Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT04441593
Status:
COMPLETED
Last Update Posted:
2024-03-13
First Post:
2020-06-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Internet-based Video-conferencing to Address Alcohol Use and Pain: a Pilot Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000428', 'term': 'Alcohol Drinking'}], 'ancestors': [{'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000431', 'term': 'Ethanol'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D013812', 'term': 'Therapeutics'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Three and six month assessments will be conducted by RA who is masked to intervention condition'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Compare Intervention to Control Condition in a Between Subjects Design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-11', 'studyFirstSubmitDate': '2020-06-18', 'studyFirstSubmitQcDate': '2020-06-18', 'lastUpdatePostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alcohol Time Line Follow-Back (30)- Heavy Drinking Episodes', 'timeFrame': 'Past 30 days', 'description': 'Number of heavy drinking episodes NIAAA criteria (5+drinks men/ 4+ drinks women)'}, {'measure': 'Alcohol Time Line Follow-Back (30) - Average Drinks per Week', 'timeFrame': 'Past 30 days', 'description': 'Average number of standard alcohol-containing drinks in the past 30 days'}, {'measure': 'Brief Pain Inventory - Pain Severity', 'timeFrame': 'Past 7 days', 'description': 'BPI is an 11-point scale anchored with "0" best and "10" is worst Scale range 0-10'}, {'measure': 'Brief Pain Inventory - Pain Interference', 'timeFrame': 'Past 7-Days', 'description': 'BPI is an 11-point scale anchored with "0" best and "10" is worst Scale range 0-10. Pain Interference is measured as the mean of 7-items each rated on an 11-point scale'}], 'secondaryOutcomes': [{'measure': 'Short Inventory of Alcohol Problems-Revised', 'timeFrame': '3 months', 'description': '17-item measure with 4-point Likert scale items ranging from "0" never to "3" daily/almost daily. Scale range 0-51'}, {'measure': 'Goal Systems Assessment Battery-Alcohol', 'timeFrame': 'Past 30 days', 'description': 'Ratings of self-regulatory capacities related to reducing alcohol use. Items are 5-point Likert-scales. There are 4 subscales utilized including planning, monitoring, self-efficacy, and value. Higher scores indicate better outcomes'}, {'measure': 'Goal Systems Assessment Battery-Pain', 'timeFrame': 'Past 30 days', 'description': 'Ratings of self-regulatory capacities related to reducing alcohol use. Items are 5-point Likert-scales. There are 4 subscales utilized including planning, monitoring, self-efficacy, and value. Higher scores indicate better outcomes'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcohol Drinking and Chronic Pain Intervention', 'Control Condition']}, 'descriptionModule': {'briefSummary': 'This pilot study seeks to provide effect size estimates and test feasibility of a novel, integrated behavioral approach to reduce heavy drinking and chronic pain among patients in HIV-care delivered via internet-based videoconferencing.', 'detailedDescription': 'This pilot study is a between-groups design to compare a novel integrated behavioral video telehealth intervention for heavy drinking PLWH with chronic pain to a control condition. Forty-eight heavy drinking patients in HIV-care with moderate or greater pain will be recruited for the study. Following baseline assessment, participants will be randomly assigned to either intervention or control conditions. Participants will complete assessment measures of heavy drinking and pain interference/severity at 3 and 6 months post-baseline. Secondary alcohol outcomes will include alcohol-related consequences'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* engaged in HIV care, heavy drinking defined as more than 7/14 drinks per week for women/men or by a single episode of 4/5 (women/men), chronic (at least 3 months duration) moderate or greater (4 or more on the severity scale of the BPI, and non-cancer related pain\n\nExclusion Criteria:\n\n* psychoactive medication for pain or alcohol use for fewer than 2 months\n* history of bipolar disorder or schizophrenia\n* current expressed suicidal intent\n* prior history of alcohol withdrawal related seizures or delirium tremens\n* current behavioral treatment for pain or alcohol use\n* any scheduled surgery within the next 6 months or acute life threatening illness that requires treatment'}, 'identificationModule': {'nctId': 'NCT04441593', 'briefTitle': 'Internet-based Video-conferencing to Address Alcohol Use and Pain: a Pilot Trial', 'organization': {'class': 'OTHER', 'fullName': 'Boston University Charles River Campus'}, 'officialTitle': 'Internet-based Videoconferencing to Address Alcohol Use and Pain Among People With HIV', 'orgStudyIdInfo': {'id': '4546 [Study 3]'}, 'secondaryIdInfos': [{'id': 'UH3AA026192', 'link': 'https://reporter.nih.gov/quickSearch/UH3AA026192', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Videoconferencing Intervention for Heavy Drinking and Chronic Pain', 'interventionNames': ['Behavioral: Motivational and Cognitive-Behavioral Management for Alcohol and Pain (MCBMAP)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Treatment as Usual', 'interventionNames': ['Behavioral: Treatment as Usual']}], 'interventions': [{'name': 'Motivational and Cognitive-Behavioral Management for Alcohol and Pain (MCBMAP)', 'type': 'BEHAVIORAL', 'otherNames': ['Intervention'], 'description': 'Videoconferencing intervention to reduce alcohol use and chronic pain interference and severity', 'armGroupLabels': ['Intervention']}, {'name': 'Treatment as Usual', 'type': 'BEHAVIORAL', 'otherNames': ['Control'], 'description': 'Psychoeducation and Information about Treatment Resources', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston University Department of Psychological and Brain Sciences', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'General Clinical Research Unit, Boston University', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Twelve months following request, de-identified data will be available to investigators upon request. This access will be provided for 7 years following publication of main trial', 'ipdSharing': 'YES', 'description': 'For proposals that contain analyses that are not already planned or in progress, the investigators will make data available for collaboration with a study investigator, provided IRB and other appropriate regulatory approvals are obtained (including but not limited to Federal and Boston University IRB review and approval). Data to be shared will be de-identified to minimize the risk of deductive disclosure. Documentation will be provided for all shared data including copies of data collection forms, schedule of study assessments, data dictionaries documenting all original and derived variables, descriptive statistics for all variables included in the data sets, and a written description of the study conduct and noteworthy details anticipated to potentially affect data interpretation. Costs associated with producing data sets and analysis will be the responsibility of investigators seeking the data.', 'accessCriteria': 'Specific data may be shared based on proposals received and reviewed by the study investigators and determined to have scientific merit. Limited public-use data sets may also be prepared and made available in a web-data archive to be developed and maintained by the data coordinating center (BEDAC).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston University Charles River Campus', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}