Anxiety Depression, Sleep
Conditions
Keywords
Depression, Acupuncture, Antidepressants, anxiety, sleep
Brief summary
The main objective of this study is to compare medication (usual care; active comparator) with acupuncture (as experimental intervention) to identify the most (cost)effective and environmentally sustainable intervention to reduce depression, anxiety and comorbid sleep disorders in adults (18-65) in China.
Detailed description
The main objective of this study is to compare medication (usual care; active comparator) with acupuncture (as experimental intervention) to identify the most (cost)effective and environmentally sustainable intervention to reduce depression, anxiety and comorbid sleep disorders in adults (18-65) in China. In recent years, there has been a growing focus on how to alleviate emotional distress and promote psychological well-being, prompting researchers to find the most effective treatment from a clinical perspective. At the same time, the healthcare system is also facing financial pressures and environmental sustainability challenges, which requires multiple factors to be considered when choosing patient care options. Therefore, this project intends to compare the clinical efficacy, cost-effectiveness, and environmental footprint of acupuncture versus medication in alleviating anxiety and depressive symptoms in Chinese adults (aged 18 years and above). These analyses provide the necessary basis for the development of rigorous evidence-based policy recommendations. The World Health Organization (WHO) and the "Healthy China 2030" Plan Outline both attach great importance to integrating the traditional Chinese medicine (TCM) system into the overall medical system. As an important part of TCM, acupuncture is included in the WHO Traditional Medicine Strategy and is encouraged to play a more mainstream role in healthcare treatments. However, neither WHO nor Healthy China 2030 have yet to clarify the role of acupuncture in the specific field of mental health. This lack of rigorous scientific evidence related to mental health, and acupuncture in particularly, co-exists with the broader growing focus on "complementary and alternative medicine" (CAM), which includes acupuncture, other forms of traditional Chinese medicine and other traditional medicine systems worldwide. CAM and Western medicine differ significantly in terms of concepts, methods, and resource use. CAM is often hypothesized to have a low direct environmental impact due to the use of natural ingredients and the emphasis on prevention, but its actual environmental footprint still needs to be rigorously evaluated. If the efficacy is insufficient (which is often also hypothesized to be the case), it may prolong the course of the disease, increase patient suffering, financial burden and environmental footprint. At present, CAM mainly shows validated efficacy in physical health. For example, some studies have shown that acupuncture has certain effects in relieving chronic lower back pain and arthritis pain. Mind-body practices such as meditation and yoga also have a positive impact on cardiovascular health, such as lowering blood pressure and improving respiratory efficiency. However, in the field of mental health, relevant research is insufficient. The available evidence is often methodologically limited and limited by research bias based on Western samples, making it difficult to fully assess the global applicability of CAM. Although there is preliminary evidence that acupuncture may have positive effects on mental health, there is still a lack of systematic comparative studies, especially direct comparisons with mainstream Western therapies and differences in their environmental effects.
Interventions
DRUGPsychotropic Drugs
1. Trazodone (25-150 mg; once daily, 30 minutes before bedtime) or mirtazapine (3.75-30 mg; once daily, 30 minutes before bedtime) 2. Zopiclone (5-10 mg; once daily, taken at bedtime) or lorazepam (0.25-1 mg, once daily, taken at bedtime) Patients may also be prescribed 3. Escitalopram oxalate tablets (10-20 mg; once daily, 30 minutes after breakfast) in cases where Insomnia is Caused by Depressive and Anxious Symptoms The treatment is planned for 4 weeks. After 2 weeks, patients are invited for a check-in visit but there will be no change in the treatment prescribed for 4 weeks
OTHERAcupuncture
Manual acupuncture (no sham) will be compared to medication. Acupuncture Points Selected: Bilateral Baihui (GV20), Yintang (GV29), Anmian (EX-HN22), Shenmen (HT7), Neiguan (PC6), Sanyinjiao (SP6), Zhaohai (KI6), Shenmai (BL62), and Taichong (LR3) (29, 30) Operational Procedure: 1. Patient Position: Supine position. 2. Needles: Single-use sterile needles (Specifications: 0.25 mm × 40 mm; Brand: Wuxi Jiajian). 3. Disinfection: Strict disinfection protocols must be performed prior to needling. 4. Needling Technique: After insertion, lifting-thrusting and twirling-rotating manipulation techniques are applied to elicit De Qi (the arrival of Qi). 5. Needle Retention Time: 20 minutes. 6. Treatment Regimen: * Frequency: 3 sessions per week (Monday, Wednesday, and Friday). * Course of Treatment: 9 to 10 sessions per course.
Sponsors
Duke Kunshan University
Kunshan Hospital of Traditional Chinese Medicine
Kunshan Mental Health Center
National Natural Science Foundation of China
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
It was observed in preliminary stages of the trial that patients have very strong preferences for either acupuncture or medication. Many patients refused to be randomly assigned to treatment. Thus, the trial was changed to a preference-based trial, which allows for some patients to choose which treatment they prefer (N=60 per group in a total of 120 non-randomized patients), and for patients without a strong preference, these are randomly allocated to different treatments (N=30 per group in a total of 60 randomized patients).
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Chinese nationals 18-65 years old 2. At least one of the screening scores below suggestive of depression/anxiety tendencies: 1. Depressive state: Depression Self-Rating Scale (SDS) raw score ≥43; standard score ≥53 (27) 2. Anxiety state: Anxiety Self-Rating Scale (SAS) raw score ≥40; standard score ≥50 (28) Note: (standard score = raw score X 1.25)
Exclusion criteria
1. Patients with severe comorbid physical illnesses that prevent them from completing the full course of treatment; 2. Patients with a risk of suicide; 3. Patients with a history of head trauma, loss of consciousness, or severe mental disorders; 4. Patients with drugs or alcohol abuse; 5. Patients who have received physical treatment methods within the past 3 months; 6. Patients who have received antidepressant or antipsychotic medication treatment within the past 3 months; 7. Patients with severe skin lesions or skin diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Between-groups and within-subjects mean change in depression | Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3). | Changes in depression will be measured with Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a versatile tool for screening, diagnosing, monitoring, and assessing depression severity. The prompt instruction is: Over the last 2 weeks, how often have you been bothered by any of the following problems? Example of items: "Little interest or pleasure in doing things"; "Feeling down, depressed, or hopeless". Scoring options include: 0=not at all, 1=several days, 2=more than half of the days, 3=nearly every day. Lower mean values suggest aggregate reductions in depression. |
| Between-groups and within-subjects mean change in anxiety | Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3). | Change in anxiety will be measured with the Generalised Anxiety Disorder Assessment (GAD-7). GAD-7 is a brief measure for symptoms of anxiety, based on the generalised anxiety disorder (GAD) diagnostic criteria described in the Diagnostic and Statistical Manual of Mental Disorders (DSM). The prompt instruction is: Over the last 2 weeks, how often have you been bothered by any of the following problems? Example of items: "Feeling nervous, anxious, or on edge"; "Not being able to stop or control worrying". Scoring options include: 0=not at all, 1=several days, 2=more than half of the days, 3=nearly every day. Lower mean values suggest aggregate reductions in anxiety. |
| Between-groups and within-subjects mean change in sleep condition | Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3). | Changes in sleep will be measured with Sleep Condition Indicator (SCI). The Sleep Condition Indicator (SCI) is an eight-item rating scale that was developed to screen for insomnia disorder based on DSM-5 criteria. It has been shown previously to have good psychometric properties among several language translations. The prompt instruction is: Thinking about a typical night in the last month... Example of items: "How long does it take you to fall asleep?"; "How would you rate your sleep quality?". Scoring options from 0 to 4, SCI total from minimum 0 to maximum 32; a higher score means better sleep. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Between-groups Comparative Environmental Footprint | After treatment is concluded (Time 1) and 3-months follow-up (Time 2) | To calculate the comparative environmental impacts of acupuncture versus antidepressants to reduce postpartum depression, we will consider a range of factors including list of resources, quantities used (e.g., electricity, water), emissions factors and indirect emissions e.g., supply chain. We will follow validated calculation methods for healthcare, which will allow to identify, measure and evaluate the total emission impacts of different health treatments. This calculation will document all resources used in both arms of the trial, including medications, acupuncture materials, travel, infrastructure use (e.g., clinic space), and any other resources engaged during the trial. Both treatments have waste that must be managed. We will normalize the footprint data per patient or per unit of clinical improvement to facilitate a direct comparison between the two treatments. The final single, combined value will be reported as CO2 emissions in tonnes. |
| Between-groups and within-subjects mean change in Side Effects | Collected at baseline (T0) compared to post-treatment (T1), 3-months follow-up (T2) and 6-months follow-up (T3). | Participants will be asked to rate the frequency of possible side effects. The prompt instruction is: How often have you been bothered by these problems in the last 2 weeks? Nausea; Headache; Tremor/ shaking hands; Heart palpitations; Constipation; Dizziness; Indigestion; Pain; Insomnia; Fatigue. Scoring options include: 0=not at all, 1=several days, 2=more than half of the days, 3=nearly every day. Lower values suggest lower rates of side effects. |
Countries
China
Contacts
CONTACTClaudia F. Nisa
PRINCIPAL_INVESTIGATORClaudia Nisa
Duke Kunshan University
Outcome results
None listed