Insomnia, depression, and anxiety
Conditions
Interventions
TCM-driven intervention group:Chinese herbal medicine and psychotherapy
Waitlist control group:Participants in the control group will remain unexposed to the TCM-driven intervention. After 4-month exposure period, all 856 participants will be exposed to the TCM-driven int
Sponsors
Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Cluster-level inclusion criteria 18 geographic districts in Hong Kong will be operationalised as the clusters. No extra eligibility criteria are made at this level as we would like to recruit a wide range of participants with diverse socioeconomic and clinical characteristics to enhance the generalisability of this study. Patient-level inclusion criteria Inclusion criteria: 1) Age between 18 and 65; 2) Experiencing sleep or mood disturbances, operationalised as PHQ-9 score between 5 and 19, GAD-7 score between 5 and 14, or ISI score between 8 and 21; 3) Understand and be able to follow written and oral instructions in Chinese to complete the assessment questionnaires; 4) Willing and able to provide informed consent.
Exclusion criteria
Exclusion criteria: Patient-level exclusion criteria 1) Present with minimal symptoms of depression, anxiety, or sleep disturbances, as indicated by PHQ-9 score 19, GAD-7 score >14, or ISI score>21; 3) History of alcohol and/or substance abuse disorder active in the past 12 months, or history of psychiatric or psychotic disorders such as mania, schizophrenia, bipolar disorder, post-traumatic stress disorder or obsessive-compulsive disorder; 4) History of major neurologic disorder(e.g., Parkinson's disease, Alzheimer's disease or other types of dementia, brain tumour, seizure disorder or delirium episode); 5) Current active suicidal or self-injurious potential necessitating immediate treatment, or score= 1 on the 9th item(suicidal ideation) in PHQ-9; 6) History of serious chronic illness, such as cancer, stroke, heart diseases, end-stage liver and kidney diseases. 7) Pregnancy or lactating female; 8) Currently undergoing prescribed psychotropic medication, psychotherapy or TCM treatments for sleep and mood disturbances; 9) Allergic history to Chinese herbal drugs; 10) Concurrent participation in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of depression;Severity of anxiety;Severity of insomnia;Fecal sample;Urine sample;Objective measurement using wearable device; | — |
Secondary
| Measure | Time frame |
|---|---|
| Health-related quality of life;Severity of perceived stress;Healthcare resource use;TCM body constitution assessment; | — |
Countries
China
Contacts
Public ContactProf. Bian Zhaoxiang
Clinical Division, School of Chinese Medicine, Hong Kong Baptist University
Outcome results
None listed