TCM Health Preservation for Depression

Not Applicable

Recruiting

• Conditions: Depressive, Symptoms Depressive Disorder, Depression

• Registration Number: NCT05799586
• Lead Sponsor: The Hong Kong Polytechnic University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-23
• Study First Submitted QC: 2023-03-23
• Study Start: 2023-04-01
• Study First Posted: 2023-04-05
• Last Update Submitted: 2024-01-03
• Last Update Posted: 2024-01-05
• Primary Completion: 2024-01-30
• Study Completion: 2024-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in the Patient Health Questionnaire (PHQ-9)	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.

Secondary Outcome Measures

Name	Time	Method
Change in the Generalized Anxiety Disorder-7 (GAD-7)	Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12	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 Fatigue Assessment Scale (FAS)	Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12	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 Perceived Stress Scale (PSS-10)	Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12	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)	Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12	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 Short-Form (six-dimension) Health Survey (SF-6D)	Time Frame: Baseline, week 6, week 8, week 12	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)	Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12	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)	Time Frame: Baseline, week 4, week 6, week 8, week 12	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.

Trial Locations

Locations (1)

School of Nursing, the Hong Kong Polytechnic University; 🇭🇰 Hong Kong, Hong Kong