Lifestyle Medicine for Depression: 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 Patient Health Questionnaire (PHQ-9)
研究概览
简要总结
This study will examine the feasibility and efficacy of lifestyle medicine for the enhancement of psychological wellness in adult. The main components of lifestyle intervention typically include physical activity, diet, relaxation/mindfulness, sleep and socialisation. These components are weaved with psychological elements such as stress management, cognitive restructuring, motivational interviewing, and goal setting strategies that are led by clinical psychologists. While lifestyle medicine has been recognised for centuries a a mean to improve physical health, the field of lifestyle medicine in the context of mental health is still in its infancy. Nevertheless, there is increasing evidence demonstrating the efficacy of individual components of lifestyle medicine (e.g. diet, physical activities, and sleep) on mood and stress management. With a well-researched lifestyle medicine programme adopted from Australia, the research team of the Chinese University of Hong Kong has customised the intervention protocol to fit the Chinese culture.
The investigators aim to examine the effectiveness of an integration of multiple lifestyle adjustments on depression from a holistic body-mind perspective.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hong Kong residents aged ≥ 18 years;
- •Cantonese language fluency;
- •Patient Health Questionnaire (PHQ-9) score ≥ 10; and
- •Willingness to provide informed consent and comply with the trial protocol
排除标准
- •Pregnancy;
- •Have suicidal ideation with PHQ-9 item 9 score ≥ 2 (referral information to professional services will be provided to those who endorsed items on suicidal ideation);
- •Using medication or psychotherapy for depression;
- •Having unsafe conditions and are not recommended for physical activity or a change in diet by physicians; and
- •Have major psychiatric, medical or neurocognitive disorders that make participation infeasible or interfere with the adherence to the lifestyle intervention
结局指标
主要结局
Change in the Patient Health Questionnaire (PHQ-9)
时间窗: Baseline, 1-week post-treatment and 12-week 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).
次要结局
- Change in the Depression Anxiety Stress Scales (DASS-21)(Baseline, 1-week post-treatment and 12-week post treatment)
- Change in the Short Form (Six-Dimension) Health Survey (SF-6D)(Baseline, 1-week post-treatment and 12-week post treatment)
- Change in the Insomnia Severity Index (ISI)(Baseline, 1-week post-treatment and 12-week post treatment)
- Change in the Health-Promoting Lifestyle Profile (HPLP II)(Baseline, 1-week post-treatment and 12-week post treatment)
- Change in the Sheehan Disability Scale (SDS)(Baseline, 1-week post-treatment and 12-week post treatment)
- Change in the Credibility-Expectancy Questionnaire (CEQ)(Baseline and 1-week post-treatment)
研究者
Fiona YY Ho
Assistant Professor
Chinese University of Hong Kong