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

Primary Purpose

Anxiety Depression, HIV/AIDS

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Chiropractic
Sponsored by
Yo San University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Depression focused on measuring Anxiety and depression, People living with HIV/AIDS (PLWH/A), Acupuncture, Chiropractor

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: single intervention only Exclusion Criteria: chiropractic and acupuncture together

Sites / Locations

  • Yo San University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Acupuncture therapy

Chiropractor therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 22, 2023
Last Updated
July 6, 2023
Sponsor
Yo San University of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05936905
Brief Title
Acupuncture Therapy VS Chiropractor Group Therapy to Reduce Anxiety and Depression.
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).
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 6, 2023 (Anticipated)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yo San University of Traditional Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Depression, HIV/AIDS
Keywords
Anxiety and depression, People living with HIV/AIDS (PLWH/A), Acupuncture, Chiropractor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Care ProviderInvestigator
Masking Description
Single blind non randomized clinical trial.
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture therapy
Arm Type
Experimental
Arm Description
This study aims to compare acupuncture therapy administered one time per month
Arm Title
Chiropractor therapy
Arm Type
Experimental
Arm Description
This study aims to compare chiropractic therapy administered one time per month
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
Acupuncture 1 time per month
Intervention Type
Other
Intervention Name(s)
Chiropractic
Intervention Description
Chiropractic 1 time per month
Primary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
3 months
Title
The Patient Health Questionnaire 9-item (PHQ-9)
Description
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.
Time Frame
3 months
Title
Generalized Anxiety Disorder 7-item (GAD-7)
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: single intervention only Exclusion Criteria: chiropractic and acupuncture together
Facility Information:
Facility Name
Yo San University
City
Los Angeles
State/Province
California
ZIP/Postal Code
90066
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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