うつ病のための自己管理指圧 (SAAFD)
うつ病のための自己管理指圧：ランダム化比較試験
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.
調査の概要
状態
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Hong Kong、香港
- School of Nursing, the Hong Kong Polytechnic University
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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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アクティブコンパレータ：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Patient Health Questionnaire (PHQ)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Hamilton Depression Rating Scale (HDRS)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
|
協力者と研究者
捜査官
- 主任研究者：Wing Fai Yeung, PhD、the School of Nursing, the Hong Kong Polytechnic University
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- SelfAcupDep
- 19200171 (その他の助成金/資金番号：Health and Medical Research Fund)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
The individual participant data will be available when the study has been published. The individual participant data will be available upon request.
IPD 共有時間枠
No time restriction for the data availability.
IPD 共有アクセス基準
The individual participant data will be available upon request.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
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