Cognitive-Behavioral Rehabilitation Versus Treatment as Usual for Bipolar Patients
试验速览
- 阶段
- 1 期
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Interval to first mood episode
研究概览
简要总结
The study consists of a clinical trial comparing a new structured group intervention, denominated "Cognitive-Behavioral Rehabilitation", to treatment as usual (TAU) for bipolar patients. The new approach is a combination of cognitive behavioral strategies and cognitive rehabilitation exercises, consisting of twelve weekly group sessions of 90 minutes each. To be included in the study, patients must be diagnosed with bipolar disorder, type I or II, be 18 to 55 years old, in full or partial remission and have an IQ of at least 80. A comprehensive neuropsychological battery, followed by mood, social functioning and quality of life assessments will occur in three moments: pre and post-intervention and after 12 months.
详细描述
Methods/Design The study compares Cognitive Behavioral Rehabilitation with Treatment as Usual (TAU), the latter being the commonly offered pharmacological treatment to bipolar patients. The psychological intervention will consist of twelve weekly group sessions, lasting 90 minutes each, and including 8 to 10 individuals. Subjects will be randomly assigned to one of the two arms, and submitted to a 12-month follow-up. During the entire study, all patients will be medicated accordingly to their clinical needs, and all changes in medication will be recorded as a secondary outcome , following the Necessary Clinical Adjustment (NCA) instrument. The NCA records medication adjustments implemented to reduce symptoms, improve response and functioning, or handle unbearable side effects.
Participants In order to be included, patients must be between 18 to 55 years old, literate, present an IQ score higher than 80 and have been diagnosed with bipolar I or II accordingly to DSM-V criteria (APA, 2014). Excluding conditions are: presence of substance or alcohol abuse in the last 6 months, current suicide risk, organic mental disorders or scores higher than 12, in the Montgomery-Asberg Depression Rating Scale (MADRS) or the Young Mania Rating Scale (YMRS) at the beginning of the interventions.
Recruiting will take place at an outpatient service provided by the Bipolar Disorder Research Program (PROMAN) at the University of São Paulo Medical School, Brazil. Patients will receive invitations individually, and sign an informed consent.
Procedure and Outcomes Once included, patients will complete the Portuguese versions of the following self-report questionnaires: the abbreviated instrument of quality of life (WHOQOL-bref), the Barratt Impulsiveness Scale 11 (BIS 11), the Social Skills Inventory (IHS) and the Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN) . Patients will also complete the Functioning Assessment Short Test (FAST) and a brief questionnaire about bipolar disorder.
A brief neuropsychological battery will be conducted, which includes the Wechsler Abbreviated Scale of Intelligence (WASI) (Wechsler, 1999), and following subtests from the Cambridge Neuropsychological Test Automated Battery (CANTAB): Motor Screening Task (MOT); Rapid Visual Information Processing (RVP); Reaction Time (RTI); Spatial Span (SSP); Spatial Working Memory (SWM); One Touch Stockings of Cambridge (OTS); Pattern Recognition Memory (PRM); Delayed Matching to Sample (DMS); Attention Switching Task (AST); Emotion Recognition Task (ERT).
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IQ higher than 80
- •Bipolar I or II diagnoses
- •Being literate
排除标准
- •substance or alcohol abuse in the last 6 months,
- •current suicide risk,
- •organic mental disorders
- •scores higher than 12, in the Montgomery-Åsberg Depression Rating Scale (MADRS) or the Young Mania Rating Scale (YMRS) at the beginning of the interventions.
结局指标
主要结局
Interval to first mood episode
时间窗: 6 months after the beginning of intervention group
Survival data
次要结局
- Change in Brian Sleep Scale(3, 6 and 12 months after the beginning of intervention group)
- Change in Functionality Scale for Bipolar disorder (FAST)(3, 6 and 12 months after the beginning of intervention group)
- Change in Barratt Impulsivity scale (BIS)(3, 6 and 12 months after the beginning of intervention group)
- Change in Social skills scale (IHS)(3, 6 and 12 months after the beginning of intervention group)
- Change in Motor Screening Task(3, 6 and 12 months after the beginning of intervention group)
- Change in Quality of life scores score WHOQOL(3, 6 and 12 months after the beginning of intervention group)
- Change in Rapid Visual Information Processing(3, 6 and 12 months after the beginning of intervention group)
- Change in Reaction time Time Reaction time(3, 6 and 12 months after the beginning of intervention group)
- Change in Spatial Span(3, 6 and 12 months after the beginning of intervention group)
- Change in Delayed Change in Delayed Matching to Sample(3, 6 and 12 months after the beginning of intervention group)
- Change in Attention Switching Task(3, 6 and 12 months after the beginning of intervention group)
- Change in Spatial Working Memory(3, 6 and 12 months after the beginning of intervention group)
- Change in One Touch Stockings of Cambridge Change in Stockings of Cambridge(3, 6 and 12 months after the beginning of intervention group)
- Change in Pattern Recognition Memory(3, 6 and 12 months after the beginning of intervention group)
- Emotion Recognition Change in Emotion Recognition Task(3, 6 and 12 months after the beginning of intervention group)
研究者
Bernardo Carramão Gomes
PhD Student
University of Sao Paulo