RecruitingNot ApplicableNCT06638450

Clinical Trial for Acupuncture in Adolescents With Psychological Distress and Insomnia

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

Sponsor

The University of Hong Kong

Enrollment

148 participants

Start Date

Aug 18, 2026

Study Type

INTERVENTIONAL

Conditions

Insomnia Psychological Distress

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.

Eligibility

Min Age: 15 YearsMax Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Dense Cranial Electroacupuncture Stimulation plus Body Acupuncture (DCEAS+BA) and a procedure called Minimal Acupuncture Stimulation (MAS) for people with insomnia and psychological distress. The study is currently recruiting participants at 1 location. People eligible for this study include aged 15 Years to 22 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREDense 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.

PROCEDUREMinimal 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.