Effect of a Culturally Adapted Self-help Smartphone-based Lifestyle Intervention in Reducing Depressive and Anxiety Symptoms: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Change in the Patient Health Questionnaire (PHQ-9)
研究概览
简要总结
This study will examine the effects of smartphone-based lifestyle medicine (LM) for alleviating depressive and anxiety symptoms in Chinese population. Since a range of lifestyle factors are involved in the pathogenesis and progression of depression and anxiety, modifying different lifestyle factors simultaneously, for example, diet, exercise, stress and sleep which are empirically supported by previous reviews, may be effective to reduce depressive and anxiety symptoms. Traditional Chinese medicine concepts will be integrated into the app to increase the acceptability towards mental health treatment. Through this study, we aim to promote evidence-based patient care and to improve help-seeking and access to evidence-based interventions for depression and anxiety.
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 reducing depressive and anxiety symptoms in Chinese population. Prior to all study procedures, eligible participants will be required to complete an online informed consent (with telephone support). With an estimation of 30% withdrawal, around 124 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
- 否
入选标准
- •Hong Kong residents
- •Aged ≥ 18 years
- •Have a Patient Health Questionnaire (PHQ-9) score ≥ 10 or Generalized Anxiety Disorder 7-Item Scale (GAD-7) ≥ 8
- •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
- •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 Patient Health Questionnaire (PHQ-9)
时间窗: Baseline, immediately post-treatment and 1-month post treatment
The PHQ-9, a 9-item questionnaire used for screening, diagnosing, monitoring and measuring the severity of depression, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day).
Change in the Generalized Anxiety Disorder 7-Item Scale (GAD-7)
时间窗: Baseline, immediately post-treatment and 1-month post treatment
The GAD-7, a 7-item questionnaire used for screening, diagnosing, monitoring and measuring the severity of anxiety over the past two weeks on a 4-point scale, "0" (not at all) to "4" (nearly every day).
次要结局
- 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 International Physical Activities Questionnaire - Chinese version (IPAQ-C) (Lai et al., 2018; Macfarlane, Lee, Ho, Chan, & Chan, 2007)(Baseline, immediately post-treatment and 1-month post treatment)
- Change in the Health-Promoting Lifestyle Profile (HPLP II)(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 Short Form (Six-Dimension) Health Survey (SF-6D)(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)
- Self-developed survey(Baseline)
研究者
Fiona YY Ho
Assistant Professor
Chinese University of Hong Kong