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Comparing Acupuncture With Medication to Reduce Depression, Anxiety and Comorbid Sleep Disorders in China
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.
ClinicalTrials.gov IDNCT07552246
PhasePHASE4
Enrollment180
SponsorDuke Kunshan University
Age18 Years and older
SexALL
Conditions studied
Anxiety Depression, Sleep
About this study
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.
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.
Primary outcomes
- Between-groups and within-subjects mean change 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 (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 (Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3).)
Eligibility information
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 locations
- Kunshan Mental Health Center and Kunshan Hospital of Traditional Chinese Medicine, Kunshan, Jiangsu China
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.