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Establishing TCM Daycare Model and Teaching Mechanism of Depression Patients

Primary Purpose

Traditional Chinese Medicine, Major Depressive Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
acupuncture
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traditional Chinese Medicine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Acupuncture, China Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

TCM clinical daycare model for depression patients

Depression patients

Arm Description

Tai Chi and Acupuncture and Yoga and Mindfulness

Tai Chi and acupuncture and yoga and mindfulness are not added

Outcomes

Primary Outcome Measures

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.
Beck Depression Inventory(BDI)
Beck Depression Inventory assesses the degree of depression of 13-80 year olds, as a diagnosis and treatment reference
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.
WHOQOL-Taiwan
Four-dimension: Physiology + Independence; Psychology + Spirituality/Religion/Personal Belief;

Secondary Outcome Measures

Full Information

First Posted
July 9, 2020
Last Updated
July 9, 2020
Sponsor
China Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04469608
Brief Title
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

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 11, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traditional Chinese Medicine, Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TCM clinical daycare model for depression patients
Arm Type
Experimental
Arm Description
Tai Chi and Acupuncture and Yoga and Mindfulness
Arm Title
Depression patients
Arm Type
No Intervention
Arm Description
Tai Chi and acupuncture and yoga and mindfulness are not added
Intervention Type
Behavioral
Intervention Name(s)
acupuncture
Other Intervention Name(s)
yoga, mindfulness, Tai Chi
Intervention Description
Traditional Chinese medicine clinical daycare
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale, HAM-D
Description
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.
Time Frame
Start of treatment (day 0) and end of treatment (week 8)
Title
Beck Depression Inventory(BDI)
Description
Beck Depression Inventory assesses the degree of depression of 13-80 year olds, as a diagnosis and treatment reference
Time Frame
Start of treatment (day 0) and end of treatment (week 8)
Title
Pittsburgh Sleep Quality Inventory
Description
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.
Time Frame
Start of treatment (day 0) and end of treatment (week 8)
Title
WHOQOL-Taiwan
Description
Four-dimension: Physiology + Independence; Psychology + Spirituality/Religion/Personal Belief;
Time Frame
Start of treatment (day 0) and end of treatment (week 8)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of depression according to DSM-IV (Diagnosis code: 296.21-296.30, 300.4) Age 18-65 years, male or female Evaluation of the 21-item Hamilton Rating Scale for Depression (HAMD) 8 points or more 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: 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. Medical history of patients diagnosed with borderline, antisocial personality disorder Take anti-psychotic disorders and anti-epileptic drugs in the past six months. Have or may become pregnant A person with serious suicidal ideation or suicide attempt who must be hospitalized for close monitoring
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-Chen Lee
Organizational Affiliation
Department of Acupuncture, China Medical University Hospital Taichung, Taiwan
Official's Role
Study Director
Facility Information:
Facility Name
Department of Acupuncture, China Medical University Hospital
City
Taichung
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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Establishing TCM Daycare Model and Teaching Mechanism of Depression Patients

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