Traditional Chinese Medicine Health Preservation Intervention for Depression: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 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 aims to evaluate the feasibility and preliminary effects of Traditional Chinese Medicine (TCM) health preservation for depression on depressive symptoms reduction and other health-related outcomes among Hong Kong Chinese adults with depression. Participants in intervention group will receive TCM health preservation course for six weeks (6 sessions, 2 hours each) and practice TCM health preservation during the 6-week follow-up period. Participants in the control group (waitlist control) will receive usual care. After the follow-up assessment, TCM health preservation courses for depression will be provided to them for compensation.
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)
盲法说明
The researchers who perform the outcome measurement and those researchers who conduct data analysis will be blinded to group allocation.
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 Chinese adults aged 18-years-old to 65-years-old;
- •diagnosed with moderate level of depression (a score of 10~20), evaluated by the Patient Health Questionnaire-9 (PHQ-9);
- •can communicate in spoken Cantonese and written Chinese;
- •willing to provide written informed consent and be able to adhere to the study protocol.
排除标准
- •being pregnant or during the lactation, or plan to get pregnant;
- •new onset or change of antidepressant medication or dosage in the last 3 months;
- •PHQ-9 score≥20, meaning a severe level of depression;
- •with a previous or present diagnosis of psychotic disorders as screened by the Chinese version of the Structured Clinical Interview for DSM-IV;
- •the score of Hong Kong Montreal Cognitive Assessment less than 22;
- •significant suicidal risk as rated by the Hamilton Depression Rating Scale item on suicide (score ≥3);
- •with diagnosis of illness which can interfere the individuals to participate or adhere to the modified lifestyle;
- •with diagnosis of medical conditions, which are not suitable to modify diet or do physical activities recommended by physicians;
- •joining in another clinical trial during the study period;
- •with any major medical condition that causes depression based on the judgement of the investigator.
结局指标
主要结局
Change in the Patient Health Questionnaire (PHQ-9)
时间窗: Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12
The PHQ-9, a self-rated questionnaire to assess the presence and severity of depressive symptoms of an individual during the last 2 weeks on a scale of 0 (not at all) to 3 (nearly every day), with a total score ranging from 0 to 27. A higher score indicates a higher severity of depression symptoms.
次要结局
- Change in the Generalized Anxiety Disorder-7 (GAD-7)(Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12)
- Change in the Fatigue Assessment Scale (FAS)(Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12)
- Change in the Perceived Stress Scale (PSS-10)(Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12)
- Change in the Insomnia Severity Index (ISI)(Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12)
- Change in the Short-Form (six-dimension) Health Survey (SF-6D)(Time Frame: Baseline, week 6, week 8, week 12)
- Change in the General Self-Efficacy Scale (GSE)(Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12)
- Change in the Health-Promoting Lifestyle Profile II (HPLP II)(Time Frame: Baseline, week 4, week 6, week 8, week 12)