Clinical Trial for Acupuncture in Adolescents With Psychological Distress and Insomnia (NCT06638450) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical Trial for Acupuncture in Adolescents With Psychological Distress and Insomnia
Hong Kong148 participantsStarted 2026-07
Plain-language 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.
Who can participate
Age range
15 Years – 22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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).
Exclusion criteria
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.