Clinical trial NCT04447807: Metacognitive Training With Bipolar Disorder Patients.
Official title: Rehabilitating Social Cognition: A Randomized Control Study Using Metacognitive Training in a Group Format With Bipolar Disorder Patients.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Bipolar Disorder
Keywords: Bipolar Disorder
Theory of Mind
Social Cognition
Metacognitive Training
Cognitive Rehabilitation
Cognitive Impairment
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2020-06-25
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients eligible for this study will be randomized into two groups: Metacognitive Training Intervention (9 weeks) or Treatment as Usual (9 weeks).
Primary purpose: TREATMENT

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).

Detailed description: 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 Emotion Recognition, 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 Objectives To assess the overall effectiveness of MCT-BD (Metacognitive Training for Bipolar Disorder) in enhancing social cognition (theory of mind and emotion recognition) among euthymic individuals with Bipolar Disorder (BD).

Specific Objectives

Primary Efficacy Objectives:

1. To test the effectiveness of MCT-BD in improving Theory of Mind (ToM) among euthymic individuals with BD.
2. To test the effectiveness of MCT-BD in improving Emotion Recognition (ER) among euthymic individuals with BD.

Exploratory Objectives:

1. To assess the improvements in overall psychosocial functioning and quality of life of participants receiving MCT-BD compared to those receiving treatment as usual (TAU).
2. To assess the impact neurocognitive variables of participants receiving MCT-BD compared to those receiving treatment as usual (TAU)
3. To examine the effects of the intervention on mood variables within the same group.

General Objectives To assess the overall effectiveness of MCT-BD (Metacognitive Training for Bipolar Disorder) in enhancing social cognition among euthymic individuals with Bipolar Disorder (BD).

To deepen our understanding of social cognition in BD and lay the groundwork for tailored interventions aimed at improving psychosocial outcomes in this population.

Specific Objectives

Primary Efficacy Objectives:

To test the effectiveness of MCT-BD in improving Theory of Mind (ToM) among euthymic individuals with BD.

To evaluate the impact of MCT-BD on Emotion Recognition (ER) in the same population.

To assess the improvements in overall psychosocial functioning of participants receiving MCT-BD compared to those receiving treatment as usual (TAU).

Exploratory Objectives:

To investigate the impact of MCT-BD on neurocognitive variables in euthymic individuals with BD.

To examine the effects of the intervention on mood variables within the same group.

Hypothesis

We hypothesized that participants receiving MCT-BD would demonstrate significant improvements in:

Theory of Mind (ToM) Emotion Recognition (ER) Overall Psychosocial Functioning

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 ER. 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 TAU 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 (TAU) 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 (TAU). 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.

Eligibility criteria: 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 outcomes:
measure: Theory of Mind
timeFrame: Baseline and Follow-up (10 weeks)
measure: Emotion Recognition
timeFrame: Baseline and Follow-up (10 weeks)
Secondary outcomes:
measure: Functioning Outcome
timeFrame: Baseline and Follow-up (10 weeks)
measure: Neuropsychological outcome
timeFrame: Baseline and Follow-up (10 weeks)
measure: Quality of Life outcome
timeFrame: Baseline and Follow-up (10 weeks)
measure: Mood outcome measures
timeFrame: Baseline and Follow-up (10 weeks)
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Institute of Psychiatry, Clinic Hospital University of São Paulo
Study officials:
affiliation: Associate Professor of the Department of Psychiatry, USP
name: Beny Lafer
role: STUDY_DIRECTOR
References: