Metacognitive Training With Bipolar Disorder Patients.
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed 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:
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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.
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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.
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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:
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Montomery&Asberg Scale for Depression(MADRS)
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Young Scale for Mania
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Scale of Quality of Life (WHOQoL- bref)
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Scale for Functionality(FAST)
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Neuropsychological Evaluation: Cambridge Automated Neuropsychological Test Automated Battery (CANTAB): Evaluates cold and hot cognitive domains).
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group A: Metacognitive Training Intervention Participants of this group will under go Metacognitive Training (MCT) in group format for the duration of 8 weeks. The intervention will be helf once a week, with an estimate duration of 1-2 hours. The MCT intervention focuses on rehabilitating Social Cognition and teaching skills of inter-personal relations, as well as functional remediation aspects. We estimate a total of 45 participants in this group. |
Behavioral: 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 8 weeks total.
Other Names:
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| Experimental: Group B: Treatment as Usual 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 45 participants in this group. |
Other: 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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Change From Baseline in Theory of Mind Scores (RMET) at 9 Weeks in MCT group when compared to TAU group. [Changes from baseline Theory of Mind scores (RMET) at 9 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).
- Change From Baseline in Theory of Mind Scores ( Faux Pas Recognition Test) at 9 Weeks in MCT group when compared to TAU group. [Changes from baseline Theory of Mind scores (Faux Pas) at 9 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 Faux Pas Recognition Task. The Faux Pas Recognition Task consists of 10 Faux Pas Stories and 10 Control Stories without a faux pas, scoring one point for every correct faux pas perception. The higher score is 20 and lower score 0, domain scores are scaled in a positive direction (i.e. higher scores denote higher theory of mind).
- Change From Baseline in Theory of Mind Scores (RMET) at 12 Months in MCT group when [Changes from baseline Theory of Mind scores (RMET) at 12 Months]
After the intervention, the group that received the MCT intervention will present changes from baseline Theory of Mind (ToM) scores at 12 Months, 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).
- Change From Baseline in Theory of Mind Scores ( Faux Pas Recognition Test) at 12 Months in MCT group when compared to TAU group. [Changes from baseline Theory of Mind scores (Faux Pas) at 12 Months.]
After the intervention, the group that received the MCT intervention will present changes from baseline Theory of Mind (ToM) scores at 12 Months, when compared to TAU group. ToM Scores is evaluated by using Faux Pas Recognition Task. The Faux Pas Recognition Task consists of 10 Faux Pas Stories and 10 Control Stories without a faux pas, scoring one point for every correct faux pas perception. The higher score is 20 and lower score 0, domain scores are scaled in a positive direction (i.e. higher scores denote higher theory of mind).
Secondary Outcome Measures
- Change From Baseline in Social Cognition Scores (CANTAB Taks of Social and Emotional Cognition) at 9 Weeks in MCT group when compared to TAU group. [Changes from baseline Social Cognition scores at 9 weeks.]
After the intervention, the group that received the MCT intervention will present changes from baseline Social Cognition scores at 9 weeks, when compared to TAU group. Social Cognition Scores will be obtained by using the Social and Emotional Cognition Tasks in the Cambridge Neuropsychological Test Automated Battery (CANTAB). The Social&Emotional Cognition Tasks are the Emotion recognition task (ERT) and the Emotional Bias Task(EBT). The outcome measures for ERT cover percentages and numbers correct or incorrect and overall response latencies, which can be looked at either across individual emotions or across all emotions at once.The key outcome measure for the EBT is the bias point - the proportion of trials selected as happy compared to the alternative emotion, adjusted to a scale of 0 to 15. Additionally, latency measures and measures of how many times each emotion was selected are also available.
- Change From Baseline The World Health Organization Quality of Life - BREF scores (WHOQoL- bref) at 12 months in MCT group when compared to TAU group. [Changes from baseline The World Health Organization Quality of Life - BREF scores at 12 months.]
After 12 months, the group that received the MCT intervention will present changes from baseline The World Health Organization Quality of Life - BREF scores at 12 months weeks, when compared to TAU group. The scale used to evaluate quality of life is Scale of Quality of Life (WHOQoL- bref), instrument comprises 26 items, the minimum value being 0 and maximum value being 26, domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life).
- Changes from Baseline in Functional Assessment Short Test (FAST) scores (FAST) at 12 months in MCT group when compared to TAU group. [Changes from baseline Functional Assessment Short Test (FAST) scores at 12 months.]
After 12 months, the group that received the MCT intervention will present changes from baseline Functionality scores at 12 months weeks, when compared to TAU group. The scale used to evaluate functionality is the Functional Assessment Short Test (FAST) Scale (FAST) the minimum value being 0 and maximum value of 72, domain scores are scaled in a negative direction (i.e. lower scores denote higher functionality).
- Changes from Baseline in Reaction Time scores a subtest of the Cambridge Neuropsychological Automated Battery Test (CANTAB) at 12 months in MCT group when compared to TAU group [Changes from baseline Reaction Time (CANTAB subtest) scores at 12 months.]
After 12 months, the group that received the MCT intervention will present changes from baseline Reaction Time scores at 12 months weeks, when compared to TAU group. The scale is a subtest part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). Reaction Time scores the minimum is 100 and maximum values is 5100. Domain scores are scaled in a positive direction (i.e higher scores denote higher cognitive abilities).
- Changes from Baseline in Verbal Recognition Memory scores a subtest of the Cambridge Neuropsychological Automated Battery Test (CANTAB) at 12 months in MCT group when compared to TAU group. [Changes from baseline Verbal Recognition Memory (CANTAB subtest) scores at 12 months.]
After 12 months, the group that received the MCT intervention will present changes from baseline in Verbal Recognition Memory scores at 12 months weeks, when compared to TAU group. The scale is a subtest part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). Reaction Time scores the minimum is 24 and maximum values is 36. Domain scores are scaled in a positive direction (i.e higher scores denote higher cognitive abilities).
- Changes from Baseline in Spatial Working Memory scores a subtest of the Cambridge Neuropsychological Automated Battery Test (CANTAB) at 12 months in MCT group when compared to TAU group. [Changes from baseline Spatial Working Memory (CANTAB subtest) scores at 12 months.]
After 12 months, the group that received the MCT intervention will present changes from baseline in Spatial Working Memory Span scores at 12 months weeks, when compared to TAU group. The scale is a subtest part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). Reaction Time scores the minimum is 0 and maximum values is ∞. Domain scores are scaled in a negative direction (i.e higher scores denote lower cognitive abilities).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis according to Diagnostic Manual of Mental Disorders (DSM-5) criteria of Bipolar Disorder type I and II.
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Adults, age between 18 to 55 years old.
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Male and/or Female
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Education: Must have completed 8 years of Education.
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Estimated Intelligence Quotient (IQ) ≥80.
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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.
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Agreement in participation of the study, via signature obtained by the Informed Consent Form
Exclusion Criteria:
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Patients with visual sensorial or/and hearing disability that might prevent the correct application of the evaluation.
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Patients with diagnosis of a organic mental disorder
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Abusive use of alcohol or drugs in the last six months
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institute of Psychiatry, Clinic Hospital University of São Paulo | São Paulo | Brazil | 05403-903 |
Sponsors and Collaborators
- University of Sao Paulo
Investigators
- Study Director: Beny Lafer, Associate Professor of the Department of Psychiatry, USP
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 4040551
- 3148742040000068