Clinical trial NCT05799586: TCM Health Preservation for Depression
Official title: Traditional Chinese Medicine Health Preservation Intervention for Depression: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depressive, Symptoms Depressive Disorder, Depression
Keywords: Depression
Traditional Chinese Medicine
Randomized Controlled Trial
Health preservation
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2023-04-05
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in the Patient Health Questionnaire (PHQ-9)
timeFrame: Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12
Secondary outcomes:
measure: Change in the Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12
measure: Change in the Perceived Stress Scale (PSS-10)
timeFrame: Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12
measure: Change in the Insomnia Severity Index (ISI)
timeFrame: Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12
measure: Change in the Fatigue Assessment Scale (FAS)
timeFrame: Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12
measure: Change in the Short-Form (six-dimension) Health Survey (SF-6D)
timeFrame: Time Frame: Baseline, week 6, week 8, week 12
measure: Change in the General Self-Efficacy Scale (GSE)
timeFrame: Time Frame: Baseline, week 2, week 4, week 6, week 8, week 12
measure: Change in the Health-Promoting Lifestyle Profile II (HPLP II)
timeFrame: Time Frame: Baseline, week 4, week 6, week 8, week 12
Other outcomes:
measure: Change in the Credibility/ Expectancy Questionnaire (CEQ)
timeFrame: Time Frame: Baseline, week 6
Locations:
city: Hong Kong
country: Hong Kong
facility: School of Nursing, the Hong Kong Polytechnic University
Study officials:
References: