Self-administered Acupressure for Depression

Study Overview
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Brief Summary
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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.

Official Title
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Self-administered Acupressure for Depression: A Randomized Controlled Trial

Conditions
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Depressive Symptoms, Depressive Disorder, Depression

Intervention / Treatment
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* Behavioral: Self-administered acupressure group
* Behavioral: Mental health education group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two-arm parallel assignment involves two groups of participants. In this study, one group will receive self-administered acupressure, and the other group will receive the mental health education. So during the trial, participants in one group receive self-administered acupressure in parallel to participants in the other group, who receive the mental health education.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-administered acupressure group<br>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. | Behavioral: Self-administered acupressure group<br>* 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.<br>|
| Active Comparator: Mental health education group<br>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. | Behavioral: Mental health education group<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire (PHQ) | 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) | 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) | 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) | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Rating Scale (HDRS) | 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) | 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) | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Acupressure, Randomized Controlled Trial