TCM Health Preservation for Depression

NCT ID: NCT05799586

Last Updated: 2024-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-01-30

Brief Summary

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This study aims to evaluate the feasibility and preliminary effects of Traditional Chinese Medicine (TCM) health preservation for depression on depressive symptoms reduction and other health-related outcomes among Hong Kong Chinese adults with depression. Participants in intervention group will receive TCM health preservation course for six weeks (6 sessions, 2 hours each) and practice TCM health preservation during the 6-week follow-up period. Participants in the control group (waitlist control) will receive usual care. After the follow-up assessment, TCM health preservation courses for depression will be provided to them for compensation.

Detailed Description

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Conditions

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Depressive, Symptoms Depressive Disorder, Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two-arm parallel assignment involves two groups of participants. In this study, one group will receive Traditional Chinese Medicine health preservation for depression, and the other group will receive the waitlist control. Thus, during the trial, participants in one group receive Traditional Chinese Medicine health preservation "in parallel" to participants in the waitlist control group.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The researchers who perform the outcome measurement and those researchers who conduct data analysis will be blinded to group allocation.

Study Groups

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traditional Chinese medicine health preservation group

The participants in the traditional Chinese medicine health preservation group will attend six traditional Chinese medicine health preservation courses (2h each per one, for 6 weeks) to learn and experience traditional Chinese medicine health preservation from a registered traditional Chinese medicine practitioner in a classroom at the School Nursing, the Hong Kong Polytechnic University.

Each class will be conducted in a small group of 4 to 6 participants to enhance interaction and ensure the quality of teaching. Participants will then practice traditional Chinese medicine health preservation at home for 6 weeks.

Group Type EXPERIMENTAL

Traditional Chinese Medicine health preservation group

Intervention Type BEHAVIORAL

The traditional Chinese medicine health preservation intervention for depression was developed based on a previous systematic review and meta-analysis of Traditional Chinese medicine based integrated health interventions for depression, traditional Chinese medicine health preservation textbooks, clinical practice guidelines related to traditional Chinese medicine health preservation and traditional Chinese medicine treatment for depression. The content and structure of traditional Chinese medicine health preservation for depression was achieved among Hong Kong traditional Chinese medicine experts via a Delphi study.

Waitlist control group

Intervention Type BEHAVIORAL

Usual care

Waitlist control group

Participants in the waitlist control group will receive usual care during the 6-week waitlist period of intervention, and 6-week waitlist period of follow-up. After the follow-up assessment, they will be provided an equivalent traditional Chinese medicine health preservation for depression.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Traditional Chinese Medicine health preservation group

The traditional Chinese medicine health preservation intervention for depression was developed based on a previous systematic review and meta-analysis of Traditional Chinese medicine based integrated health interventions for depression, traditional Chinese medicine health preservation textbooks, clinical practice guidelines related to traditional Chinese medicine health preservation and traditional Chinese medicine treatment for depression. The content and structure of traditional Chinese medicine health preservation for depression was achieved among Hong Kong traditional Chinese medicine experts via a Delphi study.

Intervention Type BEHAVIORAL

Waitlist control group

Usual care

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Hong Kong Chinese adults aged 18-years-old to 65-years-old;
* diagnosed with moderate level of depression (a score of 10\~20), evaluated by the Patient Health Questionnaire-9 (PHQ-9);
* can communicate in spoken Cantonese and written Chinese;
* willing to provide written informed consent and be able to adhere to the study protocol.

Exclusion Criteria

* being pregnant or during the lactation, or plan to get pregnant;
* new onset or change of antidepressant medication or dosage in the last 3 months;
* PHQ-9 score≥20, meaning a severe level of depression;
* with a previous or present diagnosis of psychotic disorders as screened by the Chinese version of the Structured Clinical Interview for DSM-IV;
* the score of Hong Kong Montreal Cognitive Assessment less than 22;
* significant suicidal risk as rated by the Hamilton Depression Rating Scale item on suicide (score ≥3);
* with diagnosis of illness which can interfere the individuals to participate or adhere to the modified lifestyle;
* with diagnosis of medical conditions, which are not suitable to modify diet or do physical activities recommended by physicians;
* joining in another clinical trial during the study period;
* with any major medical condition that causes depression based on the judgement of the investigator.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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School of Nursing, the Hong Kong Polytechnic University

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Wing Fai Yeung, PhD

Role: CONTACT

852 2766 4151

Facility Contacts

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Wing-Fai Yeung

Role: primary

Other Identifiers

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No.21B2/004A

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

TCMHPFD

Identifier Type: -

Identifier Source: org_study_id

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