우울증 자가 관리 지압 (SAAFD)
우울증 자가 관리 지압: 무작위 대조 시험
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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 장소
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-
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Hong Kong, 홍콩
- School of Nursing, the Hong Kong Polytechnic University
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: 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. |
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. |
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활성 비교기: 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. |
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. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Patient Health Questionnaire (PHQ)
기간: It will be measured at baseline
|
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)
기간: It will be measured at week 4 from baseline
|
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)
기간: It will be measured at week 8 from baseline
|
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)
기간: It will be measured at week 12 from baseline
|
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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Hamilton Depression Rating Scale (HDRS)
기간: It will be measured at baseline
|
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)
기간: It will be measured at week 4 from baseline
|
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)
기간: It will be measured at week 8 from baseline
|
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)
기간: It will be measured at week 12 from baseline
|
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
기간: It will be measured at baseline
|
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
기간: It will be measured at week 4 from baseline
|
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
기간: It will be measured at week 8 from baseline
|
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
기간: It will be measured at week 12 from baseline
|
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
기간: It will be measured at baseline
|
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
기간: It will be measured at week 4 from baseline
|
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
기간: It will be measured at week 8 from baseline
|
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
기간: It will be measured at week 12 from baseline
|
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)
기간: It will be measured at baseline
|
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)
기간: It will be measured at week 4 from baseline
|
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)
기간: It will be measured at week 8 from baseline
|
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)
기간: It will be measured at week 12 from baseline
|
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)
기간: It will be measured at baseline
|
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)
기간: It will be measured at week 4 from baseline
|
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)
기간: It will be measured at week 8 from baseline
|
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)
기간: It will be measured at week 12 from baseline
|
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
|
공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: Wing Fai Yeung, PhD, the School of Nursing, the Hong Kong Polytechnic University
간행물 및 유용한 링크
일반 간행물
- 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.
- Yeung WF, Yu BYM, Ho FY, Wong CKH, Chung KF, Ruan JY, Chen S, Cheung DST, Zhang ZJ, Zick S, Cheng H, Ho YS, Ho LM, Lao L. Self-administered acupressure training for depression in community-dwelling individuals: a randomized controlled trial and cost-effectiveness analysis. EClinicalMedicine. 2026 Jun 16;96:104023. doi: 10.1016/j.eclinm.2026.104023. eCollection 2026 Jun.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- SelfAcupDep
- 19200171 (기타 보조금/기금 번호: Health and Medical Research Fund)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
The individual participant data will be available when the study has been published. The individual participant data will be available upon request.
IPD 공유 기간
No time restriction for the data availability.
IPD 공유 액세스 기준
The individual participant data will be available upon request.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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