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

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

Interventions

DRUG

Psychotropic Drugs

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

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: 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.

Sponsors & Collaborators

• Kunshan Hospital of Traditional Chinese Medicine

  collaborator OTHER

• Kunshan Mental Health Center

  collaborator UNKNOWN

• National Natural Science Foundation of China

  collaborator OTHER_GOV

• Duke Kunshan University

  lead OTHER

Principal Investigators

• Claudia Nisa · Duke Kunshan University

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-01

Primary Completion

2027-06-30

Completion

2027-12-31

Countries

• China

Study Locations