Acupuncture Therapy VS Chiropractor Group Therapy to Reduce Anxiety and Depression.

Sponsor

Yo San University of Traditional Chinese Medicine (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05936905

Collaborator

(none)

Enrollment

Location

Arms

6.9

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to determine and compare acupuncture therapy and chiropractor group therapy to reduce anxiety and depression among HIV/AIDS patients at Being Alive, Los Angeles. In this controlled clinical trial, a total of 30 patients will be divided into two groups, 15 in the acupuncture therapy group, 15 in the chiropractor group therapy. The Hospital Anxiety and Depression Scale (HADS), The Patient Health Questionnaire 9-item (PHQ-9) and Generalized Anxiety Disorder 7- item scales (GAD-7) will be used as screening tools for depressive and anxiety symptoms respectively.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Depression HIV/AIDS	Other: Acupuncture Other: Chiropractic	N/A

Detailed Description

In this study, the objectives are to determine and compare the prevalence of symptoms of depression and anxiety and find the most effective treatment method to assist patients in improving their quality of life utilizing holistic health treatments such as acupuncture and chiropractic to support their physical and mental health. Depression and anxiety are currently a major public health challenge worldwide especially during the Covid-19 pandemic. Approximately 280 million people within the world have depression, and over 700,000 people die due to suicide per annum (WHO, 2021). This depression and anxiety in PLWHAs can result in poor quality of life, and quality of work, school, and family life. Also, risky sexual behavior, the spreading of the virus, and at its worst, depression can result in suicide.

This controlled clinical trial will explore the treatment of acupuncture versus chiropractor care to seek out which treatment can help people living with HIV/AIDS (PLWH/A) to reduce depression and anxiety among PLWH/A patients in Being Alive, Los Angeles.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Staff members will administer the HADS, PHQ-9 and GAD-7 through a questionnaire. The scale is being administered to a convenience sample of 30 HIV/AIDs patients, divided into 15 samples of acupuncture treatment and 15 samples of chiropractor treatment, duration 3 months. Patients will complete questionnaire before and at the end of the treatments. Data to be collected includes socio-demographic. Symptoms of anxiety and depression are measured using the Hospital Anxiety and Depression Scale (HADS). The items are rated on 0, 1, 2, and 3 giving scores with minimum scores of 0 to 21. Scores on anxiety or depression subscales ranging from 0-7 are considered normal; 8-10 are considered cause for concern, borderline abnormal, and 11-21 are considered abnormal probable cases of anxiety or depression. The Patient Health Questionnaire 9-item(PHQ-9) if (score ≥9) significant mild depressive symptom and Generalized Anxiety Disorder 7-item (GAD-7) scale, if (score 8+) probable anxiety disorder.Staff members will administer the HADS, PHQ-9 and GAD-7 through a questionnaire. The scale is being administered to a convenience sample of 30 HIV/AIDs patients, divided into 15 samples of acupuncture treatment and 15 samples of chiropractor treatment, duration 3 months. Patients will complete questionnaire before and at the end of the treatments. Data to be collected includes socio-demographic. Symptoms of anxiety and depression are measured using the Hospital Anxiety and Depression Scale (HADS). The items are rated on 0, 1, 2, and 3 giving scores with minimum scores of 0 to 21. Scores on anxiety or depression subscales ranging from 0-7 are considered normal; 8-10 are considered cause for concern, borderline abnormal, and 11-21 are considered abnormal probable cases of anxiety or depression. The Patient Health Questionnaire 9-item(PHQ-9) if (score ≥9) significant mild depressive symptom and Generalized Anxiety Disorder 7-item (GAD-7) scale, if (score 8+) probable anxiety disorder.

Masking:

Double (Care Provider, Investigator)

Masking Description:

Single blind non randomized clinical trial.

Primary Purpose:

Treatment

Official Title:

A Controlled Clinical Trial of Group Acupuncture Therapy VS Chiropractor Group Therapy to Reduce Anxiety and Depression in People Living With HIV/AIDS (PLWH/A).

Anticipated Study Start Date :

Jul 6, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Acupuncture therapy This study aims to compare acupuncture therapy administered one time per month	Other: Acupuncture Acupuncture 1 time per month
Experimental: Chiropractor therapy This study aims to compare chiropractic therapy administered one time per month	Other: Chiropractic Chiropractic 1 time per month

Arm

Intervention/Treatment

Experimental: Acupuncture therapy

This study aims to compare acupuncture therapy administered one time per month

Other: Acupuncture

Acupuncture 1 time per month

Experimental: Chiropractor therapy

This study aims to compare chiropractic therapy administered one time per month

Other: Chiropractic

Chiropractic 1 time per month

Outcome Measures

Primary Outcome Measures

Hospital Anxiety and Depression Scale (HADS) [3 months]
Seven item questionnaire of each anxiety and depression. The items are rated on 0, 1, 2, and 3 giving scores with minimum scores of 0 to 21 maximum. Score interpretation on anxiety or depression subscales ranging from 0-7 considered non case, 8-10 considered possible case, and 11-21 considered probable case, which have been reclassified and relabeled as follows: 0-7 normal, 8-10 = mild, 11-15= moderate, and ≥16 = severe of anxiety or depression.
The Patient Health Questionnaire 9-item (PHQ-9) [3 months]
Patient Health Questionnaire for depression, score interpretation. Severity. The developers report the following interpretive guidelines for the PHQ-9 as a severity measure: 1-4 no depression, 5-9 = mild de- pression, 10-14= moderate depression, 15-19 = moderately severe depression, and 20-27= severe depression.
Generalized Anxiety Disorder 7-item (GAD-7) [3 months]
Anxiety Disorder 7-item, scoring Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate, and severe anxiety, respectively.