TCM Health Preservation for Depression (TCMHPFD)

The Hong Kong Polytechnic University

Status: Enrolling

Conditions: Depressive, Symptoms Depressive Disorder, Depression

Treatments: Behavioral: Waitlist control group; Behavioral: Traditional Chinese Medicine health preservation group

Study type: Interventional

Funder types: Other

Identifiers

NCT05799586

TCMHPFD

No.21B2/004A (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups

traditional Chinese medicine health preservation group

Experimental group

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.

Treatment:

Behavioral: Waitlist control group

Behavioral: Traditional Chinese Medicine health preservation group

Waitlist control group

No Intervention group

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.