Establishing TCM Daycare Model and Teaching Mechanism of Depression Patients

Major Depressive Disorder Clinical Trial

Official title:

Establishing TCM Daycare Model and Teaching Mechanism of Depression Patients

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04469608
• Other study ID #: CMUH109-REC3-041
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 11, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2020
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Traditional Chinese Medicine

Intervention

Behavioral:
• acupuncture
Traditional Chinese medicine clinical daycare

Locations

Country	Name	City	State
Taiwan	Department of Acupuncture, China Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Rating Scale, HAM-D	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.	Start of treatment (day 0) and end of treatment (week 8)
Primary	Beck Depression Inventory(BDI)	Beck Depression Inventory assesses the degree of depression of 13-80 year olds, as a diagnosis and treatment reference	Start of treatment (day 0) and end of treatment (week 8)
Primary	Pittsburgh Sleep Quality Inventory	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.	Start of treatment (day 0) and end of treatment (week 8)
Primary	WHOQOL-Taiwan	Four-dimension: Physiology + Independence; Psychology + Spirituality/Religion/Personal Belief;	Start of treatment (day 0) and end of treatment (week 8)