An Awareness, Courage, and Love Intervention to Help Chinese Older Adults in the Post-pandemic Era: A Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Changes from Baseline on the Inclusion of Others in Self (IOS) at Immediately post-intervention and One-month post-intervention follow-up
研究概览
简要总结
The purpose of this study is to explore the potential effectiveness of a one-session online Awareness, Courage, and Love intervention for reducing loneliness, depression and anxiety symptoms, and enhancing social connectedness and subjective well-being among older adults. the study also aims to estimate the effect sizes of the Awareness, Courage, and Love intervention.
详细描述
The recruitment process will commence with referrals from local community organizations. Eligible individuals will be provided with detailed information about the study, and informed consent will be obtained from those willing to participate. After the confirmation of participant recruitment, a randomization process will be implemented to ensure the equitable distribution of participants between the intervention and waitlist control groups. An independent researcher will generate computer-generated random codes for group assignment, and these codes will be securely sealed in opaque envelopes. The envelopes will be sequentially numbered, and the randomization process will remain blinded throughout to prevent bias. Participants will be notified via email or text for the details of the condition they are assigned, and their willingness to engage in both the intervention and data collection will be confirmed.
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
- Single (Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged 60 years or older and dwelling in the community;
- •able to communicate in Cantonese;
- •have access to the internet and videoconferencing devices such as a mobile phone;
- •able to give informed consent to participate.
排除标准
- •severe emotional distress based on PHQ-4 screening assessment or presenting an imminent suicidal risk;
- •known history of autism, intellectual disability, schizophrenia-spectrum disorder, bipolar disorder, Parkinson's disease, or dementia/significant cognitive impairment;
- •illiterate;
- •difficulty in communication.
结局指标
主要结局
Changes from Baseline on the Inclusion of Others in Self (IOS) at Immediately post-intervention and One-month post-intervention follow-up
时间窗: Baseline, Immediately post-intervention and One-month post-intervention follow-up
The single-item Inclusion of Others in the Self (IOS) scale is to measure how close the respondent feels with another person or group. Respondents choose a pair of photos from seven with different degrees of overlap. Possible scores range from 1 (No overlap) to 7 (Most overlap).
次要结局
- Changes from Baseline on the 6-item de Jong Gierveld loneliness scale at Immediately post-intervention and One-month post-intervention follow-up(Baseline, Immediately post-intervention and One-month post-intervention follow-up)
- Changes from Baseline on the Patient Health Questionnaire (PHQ-9) at Immediately post-intervention and One-month post-intervention follow-up(Baseline, Immediately post-intervention and One-month post-intervention follow-up)
- Changes from Baseline on the Generalized Anxiety Disorder 2-item (GAD-2) at Immediately post-intervention and One-month post-intervention follow-up(Baseline, Immediately post-intervention and One-month post-intervention follow-up)
- Changes from Baseline on The World Health Organisation- Five Well-Being Index (WHO-5) at Immediately post-intervention and One-month post-intervention follow-up(Baseline, Immediately post-intervention and One-month post-intervention follow-up)
研究者
Stephen Cheong Yu Chan
Assistant Professor
Caritas Institute of Higher Education