Depressive, Symptoms Depressive Disorder, DepressionTCMHPFDNCT05799586

TCM Health Preservation for Depression

A study testing Traditional Chinese Medicine health preservation group in people with Depressive, Symptoms Depressive Disorder, Depression, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Depressive, Symptoms Depressive Disorder, Depression
What is being tested?: Traditional Chinese Medicine health preservation group
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 1 siteHong Kong
Study dates: 1 Aug 2023to 30 Jan 2024
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

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.

Who cannot join

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);

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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.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

School of Nursing, the Hong Kong Polytechnic University
Hong Kong

Other trials in Hong Kong

About this study

Official title: Traditional Chinese Medicine Health Preservation Intervention for Depression: A Pilot Randomized Controlled Trial

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.

Conditions: Depressive, Symptoms Depressive Disorder, Depression
Being tested: Traditional Chinese Medicine health preservation group, Waitlist control group
Keywords: Depression, Traditional Chinese Medicine, Randomized Controlled Trial, Health preservation
Medical subject headings: Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Traditional Chinese Medicine health preservation groupBehavioural
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 groupBehavioural
Usual care

Study groups in NCT05799586
Study group	Role	What they receive
traditional Chinese medicine health preservation group	Experimental	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. Receives: Behavioral: Traditional Chinese Medicine health preservation group; Behavioral: Waitlist control group
Waitlist control group	No intervention	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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in the Patient Health Questionnaire (PHQ-9)
The PHQ-9, a self-rated questionnaire to assess the presence and severity of depressive symptoms of an individual during the last 2 weeks on a scale of 0 (not at all) to 3 (nearly every day), with a total score ranging from 0 to 27. A higher score indicates a higher severity of depression symptoms.
Measured: Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12

Secondary outcomes (7)

Change in the Generalized Anxiety Disorder-7 (GAD-7)
The GAD-7 is a four-point Likert scale for identifying probable cases of GAD and assess the severity of symptoms of GAD for the past 2 weeks. The total score of GAD-7 varies from 0 to 21, and responses include "nearly every day," "more than half the days," "several days", and "not at all". The cutoff point of 5, 10, and 15 of GAD-7 might be interpreted as showing mild, moderate, and severe levels of anxiety. Higher scores indicate more severe GAD symptoms.
Measured: Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12
Change in the Perceived Stress Scale (PSS-10)
The PSS-10 is a 10-item scale that is often used for measuring perceived psychological stress. Each item is rated on a 5-point Liket scale during the past month, referring to "4" as "very often" and "0" as never. The total score changes from 0 to 40, with a higher score meaning a higher perceived psychological stress level.
Measured: Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12
Change in the Insomnia Severity Index (ISI)
The ISI is a seven-item self-rating scale to assess the severity of insomnia, distress, and functional impairment associated with insomnia on a 5-point Likert scale. The score of each item of ISI ranges from 0 (no problem) to 4 (very severe problem), and the total score is interpreted as below: absence of insomnia as 0 to 7, sub-threshold insomnia as 8 to14, moderate insomnia as 15 to 21, and severe insomnia as 22 to 28.
Measured: Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12
Change in the Fatigue Assessment Scale (FAS)
The FAS is a 10-item scale that evaluates symptoms of chronic fatigue with a five-point Likert-type scale, which ranges from 1 ("never") to 5 ("always"). A higher score means greater fatigue severity. The total score ranges from 10 to 50. A total FAS score < 22 means no fatigue, a score≥ 22 refers to fatigue.
Measured: Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12
Change in the Short-Form (six-dimension) Health Survey (SF-6D)
The SF-6D covers six domains using a scale of 1 to 6 to evaluate participants' general health and quality of life. Higher scores indicate better health status.
Measured: Time Frame: Baseline, week 6, week 8, week 12
Change in the General Self-Efficacy Scale (GSE)
The GSE scale is a four-point Likert scale with ten items appropriate for evaluating an individual's self-efficacy. It is scored ranging from 1 point to 4 points, referring to "not at all true" to "exactly true" and the total score varied from 10 to 40. A higher score shows a more satisfactory self-efficacy.
Measured: Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12
Change in the Health-Promoting Lifestyle Profile II (HPLP II)
The HPLP II is a scale with 52 items and 6 domains for measuring health-promoting behavior, defined as a multidimensional pattern of self-initiated perceptions and actions that serve to maintain or increase the level of self-actualization, wellness, and fulfillment of a person. The total scores of HPLP-II varies from 52 to 208. Higher HPLP II score denotes better level of health-promoting lifestyle.
Measured: Time Frame: Baseline, week 4, week 6, week 8, week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 202330 Jan 2024

First posted5 Apr 2023
Study start1 Aug 2023
Primary completion30 Jan 2024
Study completion30 Jan 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Depressive, Symptoms Depressive Disorder, DepressionStudies of the same condition, open and under way.
More trials run by The Hong Kong Polytechnic UniversityThe 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: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05799586
Sponsor's protocol ID: TCMHPFD
Other IDs: No.21B2/004A
Acronym: TCMHPFD
Status last verified: Mar 2023
First submitted: 23 Mar 2023
Last updated: 22 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The individual participant data will be available when the study has been published. The individual participant data will be available upon request.

Publications

Ruan JY, Chen X, Cheng HL, Qing WY, Ho JYS, Chen HY, Luo D, Hu L, Chen JY, Wu LY, Chak KY, Lu C, Mak YW, Yeung WF. Perceptions and experiences of a multicomponent traditional Chinese medicine lifestyle medicine program for depression: a qualitative study. BMC Complement Med Ther. 2026 Jan 15;26(1):32. doi: 10.1186/s12906-025-05217-x.
PubMed 41540402

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Traditional Chinese Medicine Health Preservation Intervention for Depression: A Pilot Randomized Controlled Trial
ClinicalTrials.gov ID: NCT05799586
Acronym / sponsor ID: TCMHPFD / TCMHPFD
Conditions: Depressive, Symptoms Depressive Disorder, Depression
Keywords: Depression, Traditional Chinese Medicine, Randomized Controlled Trial, Health preservation
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: The Hong Kong Polytechnic UniversityUniversity, hospital or other
Study start: 1 Aug 2023 (actual)
Primary completion: 30 Jan 2024 (actual)
Study completion: 30 Jan 2024 (actual)
First posted: 5 Apr 2023 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
traditional Chinese medicine health preservation group	Experimental	Behavioral: Traditional Chinese Medicine health preservation group, Behavioral: Waitlist control groupThe 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.
Waitlist control group	No intervention	–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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (10 listed)

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;

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
Traditional Chinese Medicine health preservation groupThe 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.	Behavioural	traditional Chinese medicine health preservation group
Waitlist control groupUsual care	Behavioural	traditional Chinese medicine health preservation group

Primary outcome

Change in the Patient Health Questionnaire (PHQ-9)
Time frame: Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12
The PHQ-9, a self-rated questionnaire to assess the presence and severity of depressive symptoms of an individual during the last 2 weeks on a scale of 0 (not at all) to 3 (nearly every day), with a total score ranging from 0 to 27. A higher score indicates a higher severity of depression symptoms.

7 secondary outcomes

Change in the Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12
Change in the Perceived Stress Scale (PSS-10)
Time frame: Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12
Change in the Insomnia Severity Index (ISI)
Time frame: Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12
Change in the Fatigue Assessment Scale (FAS)
Time frame: Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12
Change in the Short-Form (six-dimension) Health Survey (SF-6D)
Time frame: Time Frame: Baseline, week 6, week 8, week 12
Change in the General Self-Efficacy Scale (GSE)
Time frame: Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12
Change in the Health-Promoting Lifestyle Profile II (HPLP II)
Time frame: Time Frame: Baseline, week 4, week 6, week 8, week 12

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
Derived from this study: PubMed 41540402Ruan JY, Chen X, Cheng HL, Qing WY, Ho JYS, Chen HY, Luo D, Hu L, Chen JY, Wu LY, Chak KY, Lu C, Mak YW, Yeung WF. Perceptions and experiences of a multicomponent traditional Chinese medicine lifestyle medicine program for depression: a qualitative study. BMC Complement Med Ther. 2026 Jan 15;26(1):32. doi: 10.1186/s12906-025-05217-x.
Individual participant dataSharing planned: Yes. The individual participant data will be available when the study has been published. The individual participant data will be available upon request.

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 10 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: finished, as of the sponsor's last update on 22 Sep 2026. 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 Hong Kong. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in the Patient Health Questionnaire (PHQ-9) (time frame: Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05799586, which also lists 1 linked publication.

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 22 Sep 2026.