BackgroundSince the emergence of the COVID-19 pandemic, there have been lots of published work examining the association between COVID-19 and mental health, particularly, anxiety and depression in the general populations and disease subpopulations globally. Depression is a debilitating disorder affecting individuals' level of bio-psychological-social functioning across different age groups. Since almost all studies were cross-sectional studies, there seems to be a lack of robust, large-scale, and technological-based interventional studies to restore the general public's optimal psychosocial wellbeing amidst the COVID-19 pandemic. Transcranial pulse stimulation (TPS) is a relatively new non-intrusive brain stimulation (NIBS) technology, and only a paucity of studies was conducted related to the TPS treatment on older adults with mild neurocognitive disorders. However, there is by far no study conducted on young adults with major depressive disorder nationwide. This gives us the impetus to execute the first nationwide study evaluating the efficacy of TPS on the treatment of depression among young adults in Hong Kong.MethodsThis study proposes a two-armed single-blinded randomised controlled trial including TPS as an intervention group and a waitlist control group. Both groups will be measured at baseline (T1), immediately after the intervention (T2), and at the 3- month follow-up (T3).RecruitmentA total of 30 community-dwelling subjects who are aged 18 and above and diagnosed with major depressive disorder (MDD) will be recruited in this study. All subjects will be computer randomised into either the intervention group or the waitlist control group, balanced by gender and age on a 1:1 ratio.InterventionAll subjects in each group will have to undertake functional MRI (fMRI) before and after six 30-min TPS sessions, which will be completed in 2 weeks' time.OutcomesBaseline measurements and post-TPS evaluation of the psychological outcomes (i.e., depression, cognition, anhedonia, and instrumental activities of daily living) will also be conducted on all participants. A 3-month follow-up period will be usedto assess the long-term sustainability of the TPS intervention. For statistical analysis, ANOVA with repeated measures will be used to analyse data. Missing data were managed by multiple mutations. The level of significance will be set to p < 0.05.Significance of the StudyResults of this study will be used to inform health policy to determine whether TPS could be considered as a top treatment option for MDD.Clinical Trial RegistrationClinicalTrials.gov, identifier: NCT05006365.

Introduction Acupuncture is an alternative treatment for improving sleep quality and the effectiveness is thought to be optimized with an individualized approach resembling real practice. However, existing evidence is limited by methodological shortcomings due to blinding issues, standardized measures, and diagnostic procedures. It was of the present study’s interest to examine the efficacy and safety of semi-individualized acupuncture treatment on insomnia. Methods Adults with DSM-5 insomnia disorder (n = 140) were randomized with 1:1 allocation to a 4-week intervention traditional acupuncture (TA) or validated non-invasive sham acupuncture (SA). The selection of acupoints was semi-individualized by the acupuncturist. As the primary outcome, the sleep efficiency (SE) by sleep diary was assessed at baseline, 1-week posttreatment, and 5-week posttreatment. Other sleep parameters derived from sleep diary, the wrist-actigraphy-derived sleep parameters, insomnia symptom severity, anxiety, and depressive symptoms, as well as the health-related quality of life, were also evaluated. Results Although linear mixed-effect model revealed both groups did not attain significant difference in sleep-diary-derived SE and other outcome measures (all P > 0.05), TA promising effect on improving insomnia symptom (within-group effect size, d = 1.13 & 1.30 at 1-week & 5-week posttreatment respectively) and also a higher proportion of subjects achieved SE ≥ 85% compared with SA (55.6% versus 36.4% at week 9, P = 0.03). Besides, subjects in TA group reported significantly greater improvement in both the total sleep time (TST) derived from sleep diary and actigraph than those in the SA group at 1-week posttreatment (difference in mean changes from baseline: sleep diary = 22.0 min, p = 0.01; actigraphy =18.8 min, P = 0.02) but not 5-week posttreatment. Conclusion This study is the first to evaluate the effect of the TCM-theory-based individualized acupuncture on sleep using a sham-control design. A 4-week semi-individualized acupuncture is able to significantly increase total sleep time with few adverse events. Support (if any) Research Grants Council of Hong Kong, Early Career Scheme (Project no.: 25101017)