Clinical Trial for Acupuncture in Adolescents With Psychological Distress and Insomnia

NCT06638450 | Not Yet Recruiting

• 1 other identifier: UW 24-333
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Insomnia; Psychological Distress

Keywords

Psychological distress; Insomnia; Acupuncture; Adolescent

Outcome Measures

Primary Outcomes (1)

• Change in the Beck Anxiety Inventory score

  Beck Anxiety Inventory (BAI-C) is used to measure the severity of anxiety and its overall score ranges from 0 to 63. A higher score indicates greater severity. Assessments will be conducted at baseline, week 4, week 8 and week 12 (post-intervention visit).

  Baseline, Week 4, Week 8, Week 12

Secondary Outcomes (7)

• Change in the Beck Depression Inventory-II score

  Baseline, Week 4, Week 8, Week 12

• Change in the Zung Self-Rating Anxiety Scale score

  Baseline, Week 4, Week 8, Week 12

• Change in the Zung Self-Rating Depression Scale score

  Baseline, Week 4, Week 8, Week 12

• Change in the Pittsburgh Sleep Quality Index score

  Baseline, Week 4, Week 8, Week 12

• Change in the World Health Organization Quality of Life-Brief (HK version) score

  Baseline, Week 4, Week 8, Week 12

Study Arms (2)

DCEAS+BA group

EXPERIMENTAL

Subjects 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.

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

MAS group

SHAM COMPARATOR

Subjects 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.

Procedure: Minimal Acupuncture Stimulation (MAS)

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.

DCEAS+BA group

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.

MAS group

Eligibility Criteria

• Age: 15 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Subjects will be eligible for this study if they:
• are experiencing anxiety as evidenced by a BAI-C score of at least 8 (no symptoms = 0-7; mild = 8-15; moderate = 16-25; severe = 26-63), and/or a C-BDI-II score of at least 14 (no symptoms = 0-13, mild = 14-19; moderate = 20-28; severe = 29-63);
• have symptoms that have persistent for more than 3 months;
• are able to provide informed consent for participation, and complete treatments and questionnaires as scheduled; and
• have no suicidal ideation, as evidenced by "no" answers or a score of \<3 for all questionnaires of the Columbia-Suicide Severity Rating Scale (C-SSRS).

You may not qualify if:

• Subjects will be excluded if they:
• have unstable systemic medical conditions that may limit their participation in the study, for example, severe liver, cardiovascular, or kidney impairment; gastrointestinal or endocrine dysfunction; malignancy; autoimmune disease; acute infectious disease; or any conditions with unstable vital signs or require intensive hospitalization;
• have bipolar or psychotic disorder (e.g. schizophrenia);
• have a history of brain injury or surgery;
• have alcohol abuse or substance abuse;
• are pregnant or in lactation, or intend to conceive;
• have heart pacemaker or other metal devices implanted in the body;
• have concurrent or use of drug treatment for anxiety/depression in the previous 6 months;
• have treatment with acupuncture or brain stimulation in the previous 6 months;
• have a history of epilepsy;
• have a condition of bleeding tendency, or coagulopathy, or currently receiving anti-coagulant treatment; or
• involved in other interventional clinical studies in the last 3 months or any relevant condition potentially interfering with study evaluation.

Sponsors & Collaborators

• Tung Wah Group of Hospitals: collaborator
• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong, 000000, Hong Kong

Location

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MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Zhang-Jin Zhang, MMed, PhD

  School of Chinese Medicine, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhang-Jin Zhang, MMed, PhD

CONTACT

+852 3917 6445; zhangzj@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)