Evaluation of a Self-compassion App in People With Cancer: Feasibility, Acceptability and Changes in Well-being
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Self-compassion
研究概览
简要总结
To support patients with cancer with managing psychological distress due to their illness and treatment, a self-help digital Compassionate Mind Training (i.e., Compas-Y App) was developed in co-creation with people with cancer and nurses in oncology.
This study will examine : What is the feasibility, acceptability, and effectiveness of Compas-Y app in distressed cancer patients? The reseachers use a multiple baseline design, with a 2-3 week baseline phase and a 6-week intervention phase.
Adult patients (>= 18 years) will be approached for the study, who finished their medical treatment and who experience a reduced well-being.
To examine the effects of Compas-Y, the researchers will examine changes in self-compassion and self-criticism (primary outcomes) and mindfulness, emotion regulation strategies, and positive and negative affect (secondary outcomes). We will use EMA items to assess momentary levels of these primary and secondary outcomes.
These assessments will be 3 times per week at 7:00 PM, both during the 2-3 week baseline phase ( 6-9 assessments in total) and the 6-week intervention phase (18 times assessments in total).
The expectation is increases in self-compassion, reductions in self-criticism, and improved affect as well as improved mindfulness and emotion regulation. In addition, the expectation is more improvement in outcomes in those patients with greater usage of the app.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •aged 18 and older;
- •Diagnosed with cancer (stage I-III);
- •Completed medical treatment in the past 2 years;
- •Reporting a reduced well-being (Mental Health Inventory (MHI-5) = <76 score (Kelly et al., 2008) [lower scores indicate worse well-being]);
- •Proficient in Dutch;
- •willing to try out the app for about 2 hours per week during 6 weeks and fill in the questionnaires for 8-10 weeks;
- •Participants should have a smartphone, computer or tablet with internet access for digital intervention and data-collection.
排除标准
- •1. Participants have a current psychological or psychiatric treatment outside this study.
- •Insufficient Dutch language skills to follow the group sessions or complete homework exercises
研究组 & 干预措施
Digital self-help self-compassion app (Compas-Y)
6-week self-help app intervention
干预措施: A digital self-help self-compassion app intervention (Other)
结局指标
主要结局
Self-compassion
时间窗: During baseline period, participants fill out 3 assessments each week on Tuesday, Thursday and Saturday at 7.00 PM for 2 to 3 weeks (depending on randomisation). During the 6-week intervention, they will fill out 3 assessments each week.
Momentary self-compassion is assessed using ecological momentary assessment (EMA) items. We use five items based on the Sussex-Oxford Compassion for the Self Scale (SOCS-S), with each of the five facets of self-compassion covered by one EMA item: (1) "I'm quick to notice early signs of distress in myself.", (2) "I understand that feeling upset at times is part of human nature.", (3) "I feel kindly towards myself.", (4) "I connect with my own suffering without judging myself.", (5) "I try to look after myself." Items are rated on a 0-100 visual analogue scale with verbal anchors (0 = "Not at all," 25 = "A little," 50 = "Moderately," 75 = "Quite a bit," 100 = "Very much").
Self-criticims
时间窗: During baseline period, participants fill out 3 assessments each week on Tuesday, Thursday and Saturday at 7.00 PM for 2 to 3 weeks (depending on randomisation). During the 6-week intervention, they will fill out 3 assessments each week.
Momentary self-criticism is assessed with a single item derived from the Self-Compassion Scale: "I am a bit cold-hearted towards myself when I'm experiencing suffering", rated on a 0-100 visual analogue scale with verbal anchors (0 = "Not at all," 25 = "A little," 50 = "Moderately," 75 = "Quite a bit," 100 = "Very much").
次要结局
- Mindfulness(During baseline period, participants fill out 3 assessments each week on Tuesday, Thursday and Saturday at 7.00 PM for 2 to 3 weeks (depending on randomisation). During the 6-week intervention, they will fill out 3 assessments each week.)
- Affect(During baseline period, participants fill out 3 assessments each week on Tuesday, Thursday and Saturday at 7.00 PM for 2 to 3 weeks (depending on randomisation). During the 6-week intervention, they will fill out 3 assessments each week.)
- Emotion regulation(During baseline period, participants fill out 3 assessments each week on Tuesday, Thursday and Saturday at 7.00 PM for 2 to 3 weeks (depending on randomisation). During the 6-week intervention, they will fill out 3 assessments each week.)