Clinical Trial for Acupuncture in Adolescents With Psychological Distress and Insomnia

Sponsor
The University of Hong Kong
Study ID
NCT06638450
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
15 Years - 22 Years
Healthy Volunteers
Not accepted

Interventions

  • Dense Cranial Electroacupuncture Stimulation plus Body Acupuncture (DCEAS+BA) — PROCEDURE
    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.
  • Minimal Acupuncture Stimulation (MAS) — PROCEDURE
    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.

Study Details

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.

Key Dates

First listed
Oct 15, 2024
Start date
Jul 31, 2026
Status verified
Jul 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2028

Study Design

Enrollment
148 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: DCEAS+BA group
    Participants assigned to Dense Cranial Electroacupuncture Stimulation plus Body Acupuncture (DCEAS+BA) group will receive DCEAS+BA treatment, twice weekly for 8 weeks, in addition to their current interventions and medications as usual.
  • Sham Comparator: MAS group
    Participants assigned to Minimal Acupuncture Stimulation (MAS) group will receive MAS treatment, twice weekly for 8 weeks, in addition to their current interventions and medications as usual.

Primary Outcome Measure

Change in the Beck Anxiety Inventory score [ Time Frame: Baseline, Week 4, Week 8, Week 12 ]

Central Contacts

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