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NOT YET RECRUITING
NCT06638450
NA

Clinical Trial for Acupuncture in Adolescents With Psychological Distress and Insomnia

Sponsor: The University of Hong Kong

View on ClinicalTrials.gov

Summary

This is an assessor-blinded, randomized, MAS-controlled trial. A total of 148 adolescents aged 15-22 years experiencing mild to moderate anxiety or depressive symptoms will be recruited. They will be randomly assigned to DCEAS+BA (n = 74) and MAS (n = 74) for 2 sessions per week for 8 weeks, followed by a 4-week post-treatment observation period. A post-intervention visit will be held at week 12. The primary outcome will be assessed using the Chinese version of the Beck Anxiety Inventory (BAI-C). The secondary outcomes include the Beck Depression Inventory II (C-BDI-II) for depression, the Zung Self-Rating Anxiety Scale (SAS) and the Zung Self-Rating Depression Scale (SDS) as additional assessments for anxiety and depression, the Pittsburgh Sleep Quality Index (PSQI) for sleep quality, and the World Health Organization Quality of Life-Brief (WHOQOL-BREF) (HK version) for the general quality of life. Assessment will be carried out every 4 weeks till week 12, while saliva will be collected at baseline and at the end of the 8 weeks. Salivary oxytocin and cortisol will be analyzed. A generalized linear mixed-effect model will be applied to compare treatment outcomes over time in the two groups and linear regression will be conducted to examine intercorrelations among clinical improvement and changes in biomarker levels. Subgroup analysis will be conducted to identify specific effects of DCEAS+BA.

Official title: Dense Cranial Electroacupuncture Stimulation Plus Body Acupuncture for Adolescents With Psychological Distress: a Randomized Controlled Trial With Observations on Salivary Oxytocin and Cortisol Changes

Key Details

Gender

All

Age Range

15 Years - 22 Years

Study Type

INTERVENTIONAL

Enrollment

148

Start Date

2026-03

Completion Date

2028-09

Last Updated

2026-01-26

Healthy Volunteers

No

Interventions

PROCEDURE

Dense Cranial Electroacupuncture Stimulation plus Body Acupuncture (DCEAS+BA)

DCEAS+BA will be conducted for 2 sessions per week for 8 weeks. For DCEAS, 6 pairs of acupoints are used: Baihui (GV20) and Yintang (EX-HN3), left Sishencong (EX-HN1) and Toulinqi (GB15), right Sishencong (EX-HN1) and Toulinqi (GB15), bilateral Shuaigu (GB8), bilateral Taiyang (EX-HN5), and bilateral Touwei (ST8). For body acupuncture, the following acupoints are used: Shenmen (HT7). Neiguan (PC6), Zhongwan (CV12), Guanyuan (CV4), Zusanli (ST36), Sanyinjiao (SP6), and Taichong (LV3). Disposable acupuncture needles (0.25 mm in diameter and 25-40 mm in length) are inserted at a depth of 10-30 mm perpendicularly or obliquely into acupoints. Manual manipulation is conducted to evoke a needling sensation. After that, electrical stimulation is delivered on DCEAS, with continuous waves at 2 Hz through an electrical acupuncture stimulation instrument (Hwarto, SDZ-II). The stimulation lasts 30 minutes.

PROCEDURE

Minimal Acupuncture Stimulation (MAS)

MAS will be conducted for 2 sessions per week for 8 weeks. The following 6 acupoints are used: bilateral Tongtian (BL07), bilateral Shousanli (LI10) and bilateral Fuyang (BL59). Disposable acupuncture needles (0.25 mm in diameter and 25-40 mm in length) are inserted at a depth of 10-30 mm perpendicularly or obliquely into acupoints. After that, electrical stimulation is performed on bilateral Tongtian (BL07), with continuous waves at 2 Hz through an electrical acupuncture stimulation instrument (Hwarto, SDZ-II). The stimulation lasts 30 minutes.

Locations (1)

The University of Hong Kong

Hong Kong, Hong Kong, Hong Kong