Clinical Trial for Acupuncture in Adolescents With Psychological Distress and Insomnia
NCT ID: NCT06638450
Last Updated: 2026-01-26
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
148 participants
INTERVENTIONAL
2026-03-31
2028-09-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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DCEAS+BA group
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.
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.
MAS group
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
15 Years
22 Years
ALL
No
Sponsors
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Tung Wah Group of Hospitals
OTHER
The University of Hong Kong
OTHER
Responsible Party
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Prof. Zhang Zhang-Jin
Professor
Principal Investigators
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Zhang-Jin Zhang, MMed, PhD
Role: PRINCIPAL_INVESTIGATOR
School of Chinese Medicine, The University of Hong Kong
Locations
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The University of Hong Kong
Hong Kong, Hong Kong, Hong Kong
Countries
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Central Contacts
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References
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Other Identifiers
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UW 24-333
Identifier Type: -
Identifier Source: org_study_id
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