Establishing TCM Daycare Model and Teaching Mechanism of Depression Patients

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.

Study Overview

• Status: Unknown
• Conditions: Major Depressive Disorder; Traditional Chinese Medicine
• Intervention / Treatment: Behavioral: acupuncture

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan
    • Department of Acupuncture, China Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TCM clinical daycare model for depression patients; Tai Chi and Acupuncture and Yoga and Mindfulness	Behavioral: acupuncture; Traditional Chinese medicine clinical daycare; Other Names: yoga; mindfulness; Tai Chi
No Intervention: Depression patients; Tai Chi and acupuncture and yoga and mindfulness are not added

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
WHOQOL-Taiwan	Four-dimension: Physiology + Independence; Psychology + Spirituality/Religion/Personal Belief;	Start of treatment (day 0) and end of treatment (week 8)

Collaborators and Investigators

• Sponsor: China Medical University Hospital
• Investigators: Study Director: Yu-Chen Lee, Department of Acupuncture, China Medical University Hospital Taichung, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: July 9, 2020
• First Submitted That Met QC Criteria: July 9, 2020
• First Posted (Actual): July 14, 2020

Study Record Updates

• Last Update Posted (Actual): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 9, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: CMUH109-REC3-041

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No