Smartphone-Delivered Lifestyle Medicine Intervention for Generalized Anxiety Symptoms: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in the Generalized Anxiety Disorder-7 (GAD-7)
研究概览
简要总结
This study will examine the effects of smartphone-based lifestyle medicine for alleviating generalised anxiety symptoms in Chinese population. Since a range of lifestyle factors are involved in the pathogenesis and progression of generalised anxiety disorder ( Cox & Olatunji, 2016; Dale et al., 2014; Vøllestad et al., 2012), modifying different lifestyle factors simultaneously, for examples, diet, exercise, stress and sleep, may be effective to reduce generalised anxiety symptoms. Recent studies indicate that service users are showing an increasing interest in self-help interventions for common mental disorders because of their accessibility and low cost (Marshall et al., 2021; Weisel et al., 2019). Nonetheless, to date, only limited self-help interventions that target lifestyle medicine for generalised anxiety symptoms are available.
This study will be a randomised controlled trial on the effects of a self-help smartphone-based lifestyle medicine intervention for reducing generalised anxiety symptoms in Chinese population. Prior to all study procedures, eligible participants will be required to complete an online informed consent (with telephone support). Around 50 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. The randomization will be performed by an independent assessor using a computer-generated list of numbers. Participants in the LM group will receive the multicomponent lifestyle medicine intervention via the app for 8 weeks, whilst the WL control group will receive the intervention after trial completion. The primary outcomes will be the level of generalised anxiety symptoms at immediate and 3-month post-intervention assessments; while the secondary outcomes will be the level of depressive symptoms, insomnia symptoms, physical activity, health-related quality of life, functional impairment, health-promoting behaviours, and intervention acceptability at immediate and 3-month post-intervention assessments.
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
- •Have a Generalized Anxiety Disorder-7 (GAD-7) score ≥ 8
- •Able to read Chinese and type in Chinese or English
- •Have an Internet-enabled mobile device (iOS or Android operating system)
- •Willing to provide informed consent and comply with the trial protocol
排除标准
- •Current involvement in psychotherapy or recent changes in medication for anxiety
- •A Patient Health Questionnaire-9 (PHQ-9) item 9 score > 2, indicating a serious level of suicidal risk (referral information to professional mental health services will be provided)
- •Self-disclosure of having unsafe health conditions for which physical activity or a change in diet was contraindicated by physicians
- •Self-disclosure of a diagnosis of any major psychiatric, medical or neurocognitive disorders that make participation unsuitable or that may interfere with the adherence to the lifestyle modifications
结局指标
主要结局
Change in the Generalized Anxiety Disorder-7 (GAD-7)
时间窗: Baseline, immediate post-intervention, and 3-month post-intervention
GAD-7 is a seven-item scale for assessing the level of generalized anxiety in the past two weeks. It comprises questions related to feelings of anxious and worry in daily lives. This four-point Likert scale is rated from 0 (not at all) to 3 (almost everyday), and the cut off score on the sum of each item will be the standard to differentiate the anxiety level (5, 10, 15 correspond to mild, moderate and severe respectively)
次要结局
- Change in the Short Form (Six-Dimension) Health Survey (SF-6D)(Baseline, immediate post-intervention, and 3-month post-intervention)
- Change in the Treatment Acceptance Questionnaire (TAQ)(Baseline and immediate post-intervention)
- Change in the Patient Health Questionnaire (PHQ-9)(Baseline, immediate post-intervention, and 3-month post-intervention)
- Change in the Health-Promoting Lifestyle Profile (HPLP II)(Baseline, immediate post-intervention, and 3-month post-intervention)
- Change in the Sheehan Disability Scale (SDS)(Baseline, immediate post-intervention, and 3-month post-intervention)
- Change in the Credibility-Expectancy Questionnaire (CEQ)(Baseline and immediate post-intervention)
- Change in the International Physical Activities Questionnaire-Chinese version (IPAQ-C)(Baseline, immediate post-intervention, and 3-month post-intervention)
- Change in the Insomnia Severity Index (ISI)(Baseline, immediate post-intervention, and 3-month post-intervention)
研究者
Fiona YY Ho
Assistant Professor
Chinese University of Hong Kong