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: A Preference-based Trial Comparing Clinical Efficacy, Cost-effectiveness and Environmental Footprint

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep; Anxiety Depression
• Intervention / Treatment: Drug: Psychotropic Drugs; Other: Acupuncture

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Claudia F. Nisa; Phone Number: 008618151144079; Email: claudia.nisa@duke.edu

Study Locations

• China
  • Jiangsu
    • Kunshan, Jiangsu, China
      • Recruiting
      • Kunshan Mental Health Center and Kunshan Hospital of Traditional Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Psychotropic Drugs; Trazodone (25-150 mg; once daily, 30 minutes before bedtime) or mirtazapine (3.75-30 mg; once daily, 30 minutes before bedtime); Zopiclone (5-10 mg; once daily, taken at bedtime) or lorazepam (0.25-1 mg, once daily, taken at bedtime) Patients may also be prescribed 3. Escitalopram oxalate tablets (10-20 mg; once daily, 30 minutes after breakfast) in cases where Insomnia is Caused by Depressive and Anxious Symptoms	Drug: Psychotropic Drugs; Trazodone (25-150 mg; once daily, 30 minutes before bedtime) or mirtazapine (3.75-30 mg; once daily, 30 minutes before bedtime); Zopiclone (5-10 mg; once daily, taken at bedtime) or lorazepam (0.25-1 mg, once daily, taken at bedtime) Patients may also be prescribed 3. Escitalopram oxalate tablets (10-20 mg; once daily, 30 minutes after breakfast) in cases where Insomnia is Caused by Depressive and Anxious Symptoms The treatment is planned for 4 weeks. After 2 weeks, patients are invited for a check-in visit but there will be no change in the treatment prescribed for 4 weeks
Experimental: 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)	Other: Acupuncture; Manual acupuncture (no sham) will be compared to medication. Acupuncture Points Selected: Bilateral Baihui (GV20), Yintang (GV29), Anmian (EX-HN22), Shenmen (HT7), Neiguan (PC6), Sanyinjiao (SP6), Zhaohai (KI6), Shenmai (BL62), and Taichong (LR3) (29, 30) Operational Procedure: Patient Position: Supine position.; Needles: Single-use sterile needles (Specifications: 0.25 mm × 40 mm; Brand: Wuxi Jiajian).; Disinfection: Strict disinfection protocols must be performed prior to needling.; Needling Technique: After insertion, lifting-thrusting and twirling-rotating manipulation techniques are applied to elicit De Qi (the arrival of Qi).; Needle Retention Time: 20 minutes.; Treatment Regimen:Frequency: 3 sessions per week (Monday, Wednesday, and Friday).Course of Treatment: 9 to 10 sessions per course.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Between-groups and within-subjects mean change in depression	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.	Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3).
Between-groups and within-subjects mean change in anxiety	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.	Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3).
Between-groups and within-subjects mean change in sleep condition	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.	Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Between-groups Comparative Environmental Footprint	To calculate the comparative environmental impacts of acupuncture versus antidepressants to reduce postpartum depression, we will consider a range of factors including list of resources, quantities used (e.g., electricity, water), emissions factors and indirect emissions e.g., supply chain. We will follow validated calculation methods for healthcare, which will allow to identify, measure and evaluate the total emission impacts of different health treatments. This calculation will document all resources used in both arms of the trial, including medications, acupuncture materials, travel, infrastructure use (e.g., clinic space), and any other resources engaged during the trial. Both treatments have waste that must be managed. We will normalize the footprint data per patient or per unit of clinical improvement to facilitate a direct comparison between the two treatments. The final single, combined value will be reported as CO2 emissions in tonnes.	After treatment is concluded (Time 1) and 3-months follow-up (Time 2)
Between-groups and within-subjects mean change in Side Effects	Participants will be asked to rate the frequency of possible side effects. The prompt instruction is: How often have you been bothered by these problems in the last 2 weeks? Nausea; Headache; Tremor/ shaking hands; Heart palpitations; Constipation; Dizziness; Indigestion; Pain; Insomnia; Fatigue. Scoring options include: 0=not at all, 1=several days, 2=more than half of the days, 3=nearly every day. Lower values suggest lower rates of side effects.	Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Between-groups Comparative Cost-Effectiveness (Exploratory)	To conduct a cost-effectiveness analysis, we will delineate all direct and indirect costs associated with interventions, including treatment session fees, medication costs, healthcare professional time, and travel expenses for patients. Incremental cost-effectiveness ratios (ICERs) will be calculated by comparing the difference in mean costs to the difference in mean effectiveness between the two treatments, with effectiveness measured in quality-adjusted life years (QALYs) gained, derived from validated, condition-specific health-related quality of life measures. A decision-analytic model will be employed to extrapolate trial results to a longer time horizon, and sensitivity analyses involving varying key parameters will be used to assess the robustness of the results and account for uncertainty in the trial data and model projections.	After treatment is concluded (Time 1) and at 3-months follow-up (Time 2)
Alcohol Use Rate (Exploratory)	Alcohol use rate will be evaluated with the Alcohol Use Disorders Identification Test (AUDIT-C). One question: How often do you have a drink containing alcohol? From Never (0), Monthly or less (1), 2-4 month (2), 2-3 times per week (3) to 4+ times per week (4).	Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3).
Smoking Rate (Exploratory)	Smoking rate will be measured with the Cigarette Dependence Scale short version (CDS). The CDS scale will ask e.g., On average, how many cigarettes do you smoke per day? From zero (0) I don't smoke to 30+ (5).	Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3).
Between-groups and within-subjects mean change in Social Media Addiction (Exploratory)	The Smartphone Application-Based Addiction Scale (SABAS) (21) will be used to evaluate mean changes in phone use behavior. This scale comprises six items (e.g., "My smartphone is the most important thing in my life"). The six items are responded to using a five-point Likert type scale ranging between 1 (very rarely) and 5 (very often).	Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3).
Between-groups and within-subjects mean change in physical exercise (Exploratory)	International Physical Activity Questionnaire (IPAQ) (22): In the past 7 days, how many days have you engaged in the following physical activities, each lasting at least 20-30 minutes? Light activity: the heart rate is only slightly faster than usual, such as walking to the supermarket or doing housework; Moderate-intensity activity: heart rate noticeably faster than usual, such as brisk walking, jogging, or light cycling. High-intensity activities: The heart rate noticeably speeds up significantly, such as playing badminton, aerobic exercise, or heavy weight training. (0 days - 5 days or more)	Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3).
Between-groups and within-subjects mean change in positive emotional states (Exploratory)	Adapted PANAS scale and single-item happiness/ life satisfaction question will be asked (23). Participants are asked how often you feel these emotions: Happiness, Calm, Joy, Love, Contentment, Enthusiasm, and Hope (1=never to 5=always). Overall, how happy are you with your life? 1=very unhappy to 7=very happy.	Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3).
Between-groups and within-subjects mean change in emotional regulation (Exploratory)	Emotional Regulation Inventory (24): To what extent do you agree with these statements: e.g., "When I experience negative emotions, I feel I have little control over my behavior" (from 1=not at all to 5=All the time)	Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3).

Collaborators and Investigators

• Sponsor: Duke Kunshan University
• Collaborators: National Natural Science Foundation of China; Kunshan Hospital of Traditional Chinese Medicine; Kunshan Mental Health Center
• Investigators: Principal Investigator: Claudia Nisa, Duke Kunshan University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: March 30, 2026
• First Submitted That Met QC Criteria: April 20, 2026
• First Posted (Actual): April 27, 2026

Study Record Updates

• Last Update Posted (Actual): July 29, 2026
• Last Update Submitted That Met QC Criteria: July 28, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Depression; sleep; Acupuncture; anxiety; Antidepressants
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Behavior; Anxiety Disorders; Depression; Therapeutics; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Complementary Therapies; Central Nervous System Agents; Psychotropic Drugs; Acupuncture Therapy
• Other Study ID Numbers: 2025CN019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Guidelines from the Chinese Government prevent sharing Chinese nationals individual participant data (IPD) with foreigners

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No