Effect of a Culturally Adapted Self-help Smartphone-based Lifestyle Intervention in Improving Psychological Well-being: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in the Depression Anxiety Stress Scales-21
研究概览
简要总结
This study will examine the effects of a smartphone-based lifestyle medicine (LM) for improving psychological well-being in Chinese population. Since a range of lifestyle factors are involved in the pathogenesis and progression of common mental disorders (e.g., depression and anxiety), modifying different lifestyle factors simultaneously may be effective to improve our psychological well-being. Chinese dietary recommendations will be integrated into the app to increase the acceptability towards mental health intervention. Through this study, we aim to promote evidence-based patient care and to improve help-seeking and access to evidence-based interventions for improving psychological well-being.
详细描述
This study will be a randomized controlled trial on the effects of a culturally adapted self-help smartphone-based lifestyle medicine for improving psychological well-being in Chinese population. Prior to all study procedures, eligible participants will be required to complete an online informed consent (with telephone support). Around 30 eligible participants will be randomly assigned to either smartphone-based lifestyle medicine (LM group) or the waitlist control group (WL group) in a ratio of 1:1.
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
- Single (Outcomes Assessor)
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
- •Hong Kong residents
- •Aged ≥ 18 years
- •Able to read Chinese and type in Chinese or English
- •Have an Internet-enabled mobile device (iOS or Android operating system)
- •Are willing to provide informed consent and comply with the trial protocol
排除标准
- •Have a Patient Health Questionnaire (PHQ-9) score ≥ 10
- •Have a Generalized Anxiety Disorder 7-Item Scale (GAD-7) ≥ 8
- •Current involvement in psychotherapy or unstable medication for depression and/or anxiety
- •Beck Depression Inventory (BDI-II) Item 9 score of at least 2 indicating a current moderate suicidal risk that requires active crisis management (referral information to professional services will be provided to those with serious suicidal risk)
- •Are having unsafe conditions and are not recommended for physical activity or a change in diet by physicians
- •Having major psychiatric, medical or neurocognitive disorders that make participation infeasible or interfere with the adherence to the lifestyle modification
结局指标
主要结局
Change in the Depression Anxiety Stress Scales-21
时间窗: Immediately post-treatment and 1-month post treatment
DASS-21 is a 21-items scale, comprises of three sub-scales which measures the negative emotional states of depression, anxiety, and stress, over the past week. The DASS is based on a dimensional rather than a categorical conception of psychological disorder, thus it has no direct implications for the allocation of patients to discrete diagnostic categories. However, recommended cutoff scores for conventional severity labels (normal, moderate, severe) are given in the DASS Manual.
次要结局
- Change in the Health-Promoting Lifestyle Profile (HPLP II)(Baseline, immediately post-treatment and 1-month post treatment)
- Change in the Short Form (Six-Dimension) Health Survey (SF-6D)(Baseline, immediately post-treatment and 1-month post treatment)
- Change in The Insomnia Severity Index (ISI)(Baseline, immediately post-treatment and 1-month post treatment)
- Change in the Sheehan Disability Scale (SDS)(Baseline, immediately post-treatment and 1-month post treatment)
- Change in the Credibility-Expectancy Questionnaire (CEQ)(Baseline, immediately post-treatment and 1-month post treatment)
- Change in the Food Frequency Questionnaires (FFQs)(Baseline, immediately post-treatment and 1-month post treatment)
- Change in the International Physical Activities Questionnaire - Chinese version (IPAQ-C)(Baseline, immediately post-treatment and 1-month post treatment)
- Self-developed survey(Baseline)
研究者
Fiona YY Ho
Assistant Professor
Chinese University of Hong Kong