Traditional Chinese Medicine Health Preservation Intervention for Depression: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 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.
研究组 & 干预措施
traditional Chinese medicine health preservation group
The participants in the traditional Chinese medicine health preservation group will attend six traditional Chinese medicine health preservation courses (2h each per one, for 6 weeks) to learn and experience traditional Chinese medicine health preservation from a registered traditional Chinese medicine practitioner in a classroom at the School Nursing, the Hong Kong Polytechnic University.
Each class will be conducted in a small group of 4 to 6 participants to enhance interaction and ensure the quality of teaching. Participants will then practice traditional Chinese medicine health preservation at home for 6 weeks.
干预措施: Waitlist control group (Behavioral)
traditional Chinese medicine health preservation group
The participants in the traditional Chinese medicine health preservation group will attend six traditional Chinese medicine health preservation courses (2h each per one, for 6 weeks) to learn and experience traditional Chinese medicine health preservation from a registered traditional Chinese medicine practitioner in a classroom at the School Nursing, the Hong Kong Polytechnic University.
Each class will be conducted in a small group of 4 to 6 participants to enhance interaction and ensure the quality of teaching. Participants will then practice traditional Chinese medicine health preservation at home for 6 weeks.
干预措施: Traditional Chinese Medicine health preservation group (Behavioral)
Waitlist control group
Participants in the waitlist control group will receive usual care during the 6-week waitlist period of intervention, and 6-week waitlist period of follow-up. After the follow-up assessment, they will be provided an equivalent traditional Chinese medicine health preservation for depression.
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 Health-Promoting Lifestyle Profile II (HPLP II)(Time Frame: Baseline, week 4, week 6, week 8, week 12)
- 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 General Self-Efficacy Scale (GSE)(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)