Self-administered Acupressure for Depression (SAAFD)

Self-administered Acupressure for Depression: A Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Depressive Disorder; Depression; Depressive Symptoms
• Intervention / Treatment: Behavioral: Self-administered acupressure group; Behavioral: Mental health education group

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wing Fai Yeung, PhD; Phone Number: 852 2766 4151; Email: jerry-wf.yeung@polyu.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • School of Nursing, The Hong Kong Polytechnic University
    • Contact: Wing-Fai Yeung; Phone Number: 85227664151; Email: jerry-wf.yeung@polyu.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hamilton Depression Rating Scale (HDRS)	The HDRS is used to assess the severity of depressive symptoms based on the 17-item scale. Eight items are scored on a 5-point scale, ranging from 0 to 4 and nine items are scored from 0 to 2. The total score varies from 0 (the minimum value) to 52 (the maximum value), with a higher total score indicating more severe depression.	It will be measured at baseline
Hamilton Depression Rating Scale (HDRS)	The HDRS is used to assess the severity of depressive symptoms based on the 17-item scale. Eight items are scored on a 5-point scale, ranging from 0 to 4 and nine items are scored from 0 to 2. The total score varies from 0 (the minimum value) to 52 (the maximum value), with a higher total score indicating more severe depression.	It will be measured at week 4 from baseline
Hamilton Depression Rating Scale (HDRS)	The HDRS is used to assess the severity of depressive symptoms based on the 17-item scale. Eight items are scored on a 5-point scale, ranging from 0 to 4 and nine items are scored from 0 to 2. The total score varies from 0 (the minimum value) to 52 (the maximum value), with a higher total score indicating more severe depression.	It will be measured at week 8 from baseline
Hamilton Depression Rating Scale (HDRS)	The HDRS is used to assess the severity of depressive symptoms based on the 17-item scale. Eight items are scored on a 5-point scale, ranging from 0 to 4 and nine items are scored from 0 to 2. The total score varies from 0 (the minimum value) to 52 (the maximum value), with a higher total score indicating more severe depression.	It will be measured at week 12 from baseline
The Depression Anxiety Stress Scales (DASS-21) - Stress	The DASS-21 Stress subscale will be used to measure the emotional states of stress using a 4-point scale ranging from 0 (never) to 3 (almost always).	It will be measured at baseline
The Depression Anxiety Stress Scales (DASS-21) - Stress	The DASS-21 Stress subscale will be used to measure the emotional states of stress using a 4-point scale ranging from 0 (never) to 3 (almost always).	It will be measured at week 4 from baseline
The Depression Anxiety Stress Scales (DASS-21) - Stress	The DASS-21 Stress subscale will be used to measure the emotional states of stress using a 4-point scale ranging from 0 (never) to 3 (almost always).	It will be measured at week 8 from baseline
The Depression Anxiety Stress Scales (DASS-21) - Stress	The DASS-21 Stress subscale will be used to measure the emotional states of stress using a 4-point scale ranging from 0 (never) to 3 (almost always).	It will be measured at week 12 from baseline
The Depression Anxiety Stress Scales (DASS-21) - Anxiety	The DASS-21 Anxiety subscale will be used to measure the emotional states of anxiety using a 4-point scale ranging from 0 (never) to 3 (almost always).	It will be measured at baseline
The Depression Anxiety Stress Scales (DASS-21) - Anxiety	The DASS-21 Anxiety subscale will be used to measure the emotional states of anxiety using a 4-point scale ranging from 0 (never) to 3 (almost always).	It will be measured at week 4 from baseline
The Depression Anxiety Stress Scales (DASS-21) - Anxiety	The DASS-21 Anxiety subscale will be used to measure the emotional states of anxiety using a 4-point scale ranging from 0 (never) to 3 (almost always).	It will be measured at week 8 from baseline
The Depression Anxiety Stress Scales (DASS-21) - Anxiety	The DASS-21 Anxiety subscale will be used to measure the emotional states of anxiety using a 4-point scale ranging from 0 (never) to 3 (almost always).	It will be measured at week 12 from baseline
The Insomnia Severity Index (ISI)	The ISI is a seven-item self-rating scale to assess the severity of insomnia, distress, and functional impairment associated with insomnia on a 5-point Likert scale.	It will be measured at baseline
The Insomnia Severity Index (ISI)	The ISI is a seven-item self-rating scale to assess the severity of insomnia, distress, and functional impairment associated with insomnia on a 5-point Likert scale.	It will be measured at week 4 from baseline
The Insomnia Severity Index (ISI)	The ISI is a seven-item self-rating scale to assess the severity of insomnia, distress, and functional impairment associated with insomnia on a 5-point Likert scale.	It will be measured at week 8 from baseline
The Insomnia Severity Index (ISI)	The ISI is a seven-item self-rating scale to assess the severity of insomnia, distress, and functional impairment associated with insomnia on a 5-point Likert scale.	It will be measured at week 12 from baseline
The Short-Form (six-dimension) Health Survey (SF-6D)	The SF-6D covers six domains using a scale of 1 to 6 to evaluate participants' general health and quality of life.	It will be measured at baseline
The Short-Form (six-dimension) Health Survey (SF-6D)	The SF-6D covers six domains using a scale of 1 to 6 to evaluate participants' general health and quality of life.	It will be measured at week 4 from baseline
The Short-Form (six-dimension) Health Survey (SF-6D)	The SF-6D covers six domains using a scale of 1 to 6 to evaluate participants' general health and quality of life.	It will be measured at week 8 from baseline
The Short-Form (six-dimension) Health Survey (SF-6D)	The SF-6D covers six domains using a scale of 1 to 6 to evaluate participants' general health and quality of life.	It will be measured at week 12 from baseline

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Collaborators: Health and Medical Research Fund
• Investigators: Principal Investigator: Wing Fai Yeung, PhD, the School of Nursing, the Hong Kong Polytechnic University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2022
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 14, 2022
• First Submitted That Met QC Criteria: November 20, 2022
• First Posted (Actual): November 30, 2022

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Depression; Randomized Controlled Trial; Acupressure
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: SelfAcupDep; 19200171 (Other Grant/Funding Number: Health and Medical Research Fund)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The individual participant data will be available when the study has been published. The individual participant data will be available upon request.
• IPD Sharing Time Frame: No time restriction for the data availability.
• IPD Sharing Access Criteria: The individual participant data will be available upon request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No