Self-administered Acupressure for Depression

Not Applicable

Recruiting

• Conditions: Depressive Disorder; Depressive Symptoms; Depression
• Interventions: Behavioral: Self-administered acupressure group; Behavioral: Mental health education group

• Registration Number: NCT05631184
• Lead Sponsor: The Hong Kong Polytechnic University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-14
• Study First Submitted QC: 2022-11-20
• Study First Posted: 2022-11-30
• Study Start: 2022-12-15
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-28
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-administered acupressure group	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.
Mental health education group	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.

Primary Outcome Measures

Name	Time	Method
Patient Health Questionnaire (PHQ)	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 Outcome Measures

Name	Time	Method
The Short-Form (six-dimension) Health Survey (SF-6D)	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.
The Depression Anxiety Stress Scales (DASS-21) - Stress	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).
The Insomnia Severity Index (ISI)	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.
Hamilton Depression Rating Scale (HDRS)	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.
The Depression Anxiety Stress Scales (DASS-21) - Anxiety	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).

Trial Locations

Locations (1)

School of Nursing, the Hong Kong Polytechnic University; 🇭🇰 Hong Kong, Hong Kong