- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05936905
Acupuncture Therapy VS Chiropractor Group Therapy to Reduce Anxiety and Depression.
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).
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90066
- Yo San University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- single intervention only
Exclusion Criteria:
- chiropractic and acupuncture together
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Acupuncture therapy
This study aims to compare acupuncture therapy administered one time per month
|
Acupuncture 1 time per month
|
|
Experimental: Chiropractor therapy
This study aims to compare chiropractic therapy administered one time per month
|
Chiropractic 1 time per month
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospital Anxiety and Depression Scale (HADS)
Time Frame: 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.
|
3 months
|
|
The Patient Health Questionnaire 9-item (PHQ-9)
Time Frame: 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.
|
3 months
|
|
Generalized Anxiety Disorder 7-item (GAD-7)
Time Frame: 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.
|
3 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Blood-Borne Infections
- Urogenital Diseases
- Genital Diseases
- Mental Disorders
- Immune System Diseases
- Behavioral Symptoms
- Infections
- RNA Virus Infections
- Virus Diseases
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Mood Disorders
- Slow Virus Diseases
- Anxiety Disorders
- HIV Infections
- Depression
- Depressive Disorder
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- YSU8232022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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