Bipolar DisorderNCT04447807
Metacognitive Training With Bipolar Disorder Patients.
A study testing Metacognitive Training and Treatment as Usual in people with Bipolar Disorder, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Metacognitive Training and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Feb 2022to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Institute of Psychiatry, Clinic Hospital University of São Paulo
São Paulo, 05403-903
About this study
Official title: Rehabilitating Social Cognition: A Randomized Control Study Using Metacognitive Training in a Group Format With Bipolar Disorder Patients.
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).
Read the 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:
- To test the effectiveness of MCT-BD in improving Theory of Mind (ToM) among euthymic individuals with BD.
- To test the effectiveness of MCT-BD in improving Emotion Recognition (ER) among euthymic individuals with BD.
Exploratory Objectives:
- 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).
- To assess the impact neurocognitive variables of participants receiving MCT-BD compared to those receiving treatment as usual (TAU)
- 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.
- Conditions
- Bipolar Disorder
- Being tested
- Metacognitive Training, Treatment as Usual
- Keywords
- Bipolar Disorder, Theory of Mind, Social Cognition, Metacognitive Training, Cognitive Rehabilitation, Cognitive Impairment
- Medical subject headings
- Bipolar Disorder, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metacognitive TrainingBehavioural
Also called MCT
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.
Treatment as UsualOther
Also called TAU
Patients will continue to receive medical attention in the Bipolar Disorder Program -PROMAN- part of the University of São Paulo Medical School.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Baseline and Follow-up (10 weeks)
Secondary outcomes (4)
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.
Measured: Baseline and Follow-up (10 weeks)
Neuropsychological outcome
The CANTAB subtests were chosen to provide objective measures of cognitive performance across domains such as reaction time, working memory, sustained attention, and verbal memory.
Measured: Baseline and Follow-up (10 weeks)
Quality of Life outcome
The brief version of the World Health Organization Quality of Life questionnaire (WHOQOL-BREF) was utilized to evaluate global well-being subjectively.
Measured: Baseline and Follow-up (10 weeks)
Mood outcome measures
The severity of manic and hypomanic symptoms was assessed using the Young Mania Rating Scale (YMRS) which comprises 11 items designed to evaluate the intensity of these symptoms The Montgomery Asberg Rating Scale (MADRS) was used to assess the severity of depression symptoms in patients. It consists of a 10-item questionnaire that evaluates various aspects of depression, quantitatively measuring symptom severity.
Measured: Baseline and Follow-up (10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start20 Feb 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beny Lafer, University of Sao Paulo
- Investigators
- Beny Lafer, Study director, Associate Professor of the Department of Psychiatry, USP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04447807
- Sponsor's protocol ID
- 4040551
- Other IDs
- 3148742040000068
- Status last verified
- Mar 2025
- First submitted
- 8 Jun 2020
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitating Social Cognition: A Randomized Control Study Using Metacognitive Training in a Group Format With Bipolar Disorder Patients.
- ClinicalTrials.gov ID
- NCT04447807
- Acronym / sponsor ID
- 4040551
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar Disorder, Theory of Mind, Social Cognition, Metacognitive Training, Cognitive Rehabilitation, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 20 Feb 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 25 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To test the effectiveness of MCT-BD in improving Theory of Mind (ToM) among euthymic individuals with BD.
- To test the effectiveness of MCT-BD in improving Emotion Recognition (ER) among euthymic individuals with BD.
Exploratory Objectives:
- 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).
- To assess the impact neurocognitive variables of participants receiving MCT-BD compared to those receiving treatment as usual (TAU)
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Patients eligible for this study will be randomized into two groups: Metacognitive Training Intervention (9 weeks) or Treatment as Usual (9 weeks).
| Arm | Type | Receives |
|---|---|---|
| Group A: Metacognitive Training Intervention | Experimental | Behavioral: Metacognitive TrainingParticipants 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. |
| Group B: Treatment as Usual | Experimental | Other: Treatment as UsualParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metacognitive TrainingAlso: MCTMCT 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. | Behavioural | Group A: Metacognitive Training Intervention |
| Treatment as UsualAlso: TAUPatients will continue to receive medical attention in the Bipolar Disorder Program -PROMAN- part of the University of São Paulo Medical School. | Other | Group B: Treatment as Usual |
Primary outcome
Theory of Mind
Time frame: Baseline and Follow-up (10 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).
Emotion Recognition
Time frame: Baseline and Follow-up (10 weeks)
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.
4 secondary outcomes
Functioning Outcome
Time frame: Baseline and Follow-up (10 weeks)
Neuropsychological outcome
Time frame: Baseline and Follow-up (10 weeks)
Quality of Life outcome
Time frame: Baseline and Follow-up (10 weeks)
Mood outcome measures
Time frame: Baseline and Follow-up (10 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beny Lafer study director
Associate Professor of the Department of Psychiatry, USP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metacognitive Training and Treatment as Usual in people with Bipolar Disorder, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Theory of Mind (time frame: Baseline and Follow-up (10 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.