Anxiety DepressionNCT05936905
Acupuncture Therapy VS Chiropractor Group Therapy to Reduce Anxiety and Depression.
A study testing Acupuncture and Chiropractic in people with Anxiety Depression and HIV/AIDS, run by Yo San University of Traditional Chinese Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anxiety Depression, HIV/AIDS
- What is being tested?
- Acupuncture and Chiropractic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2022to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- single intervention only
Who cannot join
- chiropractic and acupuncture together
Trial locations and contacts
1 site in 1 country.
About this study
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).
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.
Read the 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.
- Conditions
- Anxiety Depression, HIV/AIDS
- Being tested
- Acupuncture, Chiropractic
- Keywords
- Anxiety and depression, People living with HIV/AIDS (PLWH/A), Acupuncture, Chiropractor
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Acupuncture 1 time per month
ChiropracticOther
Chiropractic 1 time per month
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture therapy | Experimental | This study aims to compare acupuncture therapy administered one time per month Receives: Other: Acupuncture |
| Chiropractor therapy | Experimental | This study aims to compare chiropractic therapy administered one time per month Receives: Other: Chiropractic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start6 Dec 2022
- Primary completion1 Mar 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yo San University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Hoffman, Yo San University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05936905
- Sponsor's protocol ID
- YSU8232022
- Status last verified
- Jul 2025
- First submitted
- 22 Jun 2023
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT05936905
- Acronym / sponsor ID
- YSU8232022
- Conditions
- Anxiety Depression, HIV/AIDS
- Keywords
- Anxiety and depression, People living with HIV/AIDS (PLWH/A), Acupuncture, Chiropractor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Yo San University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 6 Dec 2022 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 10 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Acupuncture therapy | Experimental | Other: AcupunctureThis study aims to compare acupuncture therapy administered one time per month |
| Chiropractor therapy | Experimental | Other: ChiropracticThis study aims to compare chiropractic therapy administered one time per month |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- single intervention only
Key exclusion criteria (1 listed)
- chiropractic and acupuncture together
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureAcupuncture 1 time per month | Other | Acupuncture therapy |
| ChiropracticChiropractic 1 time per month | Other | Chiropractor therapy |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and Chiropractic in people with Anxiety Depression and HIV/AIDS, run by Yo San University of Traditional Chinese Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Anxiety and Depression Scale (HADS) (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025; AzTrials last refreshed its copy on 7 Nov 2026.