Evaluation of the Effectiveness of a Day Patient-caregiver Psychoeducationnal Program on the Burden of Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- caregivers burden
研究概览
简要总结
Bipolar disorder (BD) has a huge impact on the lives of patient and their relatives. Psychoeducation programs on BD has been shown to be effective on the burden of patients and their caregivers. However, actual programs appear to be incompatible with patients obligations and services requirements of the service. The development of "minute" programs (in one day) is justified.
详细描述
Bipolar disorder (BD) has a huge impact on patient lives and their relatives. BD psychoeducation has been shown to be effective on patient disease course and caregivers burden. However, the programs offered appear to be incompatible with the participants obligations and services requirements. In this context we wanted to develop a "minute" program (Bp one day).
Study participation includes 3 visits : inclusion visit and 2 follow up visits.
The main objective is to assess the effectiveness of day psychoeducational program (BP OneDay) on caregiver burden at one month according to the Zarit Caregiver Burden Interview (ZCBI) total score.
This study also aims to assess the effectiveness of BP OneDay on caregiver stigma, patient self-stigma and medication adherence, quality of life, and bipolar disorder knowledge.
The study is an open-label randomized controlled trial with two arms
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •Patient inclusion Criteria:
- •Be over 18 years old;
- •Meet the criteria for bipolar disorder (I, II, unspecified) according to the DSM-5 criteria;
- •Be able to understand the nature, purpose and methodology of the study;
- •Presence of a caregiver
排除标准
- •Subject unable to adhere to the group requirements (cognitive disorder, decompensated mood state ...);
- •Subject protected by law (subject under guardianship and / or guardianship) or deprived of liberty by a judicial or administrative decision;
- •Subject unable to understand, speak and write French;
- •Subject in a period of exclusion from another protocol.
- •Subject not having signed an informed consent
- •Subject not affiliated with a social security scheme or such a scheme
- •Caregiver inclusion criteria ;
- •Subject over 18 years old;
- •Subject designated as a regular caregiver of a patient with bipolar disorder. A regular caregiver is a trusted person designated by the patient as being one of his main support, having knowledge of the diagnosis of bipolar disorder and who can be called upon in the context of care.
- •Subject able to understand the nature, purpose and methodology of the study;
- •Caregiver exclusion criteria :
- •Subject unable to adhere to the groupre quirements (cognitive disorder, decompensated mood state ...);
- •Subject protected by law (subject under guardianship and / or curatorship) or deprived of liberty by a judicial or administrative decision ;
- •Subject unable to understand, speak and write French;
- •Subject in a period of exclusion from another protocol.
- •Subject not having signed an informed consent
- •Subject not affiliated with a social security scheme or such a scheme
研究组 & 干预措施
Bp OneDay programm
The BP One-Day program is based on a single day of psychoeducation .
干预措施: Bp OneDay psychoeducation program (Behavioral)
Waiting List
Patients assigned in control group will be placed in waiting list and will benefit from the program after their participation to this study. During study participation, they will receive treatment as usual.
结局指标
主要结局
caregivers burden
时间窗: Day65 for experimental group, Day35 for control group
evaluation of caregiver burden based on the Zarit Caregiver Burden Interview total score. The Zarit Caregiver Burden Interview is a self-administered questionnaire assessing caregiver burden using 22 items. Five themes are examined: psychological and physical suffering, financial, relational and social difficulties. For each of the 22 items, the caregiver determines how often he feels a given emotion in the helping relationship. This frequency ranges from 0 "never" to 4 "Almost always". The overall score is obtained by adding all the items together, it varies from 0 to 88. The higher the score, the greater the burden felt by the caregiver.
次要结局
- caregivers quality of life(Day65 for experimental group, Day35 for control group)
- Medication Adherence(Day65 for experimental group, Day35 for control group)
- Patient quality of life(Day65 for experimental group, Day35 for control group)
- Bipolar disorder Knowledge in caregivers(Day65 for experimental group, Day35 for control group)
- caregiver satisfaction(Day44 for experimental group, Day14 for control group)
- caregivers stigmatization(Day65 for experimental group, Day35 for control group)
- Internalized Stigma of patients(Day65 for experimental group, Day35 for control group)
- Bipolar disorder Knowledge in patients(Day65 for experimental group, Day35 for control group)
- Patient satisfaction(Day44 for experimental group, Day14 for control group)
- caregivers stigmatization(Day44 for experimental group, Day14 for control group)
- Internalized Stigma of patients(Day44 for experimental group, Day14 for control group)
- Patient quality of life(Day44 for experimental group, Day14 for control group)
- caregivers quality of life(Day44 for experimental group, Day14 for control group)
- Medication Adherence(Day44 for experimental group, Day14 for control group)
- Bipolar disorder Knowledge in patients(Day44 for experimental group, Day14 for control group)
- Bipolar disorder Knowledge in caregivers(Day44 for experimental group, Day14 for control group)