NCT06638450 Clinical Trial for Acupuncture in Adolescents With Psychological Distress and Insomnia
| NCT ID | NCT06638450 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Hong Kong |
| Condition | Psychological Distress |
| Study Type | INTERVENTIONAL |
| Enrollment | 148 participants |
| Start Date | 2026-08-18 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 148 participants in total. It began in 2026-08-18 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: Participants will be eligible for this study if they: 1. 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); 2. have symptoms that have persistent for more than 3 months; 3. are able to provide informed consent for participation, and complete treatments and questionnaires as scheduled; and 4. 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). Exclusion Criteria: Participants will be excluded if they: 1. 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; 2. have bipolar or psychotic disorder (e.g. schizophrenia); 3. have a history of brain injury or surgery; 4. have alcohol abuse or substance abuse; 5. are pregnant or in lactation, or intend to conceive; 6. have heart pacemaker or other metal devices implanted in the body; 7. have concurrent or use of drug treatment for anxiety/depression in the previous 6 months; 8. have treatment with acupuncture or brain stimulation in the previous 6 months; 9. have a history of epilepsy; 10. have a condition of bleeding tendency, or coagulopathy, or currently receiving anti-coagulant treatment; or 11. involved in other interventional clinical studies in the last 3 months or any relevant condition potentially interfering with study evaluation.
Contact & Investigator
Zhang-Jin Zhang, MMed, PhD
PRINCIPAL INVESTIGATOR
The University of Hong Kong
Frequently Asked Questions
Who can join the NCT06638450 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, up to 22 Years, studying Psychological Distress. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06638450 currently recruiting?
Yes, NCT06638450 is actively recruiting participants. Contact the research team at zhangzj@hku.hk for enrollment information.
Where is the NCT06638450 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT06638450 clinical trial?
NCT06638450 is sponsored by The University of Hong Kong. The principal investigator is Zhang-Jin Zhang, MMed, PhD at The University of Hong Kong. The trial plans to enroll 148 participants.