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Clinical Trial for Acupuncture in Adolescents With Psychological Distress and Insomnia

RecruitingNAAges 15 Years - 22 YearsAllThe University of Hong Kong
NCT06638450 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 qual

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📋 Eligibility rules (as published)
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.
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What it tests

  • Dense Cranial Electroacupuncture Stimulation plus Body Acupuncture (DCEAS+BA)
  • Minimal Acupuncture Stimulation (MAS)
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Where

1 site
School of Chinese Medicine University of Hong Kong
Hong Kong, Hong Kong
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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