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

NCT07552246 | Recruiting Phase 4 DMC

• 1 other identifier: 2025CN019
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety Depression; Sleep

Keywords

Depression; Acupuncture; Antidepressants; anxiety; sleep

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Between-groups Comparative Environmental Footprint

  After treatment is concluded (Time 1) and 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).

Other Outcomes (7)

• Between-groups Comparative Cost-Effectiveness (Exploratory)

  After treatment is concluded (Time 1) and at 3-months follow-up (Time 2)

• Alcohol Use Rate (Exploratory)

  Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3).

• Smoking Rate (Exploratory)

  Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3).

Study Arms (2)

Psychotropic Drugs

ACTIVE COMPARATOR

1. Trazodone (25-150 mg; once daily, 30 minutes before bedtime) or mirtazapine (3.75-30 mg; once daily, 30 minutes before bedtime) 2. 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

Acupuncture

EXPERIMENTAL

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

Interventions

Acupuncture OTHER

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: 1. Patient Position: Supine position. 2. Needles: Single-use sterile needles (Specifications: 0.25 mm × 40 mm; Brand: Wuxi Jiajian). 3. Disinfection: Strict disinfection protocols must be performed prior to needling. 4. Needling Technique: After insertion, lifting-thrusting and twirling-rotating manipulation techniques are applied to elicit De Qi (the arrival of Qi). 5. Needle Retention Time: 20 minutes. 6. Treatment Regimen: * Frequency: 3 sessions per week (Monday, Wednesday, and Friday). * Course of Treatment: 9 to 10 sessions per course.

Acupuncture

Psychotropic Drugs DRUG

1. Trazodone (25-150 mg; once daily, 30 minutes before bedtime) or mirtazapine (3.75-30 mg; once daily, 30 minutes before bedtime) 2. 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

Psychotropic Drugs

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke Kunshan University: lead
• Kunshan Hospital of Traditional Chinese Medicine: collaborator
• Kunshan Mental Health Center: collaborator
• National Natural Science Foundation of China: collaborator

Study Sites (1)

Kunshan Mental Health Center and Kunshan Hospital of Traditional Chinese Medicine

Kunshan, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Psychotropic Drugs; Acupuncture Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Complementary Therapies; Therapeutics

Study Officials

• Claudia Nisa

  Duke Kunshan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudia F. Nisa

CONTACT

008618151144079; claudia.nisa@duke.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Behavioral Science

Model Details: It was observed in preliminary stages of the trial that patients have very strong preferences for either acupuncture or medication. Many patients refused to be randomly assigned to treatment. Thus, the trial was changed to a preference-based trial, which allows for some patients to choose which treatment they prefer (N=60 per group in a total of 120 non-randomized patients), and for patients without a strong preference, these are randomly allocated to different treatments (N=30 per group in a total of 60 randomized patients).

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 27, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)