Acupuncture Therapy VS Chiropractor Group Therapy to Reduce Anxiety and Depression.
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ClinicalTrials.gov Identifier: NCT05936905 |
Recruitment Status :
Enrolling by invitation
First Posted : July 10, 2023
Last Update Posted : July 10, 2023
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Condition or disease | Intervention/treatment | Phase |
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Anxiety Depression HIV/AIDS | Other: Acupuncture Other: Chiropractic | Not Applicable |
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 : | 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 |
Arm | Intervention/treatment |
---|---|
Experimental: Acupuncture therapy
This study aims to compare acupuncture therapy administered one time per month
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Other: Acupuncture
Acupuncture 1 time per month |
Experimental: Chiropractor therapy
This study aims to compare chiropractic therapy administered one time per month
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Other: Chiropractic
Chiropractic 1 time per month |
- 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.
- 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.
- 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.
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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- single intervention only
Exclusion Criteria:
- chiropractic and acupuncture together
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
United States, California | |
Yo San University | |
Los Angeles, California, United States, 90066 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Anxiety and depression People living with HIV/AIDS (PLWH/A) Acupuncture Chiropractor |
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 |