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Completed

NCT Number: NCT05631184

Self-administered Acupressure for Depression

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.

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Key information

Conditions

Depressive Symptoms Behavior Behavioral Symptoms Depression Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Nursing, the Hong Kong Polytechnic University

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hong Kong residents aged 18 to 65
  • Can communicate in Cantonese and comprehend written Chinese
  • Have moderate or above-level depression as measured by the PHQ-9 with a score of 10 or above
  • Willing to give informed consent and comply with the trial protocol.

Exclusion criteria

  • Have the PHQ score of 20 or above (referral information to community psychological services will be provided)
  • New onset or change of antidepressant medication or dosage in the last 3 months
  • 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.
  • Have cognitive impairment diagnosed by the Hong Kong Montreal Cognitive Assessment with a score < 22
  • Skin lesions or infections at the treatment sites
  • Significant suicidal risk as rated by the Hamilton Depression Rating Scale item on suicide (score ≥3)
  • Pregnant or childbearing potential but not using adequate contraception
  • With any major medical condition that causes depression based on the judgement of a psychiatrist.

Treatment and study plan

Self-administered acupressure group

Behavioral

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.

Mental health education group

Behavioral

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.

Primary outcomes

  1. Patient Health Questionnaire (PHQ)

    Time frame: 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.

  2. Patient Health Questionnaire (PHQ)

    Time frame: 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.

  3. Patient Health Questionnaire (PHQ)

    Time frame: 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.

  4. Patient Health Questionnaire (PHQ)

    Time frame: 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.

Secondary outcomes

  1. Hamilton Depression Rating Scale (HDRS)

    Time frame: 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.

  2. Hamilton Depression Rating Scale (HDRS)

    Time frame: 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.

  3. Hamilton Depression Rating Scale (HDRS)

    Time frame: 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.

  4. Hamilton Depression Rating Scale (HDRS)

    Time frame: 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.

  5. The Depression Anxiety Stress Scales (DASS-21) - Stress

    Time frame: 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).

  6. The Depression Anxiety Stress Scales (DASS-21) - Stress

    Time frame: 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).

  7. The Depression Anxiety Stress Scales (DASS-21) - Stress

    Time frame: 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).

  8. The Depression Anxiety Stress Scales (DASS-21) - Stress

    Time frame: 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).

  9. The Depression Anxiety Stress Scales (DASS-21) - Anxiety

    Time frame: 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).

  10. The Depression Anxiety Stress Scales (DASS-21) - Anxiety

    Time frame: 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).

  11. The Depression Anxiety Stress Scales (DASS-21) - Anxiety

    Time frame: 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).

  12. The Depression Anxiety Stress Scales (DASS-21) - Anxiety

    Time frame: 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).

  13. The Insomnia Severity Index (ISI)

    Time frame: 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.

  14. The Insomnia Severity Index (ISI)

    Time frame: 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.

  15. The Insomnia Severity Index (ISI)

    Time frame: 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.

  16. The Insomnia Severity Index (ISI)

    Time frame: 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.

  17. The Short-Form (six-dimension) Health Survey (SF-6D)

    Time frame: 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.

  18. The Short-Form (six-dimension) Health Survey (SF-6D)

    Time frame: 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.

  19. The Short-Form (six-dimension) Health Survey (SF-6D)

    Time frame: 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.

  20. The Short-Form (six-dimension) Health Survey (SF-6D)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

  • Health and Medical Research Fund

Registry information

Official study title

Self-administered Acupressure for Depression: A Randomized Controlled Trial

Acronym: SAAFD

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 30, 2022
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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