Depressive, Symptoms Depressive Disorder, Depression
Conditions
Keywords
Depression, Traditional Chinese Medicine, Randomized Controlled Trial, Health preservation
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.
Interventions
BEHAVIORALTraditional 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.
BEHAVIORALWaitlist control group
Usual care
Sponsors
The Hong Kong Polytechnic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The researchers who perform the outcome measurement and those researchers who conduct data analysis will be blinded to group allocation.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in the Credibility/ Expectancy Questionnaire (CEQ) | Time Frame: Baseline, week 6 | 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. |
Countries
Hong Kong
Contacts
Primary ContactWing Fai Yeung, PhD
Outcome results
None listed