Clinical trial NCT05631184: Self-administered Acupressure for Depression
Official title: Self-administered Acupressure for Depression: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depressive Symptoms
Depressive Disorder
Depression
Keywords: Depression
Acupressure
Randomized Controlled Trial
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Health and Medical Research Fund
First posted: 2022-11-30
Enrollment: 250
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 self-administered acupressure, and the other group will receive the mental health education. So during the trial, participants in one group receive self-administered acupressure "in parallel" to participants in the other group, who receive the mental health education.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to examine the effects of self-administered acupressure intervention for alleviating depressive symptoms among people with depression. It is hypothesized that the self-administered acupressure group would have a great improvement in depressive symptoms as measured by the Patient Health Questionnaire compared with the mental health education group across the 12-week intervention period.

The main questions it aims to answer are:

* Is the self-administered acupressure intervention more effective for alleviating depression and other related outcomes compared to the mental health education group among depressed individuals?
* Is the self-administered acupressure intervention acceptable and feasible for depressed individuals to alleviate depression? Participants will be randomized into self-administered acupressure group or mental health education group based on the group allocation with a 1:1 ratio. Participants will attend two weekly 120-min self-administered acupressure training or mental health education, respectively.


Eligibility criteria: Inclusion Criteria:

1. Hong Kong residents aged 18 to 65
2. Can communicate in Cantonese and comprehend written Chinese
3. Have moderate or above-level depression as measured by the PHQ-9 with a score of 10 or above
4. Willing to give informed consent and comply with the trial protocol.

Exclusion Criteria:

1. Have the PHQ score of 20 or above (referral information to community psychological services will be provided)
2. New onset or change of antidepressant medication or dosage in the last 3 months
3. Previous or current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder as screened using the Chinese version of the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders.
4. Have cognitive impairment diagnosed by the Hong Kong Montreal Cognitive Assessment with a score \< 22
5. Skin lesions or infections at the treatment sites
6. Significant suicidal risk as rated by the Hamilton Depression Rating Scale item on suicide (score ≥3)
7. Pregnant or childbearing potential but not using adequate contraception
8. With any major medical condition that causes depression based on the judgement of a psychiatrist.

Primary outcomes:
measure: Patient Health Questionnaire (PHQ)
timeFrame: It will be measured at baseline
measure: Patient Health Questionnaire (PHQ)
timeFrame: It will be measured at week 4 from baseline
measure: Patient Health Questionnaire (PHQ)
timeFrame: It will be measured at week 8 from baseline
measure: Patient Health Questionnaire (PHQ)
timeFrame: It will be measured at week 12 from baseline
Secondary outcomes:
measure: Hamilton Depression Rating Scale (HDRS)
timeFrame: It will be measured at baseline
measure: Hamilton Depression Rating Scale (HDRS)
timeFrame: It will be measured at week 4 from baseline
measure: Hamilton Depression Rating Scale (HDRS)
timeFrame: It will be measured at week 8 from baseline
measure: Hamilton Depression Rating Scale (HDRS)
timeFrame: It will be measured at week 12 from baseline
measure: The Depression Anxiety Stress Scales (DASS-21) - Stress
timeFrame: It will be measured at baseline
measure: The Depression Anxiety Stress Scales (DASS-21) - Stress
timeFrame: It will be measured at week 4 from baseline
measure: The Depression Anxiety Stress Scales (DASS-21) - Stress
timeFrame: It will be measured at week 8 from baseline
measure: The Depression Anxiety Stress Scales (DASS-21) - Stress
timeFrame: It will be measured at week 12 from baseline
measure: The Depression Anxiety Stress Scales (DASS-21) - Anxiety
timeFrame: It will be measured at baseline
measure: The Depression Anxiety Stress Scales (DASS-21) - Anxiety
timeFrame: It will be measured at week 4 from baseline
measure: The Depression Anxiety Stress Scales (DASS-21) - Anxiety
timeFrame: It will be measured at week 8 from baseline
measure: The Depression Anxiety Stress Scales (DASS-21) - Anxiety
timeFrame: It will be measured at week 12 from baseline
measure: The Insomnia Severity Index (ISI)
timeFrame: It will be measured at baseline
measure: The Insomnia Severity Index (ISI)
timeFrame: It will be measured at week 4 from baseline
measure: The Insomnia Severity Index (ISI)
timeFrame: It will be measured at week 8 from baseline
measure: The Insomnia Severity Index (ISI)
timeFrame: It will be measured at week 12 from baseline
measure: The Short-Form (six-dimension) Health Survey (SF-6D)
timeFrame: It will be measured at baseline
measure: The Short-Form (six-dimension) Health Survey (SF-6D)
timeFrame: It will be measured at week 4 from baseline
measure: The Short-Form (six-dimension) Health Survey (SF-6D)
timeFrame: It will be measured at week 8 from baseline
measure: The Short-Form (six-dimension) Health Survey (SF-6D)
timeFrame: It will be measured at week 12 from baseline
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: School of Nursing, the Hong Kong Polytechnic University
Study officials:
affiliation: the School of Nursing, the Hong Kong Polytechnic University
name: Wing Fai Yeung, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang Z, Li S, Meng H, Wang Y, Zhang Y, Wu M, Chen Y, Rong P, Wang Y. Efficacy and safety of acupuncture in the treatment of depression: A systematic review of clinical research. Anat Rec (Hoboken). 2021 Nov;304(11):2436-2453. doi: 10.1002/ar.24783. Epub 2021 Oct 8.
citation: Fernandez-Chinguel JE, Goicochea-Lugo S, Villarreal-Zegarra D, Taype-Rondan A, Zafra-Tanaka JH. Acupuncture for major depressive disorder: A review of the recommendations stated at clinical practice guidelines. Complement Ther Med. 2020 Mar;49:102321. doi: 10.1016/j.ctim.2020.102321. Epub 2020 Jan 24.
citation: Cheung DST, Tiwari A, Yeung WF, Yu DSF, So MKP, Chau PH, Wang XM, Lum TYS, Yuk Fung HYK, Ng BYM, Zhang ZJ, Lao L. Self-Administered Acupressure for Caregivers of Older Family Members: A Randomized Controlled Trial. J Am Geriatr Soc. 2020 Jun;68(6):1193-1201. doi: 10.1111/jgs.16357. Epub 2020 Feb 25.
citation: Kroenke K. Enhancing the clinical utility of depression screening. CMAJ. 2012 Feb 21;184(3):281-2. doi: 10.1503/cmaj.112004. Epub 2012 Jan 9. No abstract available.