Bipolar Disorder Clinical Trial
Official title:
Rehabilitating Theory of Mind: A Randomized Control Study Using Metacognitive Training in a Group Format With Bipolar Disorder Patients.
Verified date | June 2024 |
Source | University of Sao Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 | Active, not recruiting |
Enrollment | 52 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Institute of Psychiatry, Clinic Hospital University of São Paulo | São Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo |
Brazil,
Haffner P, Quinlivan E, Fiebig J, Sondergeld LM, Strasser ES, Adli M, Moritz S, Stamm TJ. Improving functional outcome in bipolar disorder: A pilot study on metacognitive training. Clin Psychol Psychother. 2018 Jan;25(1):50-58. doi: 10.1002/cpp.2124. Epub — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | Baseline and Follow-up (10 weeks) | |
Primary | 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. | Baseline and Follow-up (10 weeks) | |
Secondary | 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. | Baseline and Follow-up (10 weeks) | |
Secondary | 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. | Baseline and Follow-up (10 weeks) | |
Secondary | 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. | Baseline and Follow-up (10 weeks) | |
Secondary | 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. | Baseline and Follow-up (10 weeks) |
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