TCM Health Preservation for Depression

NCT05799586 | Unknown DMC

• 2 other identifiers: TCMHPFDNo.21B2/004A
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

Depression; Traditional Chinese Medicine; Randomized Controlled Trial; Health preservation

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12

• Change in the Perceived Stress Scale (PSS-10)

  Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12

• Change in the Insomnia Severity Index (ISI)

  Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12

• Change in the Fatigue Assessment Scale (FAS)

  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: Baseline, week 6, week 8, week 12

Other Outcomes (1)

• Change in the Credibility/ Expectancy Questionnaire (CEQ)

  Time Frame: Baseline, week 6

Study Arms (2)

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.

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.

Interventions

Traditional Chinese Medicine health preservation group 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.

traditional Chinese medicine health preservation group

Waitlist control group BEHAVIORAL

Usual care

traditional Chinese medicine health preservation group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

School of Nursing, the Hong Kong Polytechnic University

Hong Kong, Hong Kong

RECRUITING

Related Publications (1)

• 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. doi: 10.1186/s12906-025-05217-x. Online ahead of print.

  PMID: 41540402 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Wing Fai Yeung, PhD

CONTACT

852 2766 4151; jerry-wf.yeung@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The researchers who perform the outcome measurement and those researchers who conduct data analysis will be blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 5, 2023
• Study Start: April 1, 2023
• Primary Completion: January 30, 2024
• Study Completion: January 30, 2024
• Last Updated: January 5, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: No time restriction for the data availability
• Access Criteria: The individual participant data will be available upon request

Locations

HK (1)