Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Zelf toegediende acupressuur voor depressie (SAAFD)

21 september 2026 bijgewerkt door: The Hong Kong Polytechnic University

Zelf-toegediende acupressuur voor depressie: een gerandomiseerde gecontroleerde studie

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

250

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: 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.
Actieve vergelijker: 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.
Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Patient Health Questionnaire (PHQ)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Hamilton Depression Rating Scale (HDRS)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

The Hong Kong Polytechnic University

Medewerkers

Health and Medical Research Fund

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

20 november 2022

Primaire voltooiing (Werkelijk)

19 augustus 2024

Studie voltooiing (Werkelijk)

1 september 2024

Studieregistratiedata

Eerst ingediend

14 november 2022

Eerst ingediend dat voldeed aan de QC-criteria

20 november 2022

Eerst geplaatst (Werkelijk)

30 november 2022

Updates van studierecords

Laatste update geplaatst (Werkelijk)

22 september 2026

Laatste update ingediend die voldeed aan QC-criteria

21 september 2026

Laatst geverifieerd

1 februari 2024

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • SelfAcupDep
  • 19200171 (Ander subsidie-/financieringsnummer: Health and Medical Research Fund)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

IPD-tijdsbestek voor delen

No time restriction for the data availability.

IPD-toegangscriteria voor delen

The individual participant data will be available upon request.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren