TCM Health Preservation for Depression (TCMHPFD)

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.

Study Overview

• Status: Recruiting
• Conditions: Depressive, Symptoms Depressive Disorder, Depression
• Intervention / Treatment: Behavioral: Traditional Chinese Medicine health preservation group; Behavioral: Waitlist control group

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wing Fai Yeung, PhD; Phone Number: 852 2766 4151; Email: jerry-wf.yeung@polyu.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • School of Nursing, The Hong Kong Polytechnic University
    • Contact: Wing-Fai Yeung; Phone Number: 27664151; Email: jerry-wf.yeung@polyu.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.; Behavioral: Waitlist control group; Usual care
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	Time Frame: Baseline, week 4, week 6, week 8, week 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Credibility/ Expectancy Questionnaire (CEQ)	The CEQ is a self-reported scale with 6 items and two subscales of treatment credibility and outcome expectancy to measure the participants' treatment credibility and outcome expectancy for improvement. The final scoring of the CEQ is computed by the sum of the items composing each subscale, with a higher quotation referring to higher treatment credibility and outcome expectation. The CEQ taps on participants' affective and cognitive evaluations of treatment satisfaction, credibility, and expectation. The subscale of credibility assesses beliefs about the treatment strength. The expectancy subscale assesses how participants perceive their symptoms will improve during the intervention period.	Time Frame: Baseline, week 6

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): January 30, 2024
• Study Completion (Estimated): January 30, 2024

Study Registration Dates

• First Submitted: March 23, 2023
• First Submitted That Met QC Criteria: March 23, 2023
• First Posted (Actual): April 5, 2023

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Depression; Randomized Controlled Trial; Traditional Chinese Medicine; Health preservation
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: TCMHPFD; No.21B2/004A (Other Grant/Funding Number: the Chinese Medicine Development Fund, Hong Kong Special Administrative Region, China)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The individual participant data will be available when the study has been published. The individual participant data will be available upon request.
• IPD Sharing Time Frame: No time restriction for the data availability
• IPD Sharing Access Criteria: The individual participant data will be available upon request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No