Traditional Chinese MedicineNCT04469608
Establishing TCM Daycare Model and Teaching Mechanism of Depression Patients
A study testing acupuncture in people with Traditional Chinese Medicine and Major Depressive Disorder, run by China Medical University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traditional Chinese Medicine, Major Depressive Disorder
- What is being tested?
- acupuncture
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 May 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Acupuncture, China Medical University Hospital
Taichung
About this study
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.
Read the 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.
- Being tested
- acupuncture
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureBehavioural
Also called yoga, mindfulness, Tai Chi
Traditional Chinese medicine clinical daycare
| Study group | Role | What they receive |
|---|---|---|
| TCM clinical daycare model for depression patients | Experimental | Tai Chi and Acupuncture and Yoga and Mindfulness Receives: Behavioral: acupuncture |
| Depression patients | No intervention | Tai Chi and acupuncture and yoga and mindfulness are not added |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: Start of treatment (day 0) and end of treatment (week 8)
WHOQOL-Taiwan
Four-dimension: Physiology + Independence; Psychology + Spirituality/Religion/Personal Belief;
Measured: Start of treatment (day 0) and end of treatment (week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start11 May 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traditional Chinese MedicineStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Chen Lee, Study director, Department of Acupuncture, China Medical University Hospital Taichung, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04469608
- Sponsor's protocol ID
- CMUH109-REC3-041
- Status last verified
- Jul 2020
- First submitted
- 9 Jul 2020
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing TCM Daycare Model and Teaching Mechanism of Depression Patients
- ClinicalTrials.gov ID
- NCT04469608
- Acronym / sponsor ID
- CMUH109-REC3-041
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 11 May 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 14 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCM clinical daycare model for depression patients | Experimental | Behavioral: acupunctureTai Chi and Acupuncture and Yoga and Mindfulness |
| Depression patients | No intervention | –Tai Chi and acupuncture and yoga and mindfulness are not added |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupunctureAlso: yoga, mindfulness, Tai ChiTraditional Chinese medicine clinical daycare | Behavioural | TCM clinical daycare model for depression patients |
Primary outcome
Hamilton Depression Rating Scale, HAM-D
Time frame: Start of treatment (day 0) and end of treatment (week 8)
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)
Time frame: Start of treatment (day 0) and end of treatment (week 8)
Beck Depression Inventory assesses the degree of depression of 13-80 year olds, as a diagnosis and treatment reference
Pittsburgh Sleep Quality Inventory
Time frame: Start of treatment (day 0) and end of treatment (week 8)
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
Time frame: Start of treatment (day 0) and end of treatment (week 8)
Four-dimension: Physiology + Independence; Psychology + Spirituality/Religion/Personal Belief;
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Chen Lee study director
Department of Acupuncture, China Medical University Hospital Taichung, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture in people with Traditional Chinese Medicine and Major Depressive Disorder, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Rating Scale, HAM-D (time frame: Start of treatment (day 0) and end of treatment (week 8)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020; AzTrials last refreshed its copy on 8 Nov 2026.