Self-administered Acupressure for Depression

Depression Clinical Trial

— SAAFD  

Official title:

Self-administered Acupressure for Depression: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05631184
• Other study ID #: SelfAcupDep
• Secondary ID: 19200171
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: The Hong Kong Polytechnic University
• Contact: Wing Fai Yeung, PhD
• Phone: 852 2766 4151
• Email: jerry-wf.yeung[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Symptoms

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
Hong Kong	School of Nursing, the Hong Kong Polytechnic University	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	Health and Medical Research Fund

Country where clinical trial is conducted

Hong Kong, 

References & Publications (4)

Cheung DST, Tiwari A, Yeung WF, Yu DSF, So MKP, Chau PH, Wang XM, Lum TYS, Yuk Fung HYK, Ng BYM, Zhang ZJ, Lao L. Self-Administered Acupressure for Caregivers of Older Family Members: A Randomized Controlled Trial. J Am Geriatr Soc. 2020 Jun;68(6):1193-1201. doi: 10.1111/jgs.16357. Epub 2020 Feb 25. — View Citation

Fernandez-Chinguel JE, Goicochea-Lugo S, Villarreal-Zegarra D, Taype-Rondan A, Zafra-Tanaka JH. Acupuncture for major depressive disorder: A review of the recommendations stated at clinical practice guidelines. Complement Ther Med. 2020 Mar;49:102321. doi: 10.1016/j.ctim.2020.102321. Epub 2020 Jan 24. — View Citation

Kroenke K. Enhancing the clinical utility of depression screening. CMAJ. 2012 Feb 21;184(3):281-2. doi: 10.1503/cmaj.112004. Epub 2012 Jan 9. No abstract available. — View Citation

Zhang Z, Li S, Meng H, Wang Y, Zhang Y, Wu M, Chen Y, Rong P, Wang Y. Efficacy and safety of acupuncture in the treatment of depression: A systematic review of clinical research. Anat Rec (Hoboken). 2021 Nov;304(11):2436-2453. doi: 10.1002/ar.24783. Epub 2021 Oct 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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