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 management of depression in Chinese adult population. The main components of lifestyle intervention typically include physical activity, diet, relaxation/mindfulness, and sleep. While lifestyle medicine has been recognized for centuries as a means to improve physical health, the field of lifestyle medicine in the context of mental health is still in its infancy. In the existing literature, there is increasing evidence demonstrating the efficacy of individual components of lifestyle medicine (e.g, physical activities and sleep) on depression. However, there is very limited research on the effectiveness of an integration of multiple lifestyle adjustments on depression.
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;
- •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
- •Have suicidal ideation based on Beck Depression inventory (BDI-II) 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 exercising 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 modification.
研究组 & 干预措施
Treatment Group
lifestyle medicine group
干预措施: Lifestyle Medicine (Behavioral)
CAU group
Care-As-Usual group
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 20-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 Depression Anxiety Stress Scales (DASS-21)(Baseline, 1-week post-treatment and 12-week post treatment)
- Change in Insomnia Severity Index (ISI)(Baseline, 1-week post-treatment and 12-week post treatment)
- Change in Multidimensional Fatigue Inventory (MFI)(Baseline, 1-week post-treatment and 12-week post treatment)
- Change in Sheehan Disability Scale (SDS)(Baseline, 1-week post-treatment and 12-week post treatment)
- Change in Short form Health Survey - 36 items (SF-36)(Baseline, 1-week post-treatment and 12-week post treatment)
研究者
Fiona YY Ho
Assistant Professor
Chinese University of Hong Kong