Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-03-02 @ 4:00 PM
Study NCT ID:
NCT05936905
Status:
COMPLETED
Last Update Posted:
2025-07-14
First Post:
2023-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acupuncture Therapy VS Chiropractor Group Therapy to Reduce Anxiety and Depression.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}, {'id': 'D026882', 'term': 'Manipulation, Chiropractic'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Single blind non randomized clinical trial.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-08', 'studyFirstSubmitDate': '2023-06-22', 'studyFirstSubmitQcDate': '2023-07-06', 'lastUpdatePostDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': '3 months', '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.'}, {'measure': 'The Patient Health Questionnaire 9-item (PHQ-9)', 'timeFrame': '3 months', '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.'}, {'measure': 'Generalized Anxiety Disorder 7-item (GAD-7)', 'timeFrame': '3 months', '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anxiety and depression', 'People living with HIV/AIDS (PLWH/A)', 'Acupuncture', 'Chiropractor'], 'conditions': ['Anxiety Depression', 'HIV/AIDS']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* single intervention only\n\nExclusion Criteria:\n\n* chiropractic and acupuncture together'}, 'identificationModule': {'nctId': 'NCT05936905', 'briefTitle': 'Acupuncture Therapy VS Chiropractor Group Therapy to Reduce Anxiety and Depression.', 'organization': {'class': 'OTHER', 'fullName': 'Yo San University of Traditional Chinese Medicine'}, 'officialTitle': '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).', 'orgStudyIdInfo': {'id': 'YSU8232022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acupuncture therapy', 'description': 'This study aims to compare acupuncture therapy administered one time per month', 'interventionNames': ['Other: Acupuncture']}, {'type': 'EXPERIMENTAL', 'label': 'Chiropractor therapy', 'description': 'This study aims to compare chiropractic therapy administered one time per month', 'interventionNames': ['Other: Chiropractic']}], 'interventions': [{'name': 'Acupuncture', 'type': 'OTHER', 'description': 'Acupuncture 1 time per month', 'armGroupLabels': ['Acupuncture therapy']}, {'name': 'Chiropractic', 'type': 'OTHER', 'description': 'Chiropractic 1 time per month', 'armGroupLabels': ['Chiropractor therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90066', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Yo San University', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yo San University of Traditional Chinese Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'CEO/DEAN', 'investigatorFullName': 'Robert Hoffman', 'investigatorAffiliation': 'Yo San University of Traditional Chinese Medicine'}}}}