Clinical Trial for Acupuncture in Adolescents With Emotional Disorders and Insomnia

This is an assessor-blinded, randomized, minimal acupuncture stimulation (MAS)-controlled trial. A total of 148 adolescents aged 15-22 years who have mild to moderate emotional disorders will be recruited. They will be randomly assigned to 'dense cranial electroacupuncture stimulation plus body acupuncture (DCEAS+BA)' (n = 74) and MAS (n = 74) groups for 2 sessions per week for 8 weeks. The primary outcome will be assessed using the Beck Anxiety Inventory (BAI). The secondary outcomes include the Beck Depression Inventory II (BDI-II) for 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. Saliva will be collected at baseline and the end of the 8-week study. 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 inter-correlations among clinical improvement and changes in biomarker levels. Subgroup analysis will be conducted to identify specific effects of DCEAS+BA.

Emotional disorders are particularly highly prevalent in adolescents. 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. 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 fear drugs' side effects.

A large body of evidence well confirms the benefits and effectiveness of acupuncture in the treatment of various depression and anxiety disorders. We have demonstrated the effectiveness of cranial electroacupuncture stimulation plus body acupuncture in the treatment of major depression, post-stroke cognitive impairment, insomnia, obsessive-compulsive disorder, and chemotherapy-induced cognitive impairment via a series of clinical trials. These results have encouraged us to further conduct a randomized controlled trial to confirm the efficacy of electroacupuncture treatment in young subjects with anxiety and emotional disorders.

Salivary oxytocin and cortisol are the two most compelling biomarkers for screenings, diagnosis, and predicting treatment outcomes in children and adolescents with psychiatric disorders. Previous studies showed that electroacupuncture and acupuncture suppressed salivary cortisol levels while anxiety symptoms were alleviated. These studies suggest that salivary oxytocin and cortisol could serve as valid biomarkers for predicting the treatment outcomes of acupuncture.

Eligibility Criteria:
Inclusion Criteria:

* are experiencing anxiety as evidenced by a BAI score of at least 8 (no symptoms = 0-7; mild = 8-15; moderate = 16-25; severe = 26-63); 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:

* are in unstable medical conditions, for example unstable vital signs, or conditions that require intensive hospitalization, that may limit their participation in the study;
* have a history of brain injury or surgery;
* are pregnancy or in lactation;
* have an investigational drug treatment in the previous 6 months;
* have a heart pacemaker or other metal devices implanted in the body;
* have treatments with acupuncture or brain stimulation in the previous 6 months;
* have a history of epilepsy; or
* have a condition of bleeding tendency, or coagulopathy, or currently receiving anti-coagulant treatment.