Self-administered Acupressure for Depression

NCT ID: NCT05631184

Last Updated: 2024-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-15

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Depressive Symptoms Depressive Disorder Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The researchers who perform the assessment and analysis will be blinded to group allocation.

Study Groups

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Self-administered acupressure group

The participants in the self-administered acupressure group will attend an acupressure training course (2 sessions, 2 h each) to learn self-administered acupressure from an acupuncturist in a classroom at the School Nursing, the Hong Kong Polytechnic University. Each class will be conducted in a small group of 4 to 7 participants to enhance interaction and ensure the quality of teaching. Participants will then practice two times a day for 8 weeks.

Group Type EXPERIMENTAL

Self-administered acupressure group

Intervention Type BEHAVIORAL

Self-administered acupressure treatment group was developed on the basis of previous systematic reviews and clinical studies of acupuncture and acupressure for depression. It has robust theoretical basis of TCM. The acupoints selected are commonly used for depression according to a recent systematic review and recommended by other clinical practice guidelines.

Mental health education group

The participants in the comparison group will receive mental health education group from a registered nurse with the same frequency as those in the treatment group (2 sessions, 2 h each) in a classroom at the School Nursing, the Hong Kong Polytechnic University, and will be reminded to follow the mental health practice daily for 8 weeks.

Group Type ACTIVE_COMPARATOR

Mental health education group

Intervention Type BEHAVIORAL

Mental health education training group was developed based on the materials regarding depression and mental health from the Centre of Health Protection, Department of Health, the Government of Hong Kong SAR and reviewed by a clinical psychologist.

Interventions

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Self-administered acupressure group

Self-administered acupressure treatment group was developed on the basis of previous systematic reviews and clinical studies of acupuncture and acupressure for depression. It has robust theoretical basis of TCM. The acupoints selected are commonly used for depression according to a recent systematic review and recommended by other clinical practice guidelines.

Intervention Type BEHAVIORAL

Mental health education group

Mental health education training group was developed based on the materials regarding depression and mental health from the Centre of Health Protection, Department of Health, the Government of Hong Kong SAR and reviewed by a clinical psychologist.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Health and Medical Research Fund

OTHER_GOV

Sponsor Role collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wing Fai Yeung, PhD

Role: PRINCIPAL_INVESTIGATOR

the School of Nursing, the Hong Kong Polytechnic University

Locations

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School of Nursing, the Hong Kong Polytechnic University

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Wing Fai Yeung, PhD

Role: CONTACT

852 2766 4151

Facility Contacts

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Wing-Fai Yeung

Role: primary

85227664151

References

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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.

Reference Type BACKGROUND
PMID: 34623754 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32147048 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32096884 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22231681 (View on PubMed)

Other Identifiers

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19200171

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SelfAcupDep

Identifier Type: -

Identifier Source: org_study_id

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