A Randomized Controlled Trial Comparing Joint Crisis Plans With Crisis Cards for People With Bipolar Disorders, Schizophrenia and Other Psychotic Disorders to Reduce Involuntary Admission and Coercive Measures.
试验速览
- 阶段
- 不适用
- 入组人数
- 374
- 试验地点
- 2
- 主要终点
- cumulative time in days of involuntary psychiatric hospitalization
研究概览
简要总结
This randomized clinical trial compares the influence of joint crisis plans (JCP) or crisis cards to reduce psychiatric coercion for people with severe and often recurring mental illnesses like schizophrenia, bipolar disorder or schizoaffective disorder. Both interventions will be carried out as an integrated part of otherwise standard psychiatric in-patient and out-patient care in psychiatric units specializing in the acute or non-acute treatment of mentioned mental illnesses.
详细描述
Single open-label randomised clinical trial with parallel control groups.
The intervention group "joint crisis plan" benefits from a joint crisis plan in addition to the usual in-patient care. The active control group "crisis card" benefits from the crisis card in addition to the usual in-patient or out-patient care.
OBJECTIVES:
The study aims at evaluating the effectiveness of a joint crisis plan compared with crisis cards regarding the reduction of coercive measure in the following hospital admission.
PROCEDURES:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mental capacity to consent the participation in the study
- •principal diagnosis according to criteria in ICD-10 main groups F20-F29 or F30-F39
- •patient is residing in the care area of the clinic OR currently at least 2nd inpatient hospital stay in this clinic OR currently treated in a psychiatric outpatients department of the participating clinic
- •at least one psychiatric hospital stay within the last 24 months in any clinic including the current stay OR patient has a history of coercion (involuntary hospitalization, mechanical restraint, isolation, forced medication) in any clinic including the current stay
排除标准
- •clinical impression of insufficient cognitive capacity
- •insufficient understanding of the German language
- •planned transfer to involuntary long-term inpatient care or forensic facilities
- •serious somatic or organic brain disorder (dementia e.g.) or more than slight mental retardation
研究组 & 干预措施
joint crisis plan
Subjects benefit from a joint crisis plan and the process of its negotiation in addition to the usual in-patient or out-patient care.
干预措施: joint crisis plan (Behavioral)
crisis card
Subjects benefit from a crisis card in addition to the usual in-patient or out-patient care.
干预措施: crisis card (Behavioral)
结局指标
主要结局
cumulative time in days of involuntary psychiatric hospitalization
时间窗: 12 month
involuntarily spent psychiatric hospital days during follow-up period
次要结局
- cumulative frequency of forced medication(12 month)
- cumulative duration of mechanical restraint(12 month)
- cumulative duration of isolation(12 month)