Back to resultsTCM Health Preservation for Depression (TCMHPFD)
Primary Purpose
Depressive, Symptoms Depressive Disorder, Depression
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Traditional Chinese Medicine health preservation group
Waitlist control group
Sponsored by
About this trial
This is an interventional treatment trial for Depressive, Symptoms Depressive Disorder, Depression focused on measuring Depression, Traditional Chinese Medicine, Randomized Controlled Trial, Health preservation
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
traditional Chinese medicine health preservation group
Waitlist control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05799586
First Posted
March 23, 2023
Last Updated
April 20, 2023
Sponsor
The Hong Kong Polytechnic University
1. Study Identification
Unique Protocol Identification Number
NCT05799586
Brief Title
TCM Health Preservation for Depression
Acronym
TCMHPFD
Official Title
Traditional Chinese Medicine Health Preservation Intervention for Depression: A Pilot Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 30, 2023 (Anticipated)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
January 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Hong Kong Polytechnic University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive, Symptoms Depressive Disorder, Depression
Keywords
Depression, Traditional Chinese Medicine, Randomized Controlled Trial, Health preservation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
The researchers who perform the outcome measurement and those researchers who conduct data analysis will be blinded to group allocation.
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
traditional Chinese medicine health preservation group
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Traditional Chinese Medicine health preservation group
Intervention Description
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
Intervention Name(s)
Waitlist control group
Intervention Description
Usual care
Primary Outcome Measure Information:
Title
Change in the Patient Health Questionnaire (PHQ-9)
Description
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
Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12
Secondary Outcome Measure Information:
Title
Change in the Generalized Anxiety Disorder-7 (GAD-7)
Description
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
Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12
Title
Change in the Perceived Stress Scale (PSS-10)
Description
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
Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12
Title
Change in the Insomnia Severity Index (ISI)
Description
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
Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12
Title
Change in the Fatigue Assessment Scale (FAS)
Description
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
Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12
Title
Change in the Short-Form (six-dimension) Health Survey (SF-6D)
Description
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
Time Frame: Baseline, week 6, week 8, week 12
Title
Change in the General Self-Efficacy Scale (GSE)
Description
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
Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12
Title
Change in the Health-Promoting Lifestyle Profile II (HPLP II)
Description
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
Time Frame: Baseline, week 4, week 6, week 8, week 12
Other Pre-specified Outcome Measures:
Title
Change in the Credibility/ Expectancy Questionnaire (CEQ)
Description
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
Time Frame: Baseline, week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wing Fai Yeung, PhD
Phone
852 2766 4151
Email
jerry-wf.yeung@polyu.edu.hk
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
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TCM Health Preservation for Depression
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