Metacognitive Training With Bipolar Disorder Patients.

Study Overview
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Brief Summary
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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).

Detailed Description
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The present study is justified by the importance of understanding, both theoretically and practically, psychotherapeutic interventions aimed at rehabilitating social cognition (SC) and specifically Theory of Mind (ToM) in individuals diagnosed with bipolar disorder (BD). ToM is an essential component for social interaction and, therefore, impairment in this area leads to problems related to interpersonal functioning. The majority of group rehabilitation interventions proposed for BD have focused primarily on cold cognitive domains or, in some cases, have only reserved one to two meetings to address strategies that integrate SC. BD is a heterogeneous disorder in terms of sociocognitive impairments and, therefore, demands more specific interventions for each individual (personalized medicine). Thus, the proposed intervention corresponds to a specific focus on functional rehabilitation of social cognition, with a focus on ToM, and has not yet been evaluated in this population through a randomized controlled trial. Therefore, MCT intervention may be promising as a psychotherapeutic intervention for patients who present deficits in ToM (evaluated through their functionality). Objectives General objective To evaluate the effectiveness of MCT intervention through a randomized controlled trial in euthymic patients diagnosed with BD, using Theory of Mind measures (using the RMET scale). Specific objectives To analyze the dynamics of changes between ToM and SC with the functionality scale (FAST). In this way, it is better understood if: (i) as ToM improves, FAST also improves (synchronicity)? And (ii) as SC improves, FAST also improves? (iii) Is there a correlation between the change of the two before and after intervention? To evaluate, analyze, and demonstrate, through neuropsychological assessment in a descriptive-analytical study, qualitative and quantitative aspects of Social Cognition processes in patients with BD. Material and Methods All participants will be recruited from patients regularly enrolled and clinically followed up at the Bipolar Disorder Program - PROMAN - outpatient clinic at Hospital das Clínicas, Faculty of Medicine, University of São Paulo. Participants will have access to the Informed Consent Form (ICF) for this research, and only those who agree to participate will be included in the study. This study aims to evaluate the efficacy of the MCT intervention with a specific focus on ToM and CS. To this end, the methodological proposal is divided into two stages: 01) Neuropsychological Evaluation of Cognition, ToM, and Social Cognition, and 02) MCT Intervention versus TAU. Randomization Individuals with Bipolar Disorder recruited for the research will be randomized to the MCT arm or TP arm through the Pass 22 tool using a true random algorithm. Procedures All patients who meet the described criteria and agree to participate in the study by signing the research consent form will be evaluated using the proposed neuropsychological battery. To proceed to the next stage of the project (intervention), only patients who have a deficit (represented by a score of 12 or more points) on the functionality scale (Rosa et al., 2007) will be randomly distributed (using the Pass 22 tool and a true random algorithm by a third party blinded to the research) between the experimental (MCT) and control (TP) groups. Twenty-six patients in the experimental group will participate in 9 weekly sessions following the MCT intervention proposal developed for this study. This will be based on a protocol recently developed for patients with TB by Haffner and colleagues (Haffner et al., 2018) and adapted and translated by the author of this project, Luisa de Siqueira Rotenberg, with authorization and approval for necessary modifications by the original authors. The other twenty-six patients in the control group will receive standard treatment (TP). All patients will also be accompanied by medical consultations at the Bipolar Disorder Program outpatient clinic (PROMAN, IPq-HCFMUSP), which will be scheduled according to medical evaluation. The amount of medication used and the number of medical consultations will not be limited in this study, with the aim of increasing the generalization of possible results to real clinical situations. However, these variables will be subsequently observed through medical records produced during these consultations. The neuropsychological assessment battery will be applied to all participants before the start of therapy groups and will be reapplied after the end of the intervention.

Official Title
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Rehabilitating Theory of Mind: A Randomized Control Study Using Metacognitive Training in a Group Format With Bipolar Disorder Patients.

Conditions
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Bipolar Disorder

Intervention / Treatment
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* Behavioral: Metacognitive Training
* Other: Treatment as Usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria 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). Exclusion Criteria 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients eligible for this study will be randomized into two groups: Metacognitive Training Intervention (9 weeks) or Treatment as Usual (9 weeks).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A: Metacognitive Training Intervention<br>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<br>* 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.<br>* Other names: MCT;|
| Experimental: Group B: Treatment as Usual<br>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<br>* Patients will continue to receive medical attention in the Bipolar Disorder Program -PROMAN- part of the University of São Paulo Medical School.<br>* Other names: TAU;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 9 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functioning Outcome | The functional assessment scale (FAST): FAST is a standardized rating scale that is used to assess the functional impairment of individuals with bipolar disorder. The scale is designed to assess the level of functional impairment across a range of domains including autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships, and leisure time. The FAST is typically administered as an interview-based assessment, with the interviewer asking questions about the individual's ability to perform specific tasks and activities in each of these domains. | 9 weeks | 
| Social Cognition | Social cognition 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. | 9 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bipolar Disorder, Theory of Mind, Social Cognition, Metacognitive Training, Cognitive Rehabilitation, Cognitive Impairment