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Self-administered Acupressure for Depression (SAAFD)

Primary Purpose

Depressive Symptoms, Depressive Disorder, Depression

Status
Not yet recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Self-administered acupressure group
Mental health education group
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Symptoms focused on measuring Depression, Acupressure, Randomized Controlled Trial

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • School of Nursing, the Hong Kong Polytechnic University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Self-administered acupressure group

Mental health education group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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).
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).
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).
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).
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).
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).
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
November 14, 2022
Last Updated
December 15, 2022
Sponsor
The Hong Kong Polytechnic University
Collaborators
Health and Medical Research Fund
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1. Study Identification

Unique Protocol Identification Number
NCT05631184
Brief Title
Self-administered Acupressure for Depression
Acronym
SAAFD
Official Title
Self-administered Acupressure for Depression: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 15, 2022 (Anticipated)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
Health and Medical Research Fund

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms, Depressive Disorder, Depression
Keywords
Depression, Acupressure, Randomized Controlled Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
The researchers who perform the assessment and analysis will be blinded to group allocation.
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Self-administered acupressure group
Arm Type
Experimental
Arm Description
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.
Arm Title
Mental health education group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Self-administered acupressure group
Intervention Description
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
Intervention Name(s)
Mental health education group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient Health Questionnaire (PHQ)
Description
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.
Time Frame
It will be measured at baseline
Title
Patient Health Questionnaire (PHQ)
Description
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.
Time Frame
It will be measured at week 4 from baseline
Title
Patient Health Questionnaire (PHQ)
Description
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.
Time Frame
It will be measured at week 8 from baseline
Title
Patient Health Questionnaire (PHQ)
Description
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.
Time Frame
It will be measured at week 12 from baseline
Secondary Outcome Measure Information:
Title
Hamilton Depression Rating Scale (HDRS)
Description
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.
Time Frame
It will be measured at baseline
Title
Hamilton Depression Rating Scale (HDRS)
Description
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.
Time Frame
It will be measured at week 4 from baseline
Title
Hamilton Depression Rating Scale (HDRS)
Description
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.
Time Frame
It will be measured at week 8 from baseline
Title
Hamilton Depression Rating Scale (HDRS)
Description
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.
Time Frame
It will be measured at week 12 from baseline
Title
The Depression Anxiety Stress Scales (DASS-21) - Stress
Description
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).
Time Frame
It will be measured at baseline
Title
The Depression Anxiety Stress Scales (DASS-21) - Stress
Description
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).
Time Frame
It will be measured at week 4 from baseline
Title
The Depression Anxiety Stress Scales (DASS-21) - Stress
Description
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).
Time Frame
It will be measured at week 8 from baseline
Title
The Depression Anxiety Stress Scales (DASS-21) - Stress
Description
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).
Time Frame
It will be measured at week 12 from baseline
Title
The Depression Anxiety Stress Scales (DASS-21) - Anxiety
Description
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).
Time Frame
It will be measured at baseline
Title
The Depression Anxiety Stress Scales (DASS-21) - Anxiety
Description
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).
Time Frame
It will be measured at week 4 from baseline
Title
The Depression Anxiety Stress Scales (DASS-21) - Anxiety
Description
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).
Time Frame
It will be measured at week 8 from baseline
Title
The Depression Anxiety Stress Scales (DASS-21) - Anxiety
Description
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).
Time Frame
It will be measured at week 12 from baseline
Title
The Insomnia Severity Index (ISI)
Description
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.
Time Frame
It will be measured at baseline
Title
The Insomnia Severity Index (ISI)
Description
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.
Time Frame
It will be measured at week 4 from baseline
Title
The Insomnia Severity Index (ISI)
Description
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.
Time Frame
It will be measured at week 8 from baseline
Title
The Insomnia Severity Index (ISI)
Description
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.
Time Frame
It will be measured at week 12 from baseline
Title
The Short-Form (six-dimension) Health Survey (SF-6D)
Description
The SF-6D covers six domains using a scale of 1 to 6 to evaluate participants' general health and quality of life.
Time Frame
It will be measured at baseline
Title
The Short-Form (six-dimension) Health Survey (SF-6D)
Description
The SF-6D covers six domains using a scale of 1 to 6 to evaluate participants' general health and quality of life.
Time Frame
It will be measured at week 4 from baseline
Title
The Short-Form (six-dimension) Health Survey (SF-6D)
Description
The SF-6D covers six domains using a scale of 1 to 6 to evaluate participants' general health and quality of life.
Time Frame
It will be measured at week 8 from baseline
Title
The Short-Form (six-dimension) Health Survey (SF-6D)
Description
The SF-6D covers six domains using a scale of 1 to 6 to evaluate participants' general health and quality of life.
Time Frame
It will be measured at week 12 from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wing Fai Yeung, PhD
Phone
852 2766 4151
Email
jerry-wf.yeung@polyu.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wing Fai Yeung, PhD
Organizational Affiliation
the School of Nursing, the Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Nursing, the Hong Kong Polytechnic University
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
34623754
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.
Results Reference
background
PubMed Identifier
32147048
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.
Results Reference
background
PubMed Identifier
32096884
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.
Results Reference
background
PubMed Identifier
22231681
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.
Results Reference
background

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Self-administered Acupressure for Depression

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