NCT05936905

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 6, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 10, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

July 14, 2025

Status Verified

July 1, 2025

Enrollment Period

1.2 years

First QC Date

June 22, 2023

Last Update Submit

July 8, 2025

Conditions

Keywords

Anxiety and depressionPeople living with HIV/AIDS (PLWH/A)AcupunctureChiropractor

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

Acupuncture therapy

EXPERIMENTAL

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

Other: Acupuncture

Chiropractor therapy

EXPERIMENTAL

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

Other: Chiropractic

Interventions

Acupuncture 1 time per month

Acupuncture therapy

Chiropractic 1 time per month

Chiropractor therapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • single intervention only

You may not qualify if:

  • chiropractic and acupuncture together

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yo San University

Los Angeles, California, 90066, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeAnxiety DisordersDepression

Interventions

Acupuncture TherapyManipulation, Chiropractic

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsMusculoskeletal Manipulations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Masking Details
Single blind non randomized clinical trial.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
CEO/DEAN

Study Record Dates

First Submitted

June 22, 2023

First Posted

July 10, 2023

Study Start

December 6, 2022

Primary Completion

March 1, 2024

Study Completion

August 1, 2024

Last Updated

July 14, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations