Establishing TCM Daycare Model and Teaching Mechanism of Depression Patients

NCT ID: NCT04469608

Last Updated: 2020-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-11

Study Completion Date

2021-12-31

Brief Summary

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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

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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.

Conditions

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Traditional Chinese Medicine Major Depressive Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TCM clinical daycare model for depression patients

Tai Chi and Acupuncture and Yoga and Mindfulness

Group Type EXPERIMENTAL

acupuncture

Intervention Type BEHAVIORAL

Traditional Chinese medicine clinical daycare

Depression patients

Tai Chi and acupuncture and yoga and mindfulness are not added

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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acupuncture

Traditional Chinese medicine clinical daycare

Intervention Type BEHAVIORAL

Other Intervention Names

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yoga mindfulness Tai Chi

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yu-Chen Lee

Role: STUDY_DIRECTOR

Department of Acupuncture, China Medical University Hospital Taichung, Taiwan

Locations

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Department of Acupuncture, China Medical University Hospital

Taichung, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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CMUH109-REC3-041

Identifier Type: -

Identifier Source: org_study_id

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