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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05936905
Recruitment Status : Enrolling by invitation
First Posted : July 10, 2023
Last Update Posted : July 10, 2023
Sponsor:
Information provided by (Responsible Party):
Robert Hoffman, Yo San University of Traditional Chinese Medicine

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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).
Estimated Study Start Date : July 6, 2023
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : February 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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.

  2. 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. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • single intervention only

Exclusion Criteria:

  • chiropractic and acupuncture together
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05936905


Locations
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United States, California
Yo San University
Los Angeles, California, United States, 90066
Sponsors and Collaborators
Yo San University of Traditional Chinese Medicine
More Information
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Responsible Party: Robert Hoffman, CEO/DEAN, Yo San University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT05936905    
Other Study ID Numbers: YSU8232022
First Posted: July 10, 2023    Key Record Dates
Last Update Posted: July 10, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Robert Hoffman, Yo San University of Traditional Chinese Medicine:
Anxiety and depression
People living with HIV/AIDS (PLWH/A)
Acupuncture
Chiropractor
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Depression
Depressive Disorder
Anxiety Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders
Blood-Borne Infections
Communicable Diseases
Infections
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Slow Virus Diseases
Genital Diseases
Urogenital Diseases
Immunologic Deficiency Syndromes
Immune System Diseases