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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05936905
Other study ID # YSU8232022
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date July 6, 2023
Est. completion date February 1, 2024

Study information

Verified date July 2023
Source Yo San University of Traditional Chinese Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 30
Est. completion date February 1, 2024
Est. primary completion date December 1, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - single intervention only Exclusion Criteria: - chiropractic and acupuncture together

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Acupuncture
Acupuncture 1 time per month
Chiropractic
Chiropractic 1 time per month

Locations

Country Name City State
United States Yo San University Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
Yo San University of Traditional Chinese Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hospital Anxiety and Depression Scale (HADS) 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. 3 months
Primary The Patient Health Questionnaire 9-item (PHQ-9) 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. 3 months
Primary Generalized Anxiety Disorder 7-item (GAD-7) 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. 3 months
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