Psychological DistressNCT06638450
Clinical Trial for Acupuncture in Adolescents With Psychological Distress and Insomnia
A study testing Dense Cranial Electroacupuncture Stimulation plus Body Acupuncture (DCEAS+BA) and Minimal Acupuncture Stimulation (MAS) in people with Psychological Distress and Insomnia, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 22 years
- Conditions the study is for
- Psychological Distress, Insomnia
- What is being tested?
- Dense Cranial Electroacupuncture Stimulation plus Body Acupuncture (DCEAS+BA) and Minimal Acupuncture Stimulation (MAS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 1 siteHong Kong
- Study dates
- 18 Aug 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participants 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).
Who cannot join
- Participants 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;
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
School of Chinese Medicine University of Hong Kong
Hong Kong, Hong Kong, 000000
Stella Chan Postdoctoral Fellow, (852) 39176471, chstella@hku.hk
About this study
Official title: Dense Cranial Electroacupuncture Stimulation Plus Body Acupuncture for Adolescents With Psychological Distress: a Randomized Controlled Trial With Observations on Salivary Oxytocin and Cortisol Changes
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.
Read the detailed description
Psychological distress refers to a state of emotional suffering characterized by symptom(s) including anxiety, depression, and stress, and is often accompanied by somatic symptoms such as insomnia, headache, and lack of energy. As subclinical symptoms or clinical diagnoses, anxiety and depression are often core symptoms in psychological distress. They are highly comorbid and are often accompanied by physical and sleep problems. Psychological distress is particularly prevalent in adolescents and can be a precursor or features of various psychiatric disorders. One epidemiological study conducted in Hong Kong local university students has revealed that approximately 70% of students complained of some degree of depression and 54% of anxiety; nearly 9% had moderately severe to severe depressive symptoms and 6% had severe anxiety. Two most recent large-scale surveys respectively conducted in Hong Kong and China further revealed about 17% of children and youths probably had a mental problem. This has become more severe during and post COVID-19 pandemic. However, psychiatric disorders of youths are often underdiagnosed and vastly undertreated, because the condition of most young patients is mild and they may fear drugs' side effects which sometimes are a greater risk than the disease itself. This has led to particularly low acceptability for medication interventions in adolescents. The development of novel non-pharmacological treatment strategies for youth is therefore greatly desired.
A large body of evidence well confirms the benefits and effectiveness of acupuncture in the treatment of depression, anxiety, and various related disorders. Recently, we further developed a novel acupuncture mode called 'dense cranial electroacupuncture stimulation plus body acupuncture (DCEAS+BA)', where "dense" represents the use of many acupoints mainly located on the forehead. DCEAS is a novel nerve stimulation that is established based on neuroanatomical rationales, i.e., electrical stimulation is conducted on many forehead acupoints that are innervated by the first branch of the trigeminal nerve. We have demonstrated the effectiveness of DCEAS in the treatment of major depression, post-stroke cognitive impairment, insomnia, obsessive-compulsive disorder (OCD), and chemotherapy-induced cognitive impairment. Previous studies also have revealed that transcutaneous trigeminal nerve stimulation is effective in reducing depression, anxiety, attention-deficit/hyperactivity disorder (ADHD) and epilepsy. Compared to adults, adolescents are more sensitive to peripheral nerve stimulation, producing robust neuromodulatory effects. These have led to the hypothesis that DCEAS+BA may have particular effects in alleviating adolescents' psychological distress.
Saliva collection is highly acceptable for children and adolescents. Salivary oxytocin and cortisol are the two most compelling biomarkers for screenings, diagnoses, and predicting treatment outcomes in children and adolescents with psychiatric disorders. Children and adolescents with social disorder and emotional distress had significantly lower levels of salivary oxytocin and higher cortisol levels. Electroacupuncture and acupuncture suppressed salivary cortisol levels while anxiety symptoms were alleviated. The oxytocin system plays an important role in the therapeutic mechanisms of acupuncture in the treatment of pain disorders and autism. These studies suggest that salivary oxytocin and cortisol could serve as valid biomarkers for predicting the treatment outcomes of acupuncture.
Over the past years, we have completed a series of clinical trials evaluating the efficacy of acupuncture, with particular DCEAS+BA in patients with cognitive impairment, depression, and insomnia. However, our previous studies of DCEAS mainly focused on the general population with psychiatric disorders and aged subjects with stroke, and only estimated clinical efficacy, but did not explore associations with specific biomarker profiles. In particular, it is not yet validated in young subjects with psychological distress.
There have been several lines of evidence suggesting that younger subjects with psychiatric disorders could achieve earlier responses and may be more efficacious for nerve and brain stimulation compared to older adults. There also exists an age difference in the analgesic effects of electroacupuncture between adult and juvenile rats. On the other hand, meta-analysis and recent trials suggested that acupuncture and electroacupuncture may have more benefits in treating anxiety disorders and insomnia, and produce comparable efficacy in improving anxiety disorders as compared to anxiolytics. This has led to the anticipation that youths with psychological distress could achieve better outcomes on DCEAS+BA compared to other subpopulations. Therefore, we further propose this trial to examine the efficacy of DCEAS+BA and its associations with salivary oxytocin and cortisol in adolescents with psychological distress. As youths with psychiatric disorders are vastly undertreated, are often reluctant and even decline to take the medications due to fear of the drugs' side effects, the validation of the efficacy of DCEAS+BA provides an effective and acceptable option for this special subpopulation. The exploration of the associations with biomarkers will help us gain more insights into the mechanisms of DCEAS.
- Conditions
- Psychological Distress, Insomnia
- Being tested
- Dense Cranial Electroacupuncture Stimulation plus Body Acupuncture (DCEAS+BA), Minimal Acupuncture Stimulation (MAS)
- Keywords
- Psychological distress, Insomnia, Acupuncture, Adolescent
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dense Cranial Electroacupuncture Stimulation plus Body Acupuncture (DCEAS+BA)Procedure or surgery
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 or surgery
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 group | Role | What they receive |
|---|---|---|
| DCEAS+BA group | Experimental | 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. Receives: Procedure: Dense Cranial Electroacupuncture Stimulation plus Body Acupuncture (DCEAS+BA) |
| MAS group | Sham comparator | 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. Receives: Procedure: Minimal Acupuncture Stimulation (MAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, Week 4, Week 8, Week 12
Secondary outcomes (7)
Change in the Beck Depression Inventory-II score
Beck Depression Inventory-II (C-BDI-II) is used to measure the severity of depression 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).
Measured: Baseline, Week 4, Week 8, Week 12
Change in the Zung Self-Rating Anxiety Scale score
Zung Self-Rating Anxiety Scale (SAS) is used to measure the severity of anxiety and its overall score ranges from 25 to 100. A higher score indicates greater severity. Assessments will be conducted at baseline, week 4, week 8 and week 12 (post-intervention visit).
Measured: Baseline, Week 4, Week 8, Week 12
Change in the Zung Self-Rating Depression Scale score
Zung Self-Rating Depression Scale (SDS) is used to measure the severity of depression and its overall score ranges from 25 to 100. A higher score indicates greater severity. Assessments will be conducted at baseline, week 4, week 8 and week 12 (post-intervention visit).
Measured: Baseline, Week 4, Week 8, Week 12
Change in the Pittsburgh Sleep Quality Index score
Pittsburgh Sleep Quality Index (PSQI) is used to assess sleep quality and its overall score ranges from 0 to 21. A higher score indicates more acute sleep disturbances. Assessments will be conducted at baseline, week 4, week 8 and week 12 (post-intervention visit).
Measured: Baseline, Week 4, Week 8, Week 12
Change in the World Health Organization Quality of Life-Brief (HK version) score
World Health Organization Quality of Life-Brief (WHOQOL-BREF) (HK version) is used to assess quality of life, with four quality of life domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items). Each individual item is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed linearly to a 0-100-scale. A higher score indicates better quality of life. Assessments will be conducted at baseline, week 4, week 8 and week 12 (post-intervention visit).
Measured: Baseline, Week 4, Week 8, Week 12
Salivary oxytocin level
Salivary samples will be collected at baseline and 8-week respectively. On collection day, 2 salivary samples will be collected in 08:00-09:00 and 20:00-21:00, respectively, to meet the cortisol circadian rhythm with peak time at 08:30 and the lowest level at 20:00-22:00. Volume of each sample collected is 3-4 ml and the detailed procedure is described in assay kit. Oxytocin and cortisol concentrations will be analyzed using enzyme-linked immunosorbent assay (ELISA) kits.
Measured: Baseline and Week 8
Salivary cortisol level
Salivary samples will be collected at baseline and 8-week respectively. On collection day, 2 salivary samples will be collected in 08:00-09:00 and 20:00-21:00, respectively, to meet the cortisol circadian rhythm with peak time at 08:30 and the lowest level at 20:00-22:00. Volume of each sample collected is 3-4 ml and the detailed procedure is described in assay kit. Oxytocin and cortisol concentrations will be analyzed using enzyme-linked immunosorbent assay (ELISA) kits.
Measured: Baseline and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start18 Aug 2026
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Tung Wah Group of Hospitals
- Responsible party
- Principal investigator, Prof. Zhang Zhang-Jin, The University of Hong Kong
- Investigators
- Zhang-Jin Zhang, MMed, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06638450
- Sponsor's protocol ID
- UW 24-333
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2024
- Last updated
- 3 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen CJ, Chen YC, Ho CS, Lee YC. Effects of preferred music therapy on peer attachment, depression, and salivary cortisol among early adolescents in Taiwan. J Adv Nurs. 2019 Sep;75(9):1911-1921. doi: 10.1111/jan.13975. Epub 2019 Mar 13.
PubMed 30746740Li M, Liu X, Ye X, Zhuang L. Efficacy of acupuncture for generalized anxiety disorder: A PRISMA-compliant systematic review and meta-analysis. Medicine (Baltimore). 2022 Dec 9;101(49):e30076. doi: 10.1097/MD.0000000000030076.
PubMed 36626458Cook IA, Abrams M, Leuchter AF. Trigeminal Nerve Stimulation for Comorbid Posttraumatic Stress Disorder and Major Depressive Disorder. Neuromodulation. 2016 Apr;19(3):299-305. doi: 10.1111/ner.12399. Epub 2016 Jan 28.
PubMed 26818103Cotovio G, Boes AD, Press DZ, Oliveira-Maia AJ, Pascual-Leone A. In Older Adults the Antidepressant Effect of Repetitive Transcranial Magnetic Stimulation Is Similar but Occurs Later Than in Younger Adults. Front Aging Neurosci. 2022 Jul 19;14:919734. doi: 10.3389/fnagi.2022.919734. eCollection 2022.
PubMed 35928992DeGiorgio CM, Soss J, Cook IA, Markovic D, Gornbein J, Murray D, Oviedo S, Gordon S, Corralle-Leyva G, Kealey CP, Heck CN. Randomized controlled trial of trigeminal nerve stimulation for drug-resistant epilepsy. Neurology. 2013 Feb 26;80(9):786-91. doi: 10.1212/WNL.0b013e318285c11a. Epub 2013 Jan 30.
PubMed 23365066Enck P, Klosterhalfen S, Zipfel S. Acupuncture, psyche and the placebo response. Auton Neurosci. 2010 Oct 28;157(1-2):68-73. doi: 10.1016/j.autneu.2010.03.005. Epub 2010 Apr 1.
PubMed 20359961Gordon I, Zagoory-Sharon O, Schneiderman I, Leckman JF, Weller A, Feldman R. Oxytocin and cortisol in romantically unattached young adults: associations with bonding and psychological distress. Psychophysiology. 2008 May;45(3):349-52. doi: 10.1111/j.1469-8986.2008.00649.x. Epub 2008 Feb 4.
PubMed 18266803Han JS. Acupuncture: neuropeptide release produced by electrical stimulation of different frequencies. Trends Neurosci. 2003 Jan;26(1):17-22. doi: 10.1016/s0166-2236(02)00006-1. No abstract available.
PubMed 12495858Ho CY, Lee A. Cultivating a Healthy Living Environment for Adolescents in the Post-COVID Era in Hong Kong: Exploring Youth Health Needs. Int J Environ Res Public Health. 2022 Jun 9;19(12):7072. doi: 10.3390/ijerph19127072.
PubMed 35742326Huang W, Taylor A, Howie J, Robinson N. Is the diurnal profile of salivary cortisol concentration a useful marker for measuring reported stress in acupuncture research? A randomized controlled pilot study. J Altern Complement Med. 2012 Mar;18(3):242-50. doi: 10.1089/acm.2010.0325. Epub 2012 Mar 2.
PubMed 22385023Kohlhoff J, Cibralic S, Hawes DJ, Eapen V. Oxytocin receptor gene (OXTR) polymorphisms and social, emotional and behavioral functioning in children and adolescents: A systematic narrative review. Neurosci Biobehav Rev. 2022 Apr;135:104573. doi: 10.1016/j.neubiorev.2022.104573. Epub 2022 Feb 9.
PubMed 35149102Lebowitz ER, Leckman JF, Feldman R, Zagoory-Sharon O, McDonald N, Silverman WK. Salivary oxytocin in clinically anxious youth: Associations with separation anxiety and family accommodation. Psychoneuroendocrinology. 2016 Mar;65:35-43. doi: 10.1016/j.psyneuen.2015.12.007. Epub 2015 Dec 14.
PubMed 26716876Li F, Cui Y, Li Y, Guo L, Ke X, Liu J, Luo X, Zheng Y, Leckman JF. Prevalence of mental disorders in school children and adolescents in China: diagnostic data from detailed clinical assessments of 17,524 individuals. J Child Psychol Psychiatry. 2022 Jan;63(1):34-46. doi: 10.1111/jcpp.13445. Epub 2021 May 21.
PubMed 34019305Li L, Lok GKI, Mei SL, Cui XL, An FR, Li L, Cheung T, Ungvari GS, Xiang YT. Prevalence of depression and its relationship with quality of life among university students in Macau, Hong Kong and mainland China. Sci Rep. 2020 Sep 25;10(1):15798. doi: 10.1038/s41598-020-72458-w.
PubMed 32978428Notkins AL, Prabhakar BS. Monoclonal autoantibodies that react with multiple organs. Basis for reactivity. Ann N Y Acad Sci. 1986;475:123-34. doi: 10.1111/j.1749-6632.1986.tb20862.x.
PubMed 3024548
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dense Cranial Electroacupuncture Stimulation Plus Body Acupuncture for Adolescents With Psychological Distress: a Randomized Controlled Trial With Observations on Salivary Oxytocin and Cortisol Changes
- ClinicalTrials.gov ID
- NCT06638450
- Acronym / sponsor ID
- UW 24-333
- Conditions
- Psychological Distress, Insomnia
- Keywords
- Psychological distress, Insomnia, Acupuncture, Adolescent
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Tung Wah Group of Hospitals
- Study start
- 18 Aug 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Psychological distress refers to a state of emotional suffering characterized by symptom(s) including anxiety, depression, and stress, and is often accompanied by somatic symptoms such as insomnia, headache, and lack of energy. As subclinical symptoms or clinical diagnoses, anxiety and depression are often core symptoms in psychological distress. They are highly comorbid and are often accompanied by physical and sleep problems. Psychological distress is particularly prevalent in adolescents and can be a precursor or features of various psychiatric disorders. One epidemiological study conducted in Hong Kong local university students has revealed that approximately 70% of students complained of some degree of depression and 54% of anxiety; nearly 9% had moderately severe to severe depressive symptoms and 6% had severe anxiety. Two most recent large-scale surveys respectively conducted in Hong Kong and China further revealed about 17% of children and youths probably had a mental problem. This has become more severe during and post COVID-19 pandemic. However, psychiatric disorders of youths are often underdiagnosed and vastly undertreated, because the condition of most young patients is mild and they may fear drugs' side effects which sometimes are a greater risk than the disease itself. This has led to particularly low acceptability for medication interventions in adolescents. The development of novel non-pharmacological treatment strategies for youth is therefore greatly desired.
A large body of evidence well confirms the benefits and effectiveness of acupuncture in the treatment of depression, anxiety, and various related disorders. Recently, we further developed a novel acupuncture mode called 'dense cranial electroacupuncture stimulation plus body acupuncture (DCEAS+BA)', where "dense" represents the use of many acupoints mainly located on the forehead. DCEAS is a novel nerve stimulation that is established based on neuroanatomical rationales, i.e., electrical stimulation is conducted on many forehead acupoints that are innervated by the first branch of the trigeminal nerve. We have demonstrated the effectiveness of DCEAS in the treatment of major depression, post-stroke cognitive impairment, insomnia, obsessive-compulsive disorder (OCD), and chemotherapy-induced cognitive impairment. Previous studies also have revealed that transcutaneous trigeminal nerve stimulation is effective in reducing depression, anxiety, attention-deficit/hyperactivity disorder (ADHD) and epilepsy. Compared to adults, adolescents are more sensitive to peripheral nerve stimulation, producing robust neuromodulatory effects. These have led to the hypothesis that DCEAS+BA may have particular effects in alleviating adolescents' psychological distress.
Saliva collection is highly acceptable for children and adolescents. Salivary oxytocin and cortisol are the two most compelling biomarkers for screenings, diagnoses, and predicting treatment outcomes in children and adolescents with psychiatric disorders. Children and adolescents with social disorder and emotional distress had significantly lower levels of salivary oxytocin and higher cortisol levels. Electroacupuncture and acupuncture suppressed salivary cortisol levels while anxiety symptoms were alleviated. The oxytocin system plays an important role in the therapeutic mechanisms of acupuncture in the treatment of pain disorders and autism. These studies suggest that salivary oxytocin and cortisol could serve as valid biomarkers for predicting the treatment outcomes of acupuncture.
Over the past years, we have completed a series of clinical trials evaluating the efficacy of acupuncture, with particular DCEAS+BA in patients with cognitive impairment, depression, and insomnia. However, our previous studies of DCEAS mainly focused on the general population with psychiatric disorders and aged subjects with stroke, and only estimated clinical efficacy, but did not explore associations with specific biomarker profiles. In particular, it is not yet validated in young subjects with psychological distress.
There have been several lines of evidence suggesting that younger subjects with psychiatric disorders could achieve earlier responses and may be more efficacious for nerve and brain stimulation compared to older adults. There also exists an age difference in the analgesic effects of electroacupuncture between adult and juvenile rats. On the other hand, meta-analysis and recent trials suggested that acupuncture and electroacupuncture may have more benefits in treating anxiety disorders and insomnia, and produce comparable efficacy in improving anxiety disorders as compared to anxiolytics. This has led to the anticipation that youths with psychological distress could achieve better outcomes on DCEAS+BA compared to other subpopulations. Therefore, we further propose this trial to examine the efficacy of DCEAS+BA and its associations with salivary oxytocin and cortisol in adolescents with psychological distress. As youths with psychiatric disorders are vastly undertreated, are often reluctant and even decline to take the medications due to fear of the drugs' side effects, the validation of the efficacy of DCEAS+BA provides an effective and acceptable option for this special subpopulation. The exploration of the associations with biomarkers will help us gain more insights into the mechanisms of DCEAS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DCEAS+BA group | Experimental | Procedure: Dense Cranial Electroacupuncture Stimulation plus Body Acupuncture (DCEAS+BA)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. |
| MAS group | Sham comparator | Procedure: Minimal Acupuncture Stimulation (MAS)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. |
Who may qualify
- Ages
- 15 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dense Cranial Electroacupuncture Stimulation plus Body Acupuncture (DCEAS+BA)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. | Procedure or surgery | DCEAS+BA group |
| Minimal Acupuncture Stimulation (MAS)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. | Procedure or surgery | MAS group |
Primary outcome
Change in the Beck Anxiety Inventory score
Time frame: Baseline, Week 4, Week 8, Week 12
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).
7 secondary outcomes
Change in the Beck Depression Inventory-II score
Time frame: Baseline, Week 4, Week 8, Week 12
Change in the Zung Self-Rating Anxiety Scale score
Time frame: Baseline, Week 4, Week 8, Week 12
Change in the Zung Self-Rating Depression Scale score
Time frame: Baseline, Week 4, Week 8, Week 12
Change in the Pittsburgh Sleep Quality Index score
Time frame: Baseline, Week 4, Week 8, Week 12
Change in the World Health Organization Quality of Life-Brief (HK version) score
Time frame: Baseline, Week 4, Week 8, Week 12
Salivary oxytocin level
Time frame: Baseline and Week 8
Salivary cortisol level
Time frame: Baseline and Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Background: PubMed 30746740Chen CJ, Chen YC, Ho CS, Lee YC. Effects of preferred music therapy on peer attachment, depression, and salivary cortisol among early adolescents in Taiwan. J Adv Nurs. 2019 Sep;75(9):1911-1921. doi: 10.1111/jan.13975. Epub 2019 Mar 13.
- Background: PubMed 36626458Li M, Liu X, Ye X, Zhuang L. Efficacy of acupuncture for generalized anxiety disorder: A PRISMA-compliant systematic review and meta-analysis. Medicine (Baltimore). 2022 Dec 9;101(49):e30076. doi: 10.1097/MD.0000000000030076.
- Background: PubMed 26818103Cook IA, Abrams M, Leuchter AF. Trigeminal Nerve Stimulation for Comorbid Posttraumatic Stress Disorder and Major Depressive Disorder. Neuromodulation. 2016 Apr;19(3):299-305. doi: 10.1111/ner.12399. Epub 2016 Jan 28.
- Background: PubMed 35928992Cotovio G, Boes AD, Press DZ, Oliveira-Maia AJ, Pascual-Leone A. In Older Adults the Antidepressant Effect of Repetitive Transcranial Magnetic Stimulation Is Similar but Occurs Later Than in Younger Adults. Front Aging Neurosci. 2022 Jul 19;14:919734. doi: 10.3389/fnagi.2022.919734. eCollection 2022.
- Background: PubMed 23365066DeGiorgio CM, Soss J, Cook IA, Markovic D, Gornbein J, Murray D, Oviedo S, Gordon S, Corralle-Leyva G, Kealey CP, Heck CN. Randomized controlled trial of trigeminal nerve stimulation for drug-resistant epilepsy. Neurology. 2013 Feb 26;80(9):786-91. doi: 10.1212/WNL.0b013e318285c11a. Epub 2013 Jan 30.
- Background: PubMed 20359961Enck P, Klosterhalfen S, Zipfel S. Acupuncture, psyche and the placebo response. Auton Neurosci. 2010 Oct 28;157(1-2):68-73. doi: 10.1016/j.autneu.2010.03.005. Epub 2010 Apr 1.
- Background: PubMed 18266803Gordon I, Zagoory-Sharon O, Schneiderman I, Leckman JF, Weller A, Feldman R. Oxytocin and cortisol in romantically unattached young adults: associations with bonding and psychological distress. Psychophysiology. 2008 May;45(3):349-52. doi: 10.1111/j.1469-8986.2008.00649.x. Epub 2008 Feb 4.
- Background: PubMed 12495858Han JS. Acupuncture: neuropeptide release produced by electrical stimulation of different frequencies. Trends Neurosci. 2003 Jan;26(1):17-22. doi: 10.1016/s0166-2236(02)00006-1. No abstract available.
- Background: PubMed 35742326Ho CY, Lee A. Cultivating a Healthy Living Environment for Adolescents in the Post-COVID Era in Hong Kong: Exploring Youth Health Needs. Int J Environ Res Public Health. 2022 Jun 9;19(12):7072. doi: 10.3390/ijerph19127072.
- Background: PubMed 22385023Huang W, Taylor A, Howie J, Robinson N. Is the diurnal profile of salivary cortisol concentration a useful marker for measuring reported stress in acupuncture research? A randomized controlled pilot study. J Altern Complement Med. 2012 Mar;18(3):242-50. doi: 10.1089/acm.2010.0325. Epub 2012 Mar 2.
- Background: PubMed 35149102Kohlhoff J, Cibralic S, Hawes DJ, Eapen V. Oxytocin receptor gene (OXTR) polymorphisms and social, emotional and behavioral functioning in children and adolescents: A systematic narrative review. Neurosci Biobehav Rev. 2022 Apr;135:104573. doi: 10.1016/j.neubiorev.2022.104573. Epub 2022 Feb 9.
- Background: PubMed 26716876Lebowitz ER, Leckman JF, Feldman R, Zagoory-Sharon O, McDonald N, Silverman WK. Salivary oxytocin in clinically anxious youth: Associations with separation anxiety and family accommodation. Psychoneuroendocrinology. 2016 Mar;65:35-43. doi: 10.1016/j.psyneuen.2015.12.007. Epub 2015 Dec 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhang-Jin Zhang, MMed, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dense Cranial Electroacupuncture Stimulation plus Body Acupuncture (DCEAS+BA) and Minimal Acupuncture Stimulation (MAS) in people with Psychological Distress and Insomnia, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhang-Jin Zhang, MMed, PhD (+852 3917 6445, zhangzj@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Beck Anxiety Inventory score (time frame: Baseline, Week 4, Week 8, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06638450, which also lists 31 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.