Feasibility RCT of the Efficacy of a Culturally Adapted Psychological Intervention for Bipolar Disorder in Pakistan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Young Mania Rating Scale(YMRS)
研究概览
简要总结
Aim:
To assess the Feasibility RCT of the efficacy of a culturally adapted psychological intervention for Bipolar disorder in Pakistan
Design:
Randomized Control Trial
Setting:
Psychiatric Departments of different Hospitals in Karachi.
Participants:
A total of 36 Bipolar disorder patients will be randomized to psychological Intervention and treatment as usual arm.
Intervention:
Culturally Adapted psychological intervention for bipolar disorder
Outcome measure:
- Acceptance of intervention in terms of attending session and dropouts
- Knowledge and attitudes towards bipolar disorder
详细描述
The purpose of the study is to test Feasibility RCT of the efficacy of a culturally adapted psychological intervention for Bipolar disorder in Pakistan
Primary Objectives :
- To determine effectiveness of educational intervention in terms of patient Satisfaction with overall care, knowledge and attitudes to bipolar disorder and medication adherence.
- To assess feasibility in terms of
- Recruitment
- Using instruments that will be used to assess recurrence rate in the main study (BDI, YMRS and obtaining prospective hospitalisation and medication data)
- acceptability of a culturally adapted bipolar group education package
- To allow 'fine tuning' of culturally adapted bipolar group education package (this will partly be achieved by using the SEMI at study entry)
The Participants will be recruited from psychiatric department of different hospitals.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of DSM IV Bipolar disorder
- •Currently stable (YMRS <8, BDI<12)
- •Age 18 to 65 years.
- •Participants engaged with the mental health services since last 6 months.
- •Able to give written informed consent.
- •Resident of trial catchments area
- •Ability to speak Urdu /Punjabi
排除标准
- •Substance or alcohol dependent (i.e., those who fulfill the criteria for dependence according to DSM IV criteria)
- •Inability to engage fully in the psychotherapy (due to cognitive impairment)
- •Actively suicidal
- •Any major psychiatric illness other than bipolar disorder
结局指标
主要结局
Young Mania Rating Scale(YMRS)
时间窗: three months
The Young Mania Rating Scale (YMRS) is one of the most frequently utilized rating scales to assess manic symptoms
Knowledge and attitudes
时间窗: three months
Knowledge and attitudes towards bipolar disorder measured by using a standard questionnaire
Beck's Depression Inventory Scale (BDI)
时间窗: three months
The BDI is a measure of depression severity and has been used in several previous studies in Pakistan and is validated for use in Urdu.
次要结局
- Visual Analogue Scale(three months)
- Medication adherence(three months)
- Short Explanatory Model Interview(three months)