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Самостоятельная акупрессура при депрессии (SAAFD)

21 сентября 2026 г. обновлено: The Hong Kong Polytechnic University

Самостоятельное применение акупрессуры при депрессии: рандомизированное контролируемое исследование

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.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

250

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

  • Гонконг
      • Hong Kong, Гонконг
        • School of Nursing, the Hong Kong Polytechnic University

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 18 лет до 65 лет (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Одинокий

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 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.
Поведенческий: 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.
Активный компаратор: 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.
Поведенческий: 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.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Patient Health Questionnaire (PHQ)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Hamilton Depression Rating Scale (HDRS)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

The Hong Kong Polytechnic University

Соавторы

Health and Medical Research Fund

Следователи

  • Главный следователь: Wing Fai Yeung, PhD, the School of Nursing, the Hong Kong Polytechnic University

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

20 ноября 2022 г.

Первичное завершение (Действительный)

19 августа 2024 г.

Завершение исследования (Действительный)

1 сентября 2024 г.

Даты регистрации исследования

Первый отправленный

14 ноября 2022 г.

Впервые представлено, что соответствует критериям контроля качества

20 ноября 2022 г.

Первый опубликованный (Действительный)

30 ноября 2022 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

22 сентября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

21 сентября 2026 г.

Последняя проверка

1 февраля 2024 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • SelfAcupDep
  • 19200171 (Другой номер гранта/финансирования: Health and Medical Research Fund)

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана IPD

The individual participant data will be available when the study has been published. The individual participant data will be available upon request.

Сроки обмена IPD

No time restriction for the data availability.

Критерии совместного доступа к IPD

The individual participant data will be available upon request.

Совместное использование IPD Поддерживающий тип информации

  • STUDY_PROTOCOL
  • САП

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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