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Digitopressione autosomministrata per la depressione (SAAFD)

21 settembre 2026 aggiornato da: The Hong Kong Polytechnic University

Digitopressione autosomministrata per la depressione: uno studio controllato randomizzato

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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

250

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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.
Comparatore attivo: 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.
Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Patient Health Questionnaire (PHQ)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Hamilton Depression Rating Scale (HDRS)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

The Hong Kong Polytechnic University

Collaboratori

Health and Medical Research Fund

Investigatori

  • Investigatore principale: Wing Fai Yeung, PhD, the School of Nursing, the Hong Kong Polytechnic University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

20 novembre 2022

Completamento primario (Effettivo)

19 agosto 2024

Completamento dello studio (Effettivo)

1 settembre 2024

Date di iscrizione allo studio

Primo inviato

14 novembre 2022

Primo inviato che soddisfa i criteri di controllo qualità

20 novembre 2022

Primo Inserito (Effettivo)

30 novembre 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 settembre 2026

Ultimo verificato

1 febbraio 2024

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • SelfAcupDep
  • 19200171 (Altro numero di sovvenzione/finanziamento: Health and Medical Research Fund)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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

Periodo di condivisione IPD

No time restriction for the data availability.

Criteri di accesso alla condivisione IPD

The individual participant data will be available upon request.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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