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Acupressão auto-administrada para depressão (SAAFD)

21 de setembro de 2026 atualizado por: The Hong Kong Polytechnic University

Acupressão autoadministrada para depressão: um estudo controlado randomizado

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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

250

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 65 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Comportamental: 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.
Comparador Ativo: 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.
Comportamental: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Patient Health Questionnaire (PHQ)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Hamilton Depression Rating Scale (HDRS)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

The Hong Kong Polytechnic University

Colaboradores

Health and Medical Research Fund

Investigadores

  • Investigador principal: Wing Fai Yeung, PhD, the School of Nursing, the Hong Kong Polytechnic University

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

20 de novembro de 2022

Conclusão Primária (Real)

19 de agosto de 2024

Conclusão do estudo (Real)

1 de setembro de 2024

Datas de inscrição no estudo

Enviado pela primeira vez

14 de novembro de 2022

Enviado pela primeira vez que atendeu aos critérios de CQ

20 de novembro de 2022

Primeira postagem (Real)

30 de novembro de 2022

Atualizações de registro de estudo

Última Atualização Postada (Real)

22 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

21 de setembro de 2026

Última verificação

1 de fevereiro de 2024

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • SelfAcupDep
  • 19200171 (Número de outro subsídio/financiamento: Health and Medical Research Fund)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

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

Prazo de Compartilhamento de IPD

No time restriction for the data availability.

Critérios de acesso de compartilhamento IPD

The individual participant data will be available upon request.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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