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Samodzielna akupresura na depresję (SAAFD)

21 września 2026 zaktualizowane przez: The Hong Kong Polytechnic University

Samodzielna akupresura na depresję: randomizowana, kontrolowana próba

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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

250

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 65 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Behawioralne: 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.
Aktywny komparator: 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.
Behawioralne: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Patient Health Questionnaire (PHQ)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Hamilton Depression Rating Scale (HDRS)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

The Hong Kong Polytechnic University

Współpracownicy

Health and Medical Research Fund

Śledczy

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

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

20 listopada 2022

Zakończenie podstawowe (Rzeczywisty)

19 sierpnia 2024

Ukończenie studiów (Rzeczywisty)

1 września 2024

Daty rejestracji na studia

Pierwszy przesłany

14 listopada 2022

Pierwszy przesłany, który spełnia kryteria kontroli jakości

20 listopada 2022

Pierwszy wysłany (Rzeczywisty)

30 listopada 2022

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

22 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

21 września 2026

Ostatnia weryfikacja

1 lutego 2024

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • SelfAcupDep
  • 19200171 (Inny numer grantu/finansowania: Health and Medical Research Fund)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

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

Ramy czasowe udostępniania IPD

No time restriction for the data availability.

Kryteria dostępu do udostępniania IPD

The individual participant data will be available upon request.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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