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Clinical Trial for Acupuncture in Adolescents With Psychological Distress and Insomnia

RecruitingNA

Sponsor: The University of Hong Kong

Conditions: Psychological Distress, Insomnia

Interventions: Dense Cranial Electroacupuncture Stimulation plus Body Acupuncture (DCEAS+BA), Minimal Acupuncture Stimulation (MAS)

Countries: Hong Kong

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.

Eligibility overview

Sex: ALL

Age: 15 Years to 22 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Hong Kong, Hong Kong, Hong Kong