Rehabilitating Social Cognition: A Randomized Control Study Using Metacognitive Training in a Group Format With Bipolar Disorder Patients.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Theory of Mind
研究概览
简要总结
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).
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Theory of Mind
时间窗: 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
时间窗: 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.
次要结局
- Neuropsychological outcome(Baseline and Follow-up (10 weeks))
- Quality of Life outcome(Baseline and Follow-up (10 weeks))
- Functioning Outcome(Baseline and Follow-up (10 weeks))
- Mood outcome measures(Baseline and Follow-up (10 weeks))
研究者
Beny Lafer
Associate Professor of the Department of Psychiatry (IPq), University of São Paulo Medical School
University of Sao Paulo