Community Based Group Psychoeducation for Relatives of Individuals With Mental Illness: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 744
- 试验地点
- 1
- 主要终点
- Retention rate
研究概览
简要总结
The goal of this one-arm pre-test/post-test study is to evaluate the feasibility and preliminary effect of a community-based psychoeducational group intervention for informal caregivers of individuals with mental illness.
The main questions it aims to answer are:
- What is the feasibility and acceptability of the intervention?
- What is the preliminary effect of the intervention?
Participants self-select to the intervention and participation in the evaluation is voluntary. Participants will be asked to:
- Answer a questionnaire before and after their participation
- Some participants will be invited for an in-depth interview
There is no comparison group, but feasibility and acceptability will also be explored by asking the implementation team (e.g. project leaders and teachers) to participate in:
- In-depth interviews
- Answering shorter questionnaires about provider acceptability
详细描述
The program/intervention:
The group-based psychoeducational program focuses on enhancing informal caregivers' or relatives' understanding of their loved ones' mental illnesses and equips them with coping strategies. The main goal is to improve caregivers' knowledge of mental illnesses and their ability to navigate in their daily life/their role as an informal caregiver without becoming overburdened.
The specific program was collaboratively developed by a non-government organization and the regional psychiatry in one of Denmarks five Regions. Participants self-select to the program and participation is free of cost.
The program consists of six sessions, two of which are conducted online. The program is designed for groups of 16-20 individuals.
Session 1: The first session serves as an introduction to the program, where participants get acquainted with each other and familiarize themselves with the program's content. During this session, participants are encouraged to establish their own rules while also discussing the "Chatham House rules."
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- •Age 18 years or older
- •Able to read, speak, and understand the Danish langugage
- •Relative/informal caregiver of an individual with a mental illness
排除标准
- 未提供
研究组 & 干预措施
Psychoeducation
The experimental condition consists of a psychoeducation program with six sessions. Two of the sessions are online. A teacher and a volunteer will lead the sessions. The topic of the sessions are diverse and cover topics such as mental illness, the diathesis-stress model, treatment of mental illness, caregiver coping mechanisms and caregiver rights.
Before the first session, participants are asked to fill in an online questionnaire with background information and well-being indicators. After the last session, participants are asked to fill in another short questionnaire with the same well-being indicators and also a measure of their satisfaction with the program.
干预措施: The intervention is community based group psychoeducation (Behavioral)
结局指标
主要结局
Retention rate
时间窗: Retention rates are monitored throughout the study period (1 year)
To measure feasibility of the intervention, there is a measure of retention rate: (number of participants remaining/intital Number of Enrolled Participants) \* 100
Recruitment rate
时间窗: Recruitment rate is monitored throughout the study period (1 year)
To measure the feasibility of the intervention, there is a measure of recruitment rate (number of participants recruited/time period in months).
Barriers and facilitators, qualitative measure (provider perspective)
时间窗: Focus-group interviews will be conducted throughout the study period (1 year).
Based on focus-group interviews with the teachers and other stakeholders, qualitative data will be collected to understand the providers' experiences, perceptions, and suggestions for improvement of the program.
Satisfaction, quantitative measure
时间窗: Immediatly after participants finish the last session (session six, either 35 days or 70 days after enrolling in the intervention).
To measure acceptability of the intervention, participants' overall satisfaction with the program will be measured. This measure is based on 11 questions, that are rated on a 4-point Likert-Scale. Higher scores indicate higher satisfaction.
Satisfaction, qualitative measure
时间窗: Immediatly after participants finish the last session (session six, either 35 days or 70 days after enrolling in the intervention).
To measure acceptability of the intervention, participants are invited to write about their experience with the program and their ideas for program development.
Suitability, qualitative measure
时间窗: Individual semi-structured interviews will be conducted throughout the study period (1 year).
Based on individual semi-structured interviews with some of the participants the investigators will evaluate whether the intervention fits the target population's needs, preferences, and cultural context. This measure will be used to assess whether any modifactions are needed to enhance the programme suitability.
Attendance rate
时间窗: Attendance rates are monitored throughout the study period (1 year)
To measure feasibility of the intervention, there is a measure of attendance rate: (number of participants attending/total number of enrolled participants) \* 100
次要结局
- Personal Burnout: Copenhagen Burnout Inventory (CBI; personal burnout)(1 week before the first session, and immediatly after the last session (session six, either 35 days or 70 days after enrolling in the intervention).)
- Well-being: WHO-5 well-being index(1 week before the first session, and immediatly after the last session (session six, either 35 days or 70 days after enrolling in the intervention).)
- Coping: Brief resilient coping scale(1 week before the first session, and immediatly after the last session (session six, either 35 days or 70 days after enrolling in the intervention).)