Establishing TCM Daycare Model and Teaching Mechanism of Depression Patients

China Medical University

Status: Unknown

Conditions: Major Depressive Disorder; Traditional Chinese Medicine

Treatments: Behavioral: acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT04469608

CMUH109-REC3-041

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

TCM clinical daycare model for depression patients

Experimental group

Description:

Tai Chi and Acupuncture and Yoga and Mindfulness

Treatment:

Behavioral: acupuncture

Depression patients

No Intervention group

Description:

Tai Chi and acupuncture and yoga and mindfulness are not added