5) criteria of Bipolar Disorder type I and II
Adults, age between 18 to 55 years old
Male and/or Female
Education: Must have completed 8 years of Education
Estimated Intelligence Quotient (IQ) ≥80
State of Mood: Euthymia, as to be determined with the use of Young Mania Rating Scale (YMRS) with a score of less than 8 and Montgomery-Åsberg Depression Rating Scale (MADRS) with a score of less than 12
Agreement in participation of the study, via signature obtained by the Informed Consent Form

Exclusion Criteria

Patients with visual sensorial or/and hearing disability that might prevent the correct application of the evaluation
Patients with diagnosis of a organic mental disorder
Abusive use of alcohol or drugs in the last six months
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