SOSteniamoci: An Internet-based Intervention to Support Informal Caregivers.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Cargiver Burden Inventory (CBI)
研究概览
简要总结
The purpose of this study is to evaluate efficacy of internet intervention for informal caregivers in Italy in reducing their care-giving burden.
详细描述
This intervention is going to take a form of an Internet-based Intervention (IBI) consisting of eight therapeutic modules. These are the themes, as listed chronologically: Introduction, Thoughts and Acceptance, Problem Solving, Stress and relaxation, Communication, Behavioural Activation, Worry and Anxiety, Maintenance. These themes were chosen after considering topics which might be the most useful for someone in a role of an informal caregiver, considering the trans-diagnostic nature of the intervention.
Effect of the intervention will be compared against a wait-list control group. Intervention is in Italian.
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
- 是
入选标准
- •18 years old or over and both gender;
- •spent at least the last couple of months providing care;
- •must have internet access and the ability to use a computer or any other compatible device;
- •must be able to complete a phone interview -
排除标准
- •having severe physical or mental impairments, psychiatric conditions or neurological disorders; 2) the person in need of care has a life expectancy below or approximately around 6 months; 3) not able to use a computer or an electronic device; 4) not able to complete a phone interview;
结局指标
主要结局
Cargiver Burden Inventory (CBI)
时间窗: Pre-treatment; Week 8; 12 months post-treatment
This measure is used to evaluate caregiver burden. CBI contains 24 questions that are distributed within 5 facets - Time Dependency, Emotional Health, Development, Physical Health and Social Relationships. Answer options are presented on a 5-item Likert scale and ranges from from 0 ('Never') to 4 ('Nearly Always'). Total score on CBI is summed up and ranges from 0 to 96, higher score indicating higher levels of burden experienced.
次要结局
- Perceived Stress Scale (PSS-10)(Pre-treatment; Week 8; 12 months post-treatment)
- The Patient Health Questionnaire (PHQ-9)(Pre-treatment; Week 8; 12 months post-treatment)
- World Health Organization (WHO-5)(Pre-treatment; Week 8; 12 months post-treatment)
- Couple Satisfaction Inventory (CSI-4)(Pre-treatment; Week 8; 12 months post-treatment)
- Generalized Anxiety Disorder (GAD-7)(Pre-treatment; Week 8; 12 months post-treatment)
- The Inclusion of Illness in the Self Scale (IIS) - Caregiver version(Pre-treatment; Week 8; 12 months post-treatment)
研究者
Noa Vilchinsky
Principal Investigator
Bar-Ilan University, Israel