Clinical trial NCT04469608: Establishing TCM Daycare Model and Teaching Mechanism of Depression Patients
Official title: Establishing TCM Daycare Model and Teaching Mechanism of Depression Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Traditional Chinese Medicine
Major Depressive Disorder
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2020-07-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hamilton Depression Rating Scale, HAM-D
timeFrame: Start of treatment (day 0) and end of treatment (week 8)
measure: Beck Depression Inventory(BDI)
timeFrame: Start of treatment (day 0) and end of treatment (week 8)
measure: Pittsburgh Sleep Quality Inventory
timeFrame: Start of treatment (day 0) and end of treatment (week 8)
measure: WHOQOL-Taiwan
timeFrame: Start of treatment (day 0) and end of treatment (week 8)
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Department of Acupuncture, China Medical University Hospital
Study officials:
affiliation: Department of Acupuncture, China Medical University Hospital Taichung, Taiwan
name: Yu-Chen Lee
role: STUDY_DIRECTOR
References: