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Establishing TCM Daycare Model and Teaching Mechanism of Depression Patients

Establishing TCM Daycare Model and Teaching Mechanism of Depression Patients

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04469608
Enrollment
80
Registered
2020-07-14
Start date
2020-05-11
Completion date
2021-12-31
Last updated
2020-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder, Traditional Chinese Medicine

Brief summary

The teaching platform of the TCM daycare clinics for depression patients will provide a good clinical training environment for the trainees. They can learn how to take care of depression patients by the lectures and the clinical practice experiences in the daycare clinics. They can also learn a holistic approach, a patient-centered healthcare service. This teaching model will strengthen the clinical training of TCM and enhance the international competitiveness of TCM doctors.

Detailed description

Major depressive disorder (MDD) is a serious psychiatric illness with a high lifetime prevalence rate and causes major clinical, social and economic burden to patients and their family. Despite that more than 40 antidepressants with various mechanisms are available on the market, half of patients fail to achieve remission with optimized medication treatment because of unsatisfactory efficacy, frequent intolerability and poor compliance of pharmacotherapies. However, Traditional Chinese medicine (TCM) is a safe and effective therapy which has many previous evidences to improve the treatment of depression. The aim of this project is to build up a TCM clinical daycare model for depression patients, and to establish a teaching platform for TCM trainees. The TCM daycare model will be provided by a team organized by doctors, nurses, pharmacists, psychologist, nutritionist and case managers. This model will provide a comprehensive TCM care system to improve the clinical symptoms and quality of life of depression patients.

Interventions

BEHAVIORALacupuncture

Traditional Chinese medicine clinical daycare

Sponsors

China Medical University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

1. Diagnosis of depression according to DSM-IV (Diagnosis code: 296.21-296.30, 300.4) 2. Age 18-65 years, male or female 3. Evaluation of the 21-item Hamilton Rating Scale for Depression (HAMD) 8 points or more 4. Fully understand the entire research plan and sign the informed consent form (aged 18-20 years old must be jointly signed by a legal agent)

Exclusion criteria

1. Have a diagnosis of mental illness other than depression in the last or past 6 months, including unipolar major depression, including dyslexia, organic mental disorder, impulse control disorder, substance use disorder, bipolar mental disorder or substance abuse. 2. Medical history of patients diagnosed with borderline, antisocial personality disorder 3. Take anti-psychotic disorders and anti-epileptic drugs in the past six months. 4. Have or may become pregnant 5. A person with serious suicidal ideation or suicide attempt who must be hospitalized for close monitoring

Design outcomes

Primary

MeasureTime frameDescription
Hamilton Depression Rating Scale, HAM-DStart of treatment (day 0) and end of treatment (week 8)Each question of HAM-D is rated 3-5 points, eight questions are 0-2 points, nine questions are 0-4 points, and the total score is 0-52 points. Evaluate the emotional and physical and mental states observed in the case during the most recent week and interview.
Beck Depression Inventory(BDI)Start of treatment (day 0) and end of treatment (week 8)Beck Depression Inventory assesses the degree of depression of 13-80 year olds, as a diagnosis and treatment reference
Pittsburgh Sleep Quality InventoryStart of treatment (day 0) and end of treatment (week 8)It is suitable for the evaluation of sleep quality in patients with sleep disorders and mental disorders, and is also suitable for the evaluation of sleep quality in ordinary people.
WHOQOL-TaiwanStart of treatment (day 0) and end of treatment (week 8)Four-dimension: Physiology + Independence; Psychology + Spirituality/Religion/Personal Belief;

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026