Self-administered Acupressure for Depression: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Patient Health Questionnaire (PHQ)
研究概览
简要总结
The goal of this clinical trial is to examine the effects of self-administered acupressure intervention for alleviating depressive symptoms among people with depression. It is hypothesized that the self-administered acupressure group would have a great improvement in depressive symptoms as measured by the Patient Health Questionnaire compared with the mental health education group across the 12-week intervention period.
The main questions it aims to answer are:
- Is the self-administered acupressure intervention more effective for alleviating depression and other related outcomes compared to the mental health education group among depressed individuals?
- Is the self-administered acupressure intervention acceptable and feasible for depressed individuals to alleviate depression? Participants will be randomized into self-administered acupressure group or mental health education group based on the group allocation with a 1:1 ratio. Participants will attend two weekly 120-min self-administered acupressure training or mental health education, respectively.
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 assessment and 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 residents aged 18 to 65
- •Can communicate in Cantonese and comprehend written Chinese
- •Have moderate or above-level depression as measured by the PHQ-9 with a score of 10 or above
- •Willing to give informed consent and comply with the trial protocol.
排除标准
- •Have the PHQ score of 20 or above (referral information to community psychological services will be provided)
- •New onset or change of antidepressant medication or dosage in the last 3 months
- •Previous or current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder as screened using the Chinese version of the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders.
- •Have cognitive impairment diagnosed by the Hong Kong Montreal Cognitive Assessment with a score < 22
- •Skin lesions or infections at the treatment sites
- •Significant suicidal risk as rated by the Hamilton Depression Rating Scale item on suicide (score ≥3)
- •Pregnant or childbearing potential but not using adequate contraception
- •With any major medical condition that causes depression based on the judgement of a psychiatrist.
研究组 & 干预措施
Self-administered acupressure group
The participants in the self-administered acupressure group will attend an acupressure training course (2 sessions, 2 h each) to learn self-administered acupressure from an acupuncturist in a classroom at the School Nursing, the Hong Kong Polytechnic University. Each class will be conducted in a small group of 4 to 7 participants to enhance interaction and ensure the quality of teaching. Participants will then practice two times a day for 8 weeks.
干预措施: Self-administered acupressure group (Behavioral)
Mental health education group
The participants in the comparison group will receive mental health education group from a registered nurse with the same frequency as those in the treatment group (2 sessions, 2 h each) in a classroom at the School Nursing, the Hong Kong Polytechnic University, and will be reminded to follow the mental health practice daily for 8 weeks.
干预措施: Mental health education group (Behavioral)
结局指标
主要结局
Patient Health Questionnaire (PHQ)
时间窗: It will be measured at week 12 from baseline
The PHQ-9, a self-rated questionnaire to assess depressive symptoms over 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.
次要结局
- The Short-Form (six-dimension) Health Survey (SF-6D)(It will be measured at week 12 from baseline)
- The Depression Anxiety Stress Scales (DASS-21) - Stress(It will be measured at week 12 from baseline)
- The Insomnia Severity Index (ISI)(It will be measured at week 12 from baseline)
- Hamilton Depression Rating Scale (HDRS)(It will be measured at week 12 from baseline)
- The Depression Anxiety Stress Scales (DASS-21) - Anxiety(It will be measured at week 12 from baseline)