Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-02-28 @ 10:37 PM
Study NCT ID:
NCT03149094
Status:
COMPLETED
Last Update Posted:
2018-07-18
First Post:
2017-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CBSM Intervention Via mHealth to Ameliorate HIV-related Fatigue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'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': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-17', 'studyFirstSubmitDate': '2017-05-04', 'studyFirstSubmitQcDate': '2017-05-09', 'lastUpdatePostDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility and Acceptability Scale', 'timeFrame': 'Baseline', 'description': 'The Feasibility and Acceptability Scale is a 5 item, 5-point scale, developed to assess the feasibility and acceptability of interventions.'}, {'measure': 'Feasibility and Acceptability Scale', 'timeFrame': '10 weeks', 'description': 'The Feasibility and Acceptability Scale is a 5 item, 5-point scale, developed to assess the feasibility and acceptability of interventions.'}, {'measure': 'Feasibility and Acceptability Scale', 'timeFrame': '22 weeks', 'description': 'The Feasibility and Acceptability Scale is a 5 item, 5-point scale, developed to assess the feasibility and acceptability of interventions.'}], 'secondaryOutcomes': [{'measure': 'HIV-Related Fatigue Scale (HRFS)', 'timeFrame': 'Baseline', 'description': 'The HRFS is a 56-item instrument which assesses fatigue severity, responsiveness to self-care, and fatigue-related impairment of functioning in HIV infection.'}, {'measure': 'HIV-Related Fatigue Scale (HRFS)', 'timeFrame': '5 weeks', 'description': 'The HRFS is a 56-item instrument which assesses fatigue severity, responsiveness to self-care, and fatigue-related impairment of functioning in HIV infection.'}, {'measure': 'HIV-Related Fatigue Scale (HRFS)', 'timeFrame': '10 weeks', 'description': 'The HRFS is a 56-item instrument which assesses fatigue severity, responsiveness to self-care, and fatigue-related impairment of functioning in HIV infection.'}, {'measure': 'HIV-Related Fatigue Scale (HRFS)', 'timeFrame': '22 weeks', 'description': 'The HRFS is a 56-item instrument which assesses fatigue severity, responsiveness to self-care, and fatigue-related impairment of functioning in HIV infection.'}, {'measure': 'PROMIS Short Form - Fatigue 8a', 'timeFrame': 'Baseline', 'description': "The PROMIS Fatigue 8a evaluates a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social role."}, {'measure': 'PROMIS Short Form - Fatigue 8a', 'timeFrame': '5 weeks', 'description': "The PROMIS Fatigue 8a evaluates a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social role."}, {'measure': 'PROMIS Short Form - Fatigue 8a', 'timeFrame': '10 weeks', 'description': "The PROMIS Fatigue 8a evaluates a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social role."}, {'measure': 'PROMIS Short Form - Fatigue 8a', 'timeFrame': '22 weeks', 'description': "The PROMIS Fatigue 8a evaluates a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social role."}, {'measure': 'The State Trait Anxiety Inventory (STAI)-State', 'timeFrame': 'Baseline', 'description': 'The STAI is a self-report measure of state anxiety, consisting of 20 emotion descriptor items; respondents indicate how they are feeling right now by rating each item on a 4-point scale.'}, {'measure': 'The State Trait Anxiety Inventory (STAI)-State', 'timeFrame': '5 weeks', 'description': 'The STAI is a self-report measure of state anxiety, consisting of 20 emotion descriptor items; respondents indicate how they are feeling right now by rating each item on a 4-point scale.'}, {'measure': 'The State Trait Anxiety Inventory (STAI)-State', 'timeFrame': '10 weeks', 'description': 'The STAI is a self-report measure of state anxiety, consisting of 20 emotion descriptor items; respondents indicate how they are feeling right now by rating each item on a 4-point scale.'}, {'measure': 'The State Trait Anxiety Inventory (STAI)-State', 'timeFrame': '22 weeks', 'description': 'The STAI is a self-report measure of state anxiety, consisting of 20 emotion descriptor items; respondents indicate how they are feeling right now by rating each item on a 4-point scale.'}, {'measure': 'Beck Depression Inventory (BDI-II)', 'timeFrame': 'Baseline', 'description': 'The BDI-II is a 21 item measure of depressive severity with higher total scores indicative of more severe depression.'}, {'measure': 'Beck Depression Inventory (BDI-II)', 'timeFrame': '5 weeks', 'description': 'The BDI-II is a 21 item measure of depressive severity with higher total scores indicative of more severe depression.'}, {'measure': 'Beck Depression Inventory (BDI-II)', 'timeFrame': '10 weeks', 'description': 'The BDI-II is a 21 item measure of depressive severity with higher total scores indicative of more severe depression.'}, {'measure': 'Beck Depression Inventory (BDI-II)', 'timeFrame': '22 weeks', 'description': 'The BDI-II is a 21 item measure of depressive severity with higher total scores indicative of more severe depression.'}, {'measure': 'Life Experiences Scale', 'timeFrame': 'Baseline', 'description': 'The Life Experiences Scale is a 30-item self-report measure that allows respondents to indicate recent stressful life events.'}, {'measure': 'Life Experiences Scale', 'timeFrame': '5 weeks', 'description': 'The Life Experiences Scale is a 30-item self-report measure that allows respondents to indicate recent stressful life events.'}, {'measure': 'Life Experiences Scale', 'timeFrame': '10 weeks', 'description': 'The Life Experiences Scale is a 30-item self-report measure that allows respondents to indicate recent stressful life events.'}, {'measure': 'Life Experiences Scale', 'timeFrame': '22 weeks', 'description': 'The Life Experiences Scale is a 30-item self-report measure that allows respondents to indicate recent stressful life events.'}, {'measure': 'CD4 count from the medical record', 'timeFrame': 'Baseline', 'description': 'A CD4 count is a lab test that measures the number of CD4 T lymphocytes (CD4 cells) in a sample of blood. In people with HIV, it is the most important laboratory indicator of how well the immune system is working and the strongest predictor of HIV progression.'}, {'measure': 'CD4 count from the medical record', 'timeFrame': '22 weeks', 'description': 'A CD4 count is a lab test that measures the number of CD4 T lymphocytes (CD4 cells) in a sample of blood. In people with HIV, it is the most important laboratory indicator of how well the immune system is working and the strongest predictor of HIV progression.'}, {'measure': 'HIV viral load information from the medical record', 'timeFrame': 'Baseline', 'description': 'A viral load test is a lab test that measures the number of HIV virus particles in a milliliter of blood. A viral load test helps provide information on how well antiretroviral therapy is controlling the virus.'}, {'measure': 'HIV viral load information from the medical record', 'timeFrame': '22 weeks', 'description': 'A viral load test is a lab test that measures the number of HIV virus particles in a milliliter of blood. A viral load test helps provide information on how well antiretroviral therapy is controlling the virus.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Self-Management', 'mHealth'], 'conditions': ['HIV', 'Stress Disorder', 'Human Immunodeficiency Virus', 'Fatigue']}, 'referencesModule': {'references': [{'pmid': '31539601', 'type': 'DERIVED', 'citation': 'Barroso J, Madisetti M, Mueller M. A Feasibility Study to Develop and Test a Cognitive Behavioral Stress Management Mobile Health Application for HIV-Related Fatigue. J Pain Symptom Manage. 2020 Feb;59(2):242-253. doi: 10.1016/j.jpainsymman.2019.09.009. Epub 2019 Sep 17.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to create a smartphone, tablet and web-based application to help people deal with stress. Stress often increases fatigue in people with HIV infection, so successfully dealing with stress could help reduce HIV-related fatigue. The study is being done at one site, the Medical University of South Carolina. Approximately 30 people will take part in this portion of the study.', 'detailedDescription': 'For this study we will develop a fatigue symptom self-management cognitive behavioral stress management (CBSM) program that will be delivered via mHealth through smartphones and tablets (optimized for each). All CBSM content will be integrated into the application, but tailoring of information delivery will be derived through algorithm-driven feedback based on user input as they respond to integrated assessment and symptom monitoring questions. As a result, users of the CBSM-Self Management Intervention (CBSM-SMI) will receive personalized, relevant intervention content, when they need it, where they need it. This novel mode of CBSM delivery has not yet been provided via an mHealth format to HIV-infected individuals, despite its obvious advantages insofar as cost and reach are concerned.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV positive\n* Reads and understands English\n* Scores greater than 5 on the HIV-Related Fatigue Scale\n* Mentally competent to give informed consent\n\nExclusion Criteria:\n\n* Co-morbid conditions marked by fatigue (e.g., renal disease, cancer, multiple sclerosis)\n* Pregnant women and women who are less than 1 year postpartum\n* Active psychosis or dementia\n* Suicidal ideation with clear intent\n* Current substance dependence'}, 'identificationModule': {'nctId': 'NCT03149094', 'briefTitle': 'CBSM Intervention Via mHealth to Ameliorate HIV-related Fatigue', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'Feasibility and Acceptability of an mHealth Cognitive Behavioral Stress Management Intervention to Ameliorate HIV-related Fatigue', 'orgStudyIdInfo': {'id': 'Pro00057504'}, 'secondaryIdInfos': [{'id': '1P20NR016575-01', 'link': 'https://reporter.nih.gov/quickSearch/1P20NR016575-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CBSM-SMI', 'description': 'The intervention group will receive Cognitive Behavioral Stress Management (CBSM) for Individuals Living with HIV via mHealth through smartphones and tablets.', 'interventionNames': ['Behavioral: CBSM-SMI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CBSM-SMI control', 'description': 'The control group will receive an app called LifeSum, which focuses on healthy lifestyles.', 'interventionNames': ['Behavioral: CBSM-SMI control']}], 'interventions': [{'name': 'CBSM-SMI', 'type': 'BEHAVIORAL', 'description': 'The intervention group will receive Cognitive Behavioral Stress Management (CBSM) for Individuals Living with HIV via mHealth through smartphones and tablets.', 'armGroupLabels': ['CBSM-SMI']}, {'name': 'CBSM-SMI control', 'type': 'BEHAVIORAL', 'description': 'this group will receive the LifeSum app.', 'armGroupLabels': ['CBSM-SMI control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}