Internet-based Video-conferencing to Address Alcohol Use and Pain: a Pilot Trial

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.

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

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

17-item measure with 4-point Likert scale items ranging from "0" never to "3" daily/almost daily. Scale range 0-51

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

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

Inclusion Criteria: 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 Exclusion Criteria: 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

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.

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

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).