Pilot Study of Culturaly Adapted Family Intervention for Psychosis
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
- Positive and Negative syndrome scale (PANSS)
研究概览
简要总结
Aim:
To assess the feasibility of culturally adapted Family Intervention for Psychosis.
Design:
Randomized Control Trial
Setting:
psychiatric department of different hospitals
Participants:
A total of 36 caregivers of Psychosis patients will be randomized to psychological Intervention and treatment as usual arm.
Intervention:
Culturally Adapted Family Intervention for Psychosis
Outcome measure:
Positive and Negative syndrome scale (PANSS) Experience of care -giving inventory(ECI) Care Well-Being & Support(CWS)
详细描述
The purpose of the study is to test the feasibility of culturally adaptive family intervention for Psychosis
Primary Objective :
- To test whether Pakistani families caring for someone with psychosis will engage with a model of family intervention which has been culturally adapted to meet their needs.
- To evaluate the acceptability of the intervention to the families who receive it and to gather feedback regarding any changes that might improve the intervention.
- To gain an impression of whether the intervention has the potential to address unmet psychological and social needs of the families and how this affects their levels of stress
the investigators will conduct a feasibility pilot study to test whether Pakistani families offered the intervention will want to receive it. The Participants will be recruited from psychiatric department of different hospitals. They will be randomly divided into two groups; intervention group and treatment-as-usual group. A total of thirty six participants will be recruited in the pilot study and divided equally into two arms. This will ensure that, even after loss to follow-up, we will have at least 12 subjects per group for analysis (FDA guidance http://www.fda.gov/cder/guidance/5356fnl.pdf).Randomization will be carried out by the on offsite statistician. This will provide a reliable geographically remote service. For intervention group ten sessions of family intervention will be provided by trained research clinician during the period of three months. Relatives of Patients in the treatment as usual (TAU) group will be given details of intervention at the end of the study and interested families will be offered family intervention
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Living with or with at least 10 hours per week face to face contact with an individual with psychosis who has a caring role. Plus the individual with psychosis themselves.
- •Individuals aged between 18-
- •Resident of Karachi.
- •Participant is able to give informed written consent.
排除标准
- •Severe drug or alcohol problem (i.e., those who fulfill the criteria for dependence according to ICD10 RDC).
- •Unstable residential arrangements such that the likelihood of being available for the duration of the trial is low.
结局指标
主要结局
Positive and Negative syndrome scale (PANSS)
时间窗: six months
The PANSS is a structured clinical interview consisting of 30 items designed to assess severity of symptoms over the past week on a 7-point scale.
Experience of Care-giving inventory(ECI)
时间窗: six months
Commonly apply to persons who care for relative or friends With a serious mental illness
Carer Wel-Being & Support(CWS)
时间窗: six months
A questionnaire for carers of people with a mental Health problem
次要结局
- Family Questionnaire(FQ)(six months)
- Insight rating scale(six months)
- Short Explanatory Model Interview(six months)
- Calgary Depression Scale for Schizophrenia(six months)