Psychoeducation Versus Cognitive-Behavioral Therapy in Bipolar Disorder
试验速览
- 阶段
- 不适用
- 入组人数
- 210
- 试验地点
- 12
- 主要终点
- Longitudinal Interval Follow-up Evaluation (LIFE; Keller et al, 1987).
研究概览
简要总结
To examine the impact of cognitive-behavioural therapy on both the episodic and functional outcome of bipolar disorder, in combination with pharmacotherapy.
Primary Hypothesis is twofold:
- Cognitive Behavioural Therapy will reduce the total symptom burden, as measured both by percentage of time spent ill (both syndromic and subsyndromal) and number of episodes, as compared to psychoeducation
- Cognitive behavioural therapy will reduce social and occupational disability to a greater extent than psychoeducation.
详细描述
Objective
To compare the impact of cognitive -behavioral therapy to that of properly structured psycho education on the 'illness burden' and functional outcome of bipolar disorder, in combination with pharmacotherapy.
Interventions:
Subjects will be randomized to either a "control" treatment group cosisting of 6 sessions of group psycho-education (topics include illness recognition, treatment approaches, and monitoring and coping strategies; based on manual by Bauer & McBride, 2002: Life Goals Phase I) or they will be randomized to the "experimental" treatment group: 20 sessions of individual Cognitive Behavioural Therapy for Bipolar Disorder (topics include limited psychoeducation, activity scheduling/behavioural interventions, cognitive techniques, including thought monitoring and challenges to dysfunctional assumptions and other coping techniques; based on manual by Lam et al., 1999: Cognitive Therapy for Bipolar Disorder)
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
- None
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
- •Bipolar I or II
- •Currently either in remission or subsyndromally ill (Hamilton Depression Scale-17<14; Clinician Administered Rating Scale for Mania<12).
- •Age eighteen to sixty.
- •Significant symptoms and/or episodes on at least two occasions in the past three years.
- •Grade six education, able to understand English, and Folstein Minimental Score Exam > 26 to ensure cognitive ability to participate.
- •On mood-stabilizing medication.
排除标准
- •Substance dependence meeting Diagnostic and Statistical Manual of Mental Disorders-IV criteria within the last three months.
- •Acutely highly suicidal or homicidal.
- •Serious other medical condition that would render pharmacotherapy or psychotherapy very difficult such as cancer, severe diabetes, etc.
- •Severe antisocial or borderline personality disorder (personality disorder per se is not exclusionary). Subjects may have other axis I disorders, but bipolar disorder must be the principal disorder requiring treatment.
结局指标
主要结局
Longitudinal Interval Follow-up Evaluation (LIFE; Keller et al, 1987).
Modified Social Adjustment Scale (SAS II-B; Bauer, 2001)
***Note: all primary outcomes obtained prospectively every 3 months for 18 months
次要结局
- Clinician Administered Rating Scale for Mania
- Hamilton Depression Rating Scale
- Quality of Life, Enjoyment, and Satisfaction Questionnaire
- Dysfunctional Attitudes Scale
- Patient Satisfaction Index
- Activity and Utilisation Questionnaire
- Medication Compliance scale
- Intensity of Somatotherapy Index
- Coping Inventory for Prodromes of Mania
- Khavari Alcohol Test.
- *****Note: all secondary outcomes measured prospectively over 18 months