Self-administered Acupressure for Depression

NCT05631184 | Recruiting DMC

• 2 other identifiers: SelfAcupDep19200171
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Symptoms; Depressive Disorder; Depression

Keywords

Depression; Acupressure; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (4)

• Patient Health Questionnaire (PHQ)

  The PHQ-9, a self-rated questionnaire to assess depressive symptoms over 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.

  It will be measured at baseline

• Patient Health Questionnaire (PHQ)

  The PHQ-9, a self-rated questionnaire to assess depressive symptoms over 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.

  It will be measured at week 4 from baseline

• Patient Health Questionnaire (PHQ)

  The PHQ-9, a self-rated questionnaire to assess depressive symptoms over 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.

  It will be measured at week 8 from baseline

• Patient Health Questionnaire (PHQ)

  The PHQ-9, a self-rated questionnaire to assess depressive symptoms over 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.

  It will be measured at week 12 from baseline

Secondary Outcomes (20)

• Hamilton Depression Rating Scale (HDRS)

  It will be measured at baseline

• Hamilton Depression Rating Scale (HDRS)

  It will be measured at week 4 from baseline

• Hamilton Depression Rating Scale (HDRS)

  It will be measured at week 8 from baseline

• Hamilton Depression Rating Scale (HDRS)

  It will be measured at week 12 from baseline

• The Depression Anxiety Stress Scales (DASS-21) - Stress

  It will be measured at baseline

Study Arms (2)

Self-administered acupressure group

EXPERIMENTAL

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.

Behavioral: Self-administered acupressure group

Mental health education group

ACTIVE COMPARATOR

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.

Behavioral: Mental health education group

Interventions

Self-administered acupressure group 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.

Self-administered acupressure group

Mental health education group 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.

Mental health education group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Have the PHQ score of 20 or above (referral information to community psychological services will be provided)
• New onset or change of antidepressant medication or dosage in the last 3 months
• 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.
• Have cognitive impairment diagnosed by the Hong Kong Montreal Cognitive Assessment with a score \< 22
• Skin lesions or infections at the treatment sites
• Significant suicidal risk as rated by the Hamilton Depression Rating Scale item on suicide (score ≥3)
• Pregnant or childbearing potential but not using adequate contraception
• With any major medical condition that causes depression based on the judgement of a psychiatrist.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Health and Medical Research Fund: collaborator

Study Sites (1)

School of Nursing, the Hong Kong Polytechnic University

Hong Kong, Hong Kong

RECRUITING

Related Publications (4)

• 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.

  PMID: 34623754 BACKGROUND

• 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.

  PMID: 32147048 BACKGROUND

• 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.

  PMID: 32096884 BACKGROUND

• 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.

  PMID: 22231681 BACKGROUND

MeSH Terms

Conditions

Depression; Depressive Disorder

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mood Disorders; Mental Disorders

Study Officials

• Wing Fai Yeung, PhD

  the School of Nursing, the Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wing Fai Yeung, PhD

CONTACT

852 2766 4151; jerry-wf.yeung@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The researchers who perform the assessment and analysis will be blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: November 30, 2022
• Study Start: December 15, 2022
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: No time restriction for the data availability.
• Access Criteria: The individual participant data will be available upon request.

Locations

HK (1)