Internet-based Video-conferencing to Address Alcohol Use and Pain: a Pilot Trial
Internet-based Videoconferencing to Address Alcohol Use and Pain Among People With HIV
2 other identifiers
interventional
49
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2020
Typical duration for not_applicable
2 active sites
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
First Submitted
Initial submission to the registry
June 18, 2020
CompletedFirst Posted
Study publicly available on registry
June 22, 2020
CompletedStudy Start
First participant enrolled
December 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 2, 2024
CompletedMarch 13, 2024
March 1, 2024
3.1 years
June 18, 2020
March 11, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
Alcohol Time Line Follow-Back (30)- Heavy Drinking Episodes
Number of heavy drinking episodes NIAAA criteria (5+drinks men/ 4+ drinks women)
Past 30 days
Alcohol Time Line Follow-Back (30) - Average Drinks per Week
Average number of standard alcohol-containing drinks in the past 30 days
Past 30 days
Brief Pain Inventory - Pain Severity
BPI is an 11-point scale anchored with "0" best and "10" is worst Scale range 0-10
Past 7 days
Brief Pain Inventory - Pain Interference
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
Past 7-Days
Secondary Outcomes (3)
Short Inventory of Alcohol Problems-Revised
3 months
Goal Systems Assessment Battery-Alcohol
Past 30 days
Goal Systems Assessment Battery-Pain
Past 30 days
Study Arms (2)
Intervention
EXPERIMENTALVideoconferencing Intervention for Heavy Drinking and Chronic Pain
Control
ACTIVE COMPARATORTreatment as Usual
Interventions
Videoconferencing intervention to reduce alcohol use and chronic pain interference and severity
Psychoeducation and Information about Treatment Resources
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- psychoactive medication for pain or alcohol use for fewer than 2 months
- history of bipolar disorder or schizophrenia
- current expressed suicidal intent
- prior history of alcohol withdrawal related seizures or delirium tremens
- current behavioral treatment for pain or alcohol use
- any scheduled surgery within the next 6 months or acute life threatening illness that requires treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Boston University Department of Psychological and Brain Sciences
Boston, Massachusetts, 02215, United States
General Clinical Research Unit, Boston University
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Three and six month assessments will be conducted by RA who is masked to intervention condition
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2020
First Posted
June 22, 2020
Study Start
December 23, 2020
Primary Completion
February 2, 2024
Study Completion
February 2, 2024
Last Updated
March 13, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- 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
- Access Criteria
- 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).
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.