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Comparing Acupuncture With Medication to Reduce Depression, Anxiety and Comorbid Sleep Disorders in China

Comparing Acupuncture With Medication to Reduce Depression, Anxiety and Comorbid Sleep Disorders in China

Recruiting
18-65 years
All
Phase 4

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Overview

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.

Description

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.

Eligibility

Inclusion Criteria:

  1. Chinese nationals 18-65 years old
  2. At least one of the screening scores below suggestive of depression/anxiety tendencies:
    1. Depressive state: Depression Self-Rating Scale (SDS) raw score ≥43; standard score ≥53 (27)
    2. Anxiety state: Anxiety Self-Rating Scale (SAS) raw score ≥40; standard score ≥50 (28) Note: (standard score = raw score X 1.25)

Exclusion Criteria:

  1. Patients with severe comorbid physical illnesses that prevent them from completing the full course of treatment;
  2. Patients with a risk of suicide;
  3. Patients with a history of head trauma, loss of consciousness, or severe mental disorders;
  4. Patients with drugs or alcohol abuse;
  5. Patients who have received physical treatment methods within the past 3 months;
  6. Patients who have received antidepressant or antipsychotic medication treatment within the past 3 months;
  7. Patients with severe skin lesions or skin diseases.

Study details
    Anxiety Depression
    Sleep

NCT07552246

Duke Kunshan University

1 August 2026

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