NCT04447807Active, not recruiting
Metacognitive Training With Bipolar Disorder Patients.
Rehabilitating Social Cognition: A Randomized Control Study Using Metacognitive Training in a Group Format With Bipolar Disorder Patients.
Source: ClinicalTrials.gov · Last updated 30 Mar 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 52 (estimated)
- First submitted
- 8 Jun 2020
- Start date
- 20 Feb 2022
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- University of Sao Paulo
- Diseases
- Bipolar disorder
- NCT number
- NCT04447807
What you commit to
- Study type: Interventional
- Planned participants: 52
- From 20 Feb 2022 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with electroconvulsive therapy in the last 12 months.
Other illness
- 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.
Who the study is looking for
- 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).
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute of Psychiatry, Clinic Hospital University of São Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.