NCT04469608

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 11, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 14, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

1.6 years

First QC Date

July 9, 2020

Last Update Submit

July 9, 2020

Conditions

Traditional Chinese MedicineMajor Depressive Disorder

Outcome Measures

Primary Outcomes (4)

  • 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)

Study Arms (2)

TCM clinical daycare model for depression patients

EXPERIMENTAL

Tai Chi and Acupuncture and Yoga and Mindfulness

Behavioral: acupuncture

Depression patients

NO INTERVENTION

Tai Chi and acupuncture and yoga and mindfulness are not added

Interventions

acupunctureBEHAVIORAL

Traditional Chinese medicine clinical daycare

Also known as: yoga, mindfulness, Tai Chi
TCM clinical daycare model for depression patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Acupuncture, China Medical University Hospital

Taichung, Taiwan

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Acupuncture TherapyYogaMindfulnessTai Ji

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsMind-Body TherapiesSpiritual TherapiesExercise Movement TechniquesPhysical Therapy ModalitiesCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Yu-Chen Lee

    Department of Acupuncture, China Medical University Hospital Taichung, Taiwan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2020

First Posted

July 14, 2020

Study Start

May 11, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

July 14, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)