Comparing Acupuncture With Medication to Reduce Depression, Anxiety and Comorbid Sleep Disorders in China: A Preference-based Trial Comparing Clinical Efficacy, Cost-effectiveness and Environmental Footprint
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Between-groups and within-subjects mean change in depression
研究概览
简要总结
The main objective of this study is to compare medication (usual care; active comparator) with acupuncture (as experimental intervention) to identify the most (cost)effective and environmentally sustainable intervention to reduce depression, anxiety and comorbid sleep disorders in adults (18-65) in China.
详细描述
The main objective of this study is to compare medication (usual care; active comparator) with acupuncture (as experimental intervention) to identify the most (cost)effective and environmentally sustainable intervention to reduce depression, anxiety and comorbid sleep disorders in adults (18-65) in China.
In recent years, there has been a growing focus on how to alleviate emotional distress and promote psychological well-being, prompting researchers to find the most effective treatment from a clinical perspective. At the same time, the healthcare system is also facing financial pressures and environmental sustainability challenges, which requires multiple factors to be considered when choosing patient care options. Therefore, this project intends to compare the clinical efficacy, cost-effectiveness, and environmental footprint of acupuncture versus medication in alleviating anxiety and depressive symptoms in Chinese adults (aged 18 years and above). These analyses provide the necessary basis for the development of rigorous evidence-based policy recommendations.
The World Health Organization (WHO) and the "Healthy China 2030" Plan Outline both attach great importance to integrating the traditional Chinese medicine (TCM) system into the overall medical system. As an important part of TCM, acupuncture is included in the WHO Traditional Medicine Strategy and is encouraged to play a more mainstream role in healthcare treatments. However, neither WHO nor Healthy China 2030 have yet to clarify the role of acupuncture in the specific field of mental health.
This lack of rigorous scientific evidence related to mental health, and acupuncture in particularly, co-exists with the broader growing focus on "complementary and alternative medicine" (CAM), which includes acupuncture, other forms of traditional Chinese medicine and other traditional medicine systems worldwide. CAM and Western medicine differ significantly in terms of concepts, methods, and resource use. CAM is often hypothesized to have a low direct environmental impact due to the use of natural ingredients and the emphasis on prevention, but its actual environmental footprint still needs to be rigorously evaluated. If the efficacy is insufficient (which is often also hypothesized to be the case), it may prolong the course of the disease, increase patient suffering, financial burden and environmental footprint. At present, CAM mainly shows validated efficacy in physical health. For example, some studies have shown that acupuncture has certain effects in relieving chronic lower back pain and arthritis pain. Mind-body practices such as meditation and yoga also have a positive impact on cardiovascular health, such as lowering blood pressure and improving respiratory efficiency.
However, in the field of mental health, relevant research is insufficient. The available evidence is often methodologically limited and limited by research bias based on Western samples, making it difficult to fully assess the global applicability of CAM. Although there is preliminary evidence that acupuncture may have positive effects on mental health, there is still a lack of systematic comparative studies, especially direct comparisons with mainstream Western therapies and differences in their environmental effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Chinese nationals 18-65 years old
- •At least one of the screening scores below suggestive of depression/anxiety tendencies:
- •Depressive state: Depression Self-Rating Scale (SDS) raw score ≥43; standard score ≥53 (27)
- •Anxiety state: Anxiety Self-Rating Scale (SAS) raw score ≥40; standard score ≥50 (28) Note: (standard score = raw score X 1.25)
排除标准
- •Patients with severe comorbid physical illnesses that prevent them from completing the full course of treatment;
- •Patients with a risk of suicide;
- •Patients with a history of head trauma, loss of consciousness, or severe mental disorders;
- •Patients with drugs or alcohol abuse;
- •Patients who have received physical treatment methods within the past 3 months;
- •Patients who have received antidepressant or antipsychotic medication treatment within the past 3 months;
- •Patients with severe skin lesions or skin diseases.
研究组 & 干预措施
Acupuncture
Acupuncture Points Selected: Bilateral Baihui (GV20), Yintang (GV29), Anmian (EX-HN22), Shenmen (HT7), Neiguan (PC6), Sanyinjiao (SP6), Zhaohai (KI6), Shenmai (BL62), and Taichong (LR3)
干预措施: Acupuncture (Other)
结局指标
主要结局
Between-groups and within-subjects mean change in depression
时间窗: Collected at baseline T0, after intervention T1 (after 3-4 weeks intervention), and at 3-month follow-up T2.
Changes in depression will be measured with Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a versatile tool for screening, diagnosing, monitoring, and assessing depression severity. The prompt instruction is: Over the last 2 weeks, how often have you been bothered by any of the following problems? Example of items: "Little interest or pleasure in doing things"; "Feeling down, depressed, or hopeless". Scoring options include: 0=not at all, 1=several days, 2=more than half of the days, 3=nearly every day. Lower mean values suggest aggregate reductions in depression.
Between-groups and within-subjects mean change in anxiety
时间窗: Collected at baseline T0, after intervention T1 (after 3-4 weeks intervention), and at 3-month follow-up T2.
Change in anxiety will be measured with the Generalised Anxiety Disorder Assessment (GAD-7). GAD-7 is a brief measure for symptoms of anxiety, based on the generalised anxiety disorder (GAD) diagnostic criteria described in the Diagnostic and Statistical Manual of Mental Disorders (DSM). The prompt instruction is: Over the last 2 weeks, how often have you been bothered by any of the following problems? Example of items: "Feeling nervous, anxious, or on edge"; "Not being able to stop or control worrying". Scoring options include: 0=not at all, 1=several days, 2=more than half of the days, 3=nearly every day. Lower mean values suggest aggregate reductions in anxiety.
Between-groups and within-subjects mean change in depression
时间窗: Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3).
Changes in depression will be measured with Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a versatile tool for screening, diagnosing, monitoring, and assessing depression severity. The prompt instruction is: Over the last 2 weeks, how often have you been bothered by any of the following problems? Example of items: "Little interest or pleasure in doing things"; "Feeling down, depressed, or hopeless". Scoring options include: 0=not at all, 1=several days, 2=more than half of the days, 3=nearly every day. Lower mean values suggest aggregate reductions in depression.
Between-groups and within-subjects mean change in anxiety
时间窗: Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3).
Change in anxiety will be measured with the Generalised Anxiety Disorder Assessment (GAD-7). GAD-7 is a brief measure for symptoms of anxiety, based on the generalised anxiety disorder (GAD) diagnostic criteria described in the Diagnostic and Statistical Manual of Mental Disorders (DSM). The prompt instruction is: Over the last 2 weeks, how often have you been bothered by any of the following problems? Example of items: "Feeling nervous, anxious, or on edge"; "Not being able to stop or control worrying". Scoring options include: 0=not at all, 1=several days, 2=more than half of the days, 3=nearly every day. Lower mean values suggest aggregate reductions in anxiety.
Between-groups and within-subjects mean change in sleep condition
时间窗: Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3).
Changes in sleep will be measured with Sleep Condition Indicator (SCI). The Sleep Condition Indicator (SCI) is an eight-item rating scale that was developed to screen for insomnia disorder based on DSM-5 criteria. It has been shown previously to have good psychometric properties among several language translations. The prompt instruction is: Thinking about a typical night in the last month... Example of items: "How long does it take you to fall asleep?"; "How would you rate your sleep quality?". Scoring options from 0 to 4, SCI total from minimum 0 to maximum 32; a higher score means better sleep.
次要结局
- Between-groups Comparative Environmental Footprint(After treatment is concluded (Time 1) and 3-months follow-up (Time 2))
- Between-groups Comparative Cost-Effectiveness(After treatment is concluded (Time 1) and at 3-months follow-up (Time 2))
- Between-groups and within-subjects mean change in Side Effects(Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3).)
研究者
Claudia Nisa
Assistant Professor of Behavioral Science
Duke Kunshan University