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| ID | Type | Description | Link |
|---|---|---|---|
| UH3AA026192 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Videoconferencing Intervention for Heavy Drinking and Chronic Pain |
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| Control | Active Comparator | Treatment as Usual |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivational and Cognitive-Behavioral Management for Alcohol and Pain (MCBMAP) | Behavioral | Videoconferencing intervention to reduce alcohol use and chronic pain interference and severity |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Short Inventory of Alcohol Problems-Revised | 17-item measure with 4-point Likert scale items ranging from "0" never to "3" daily/almost daily. Scale range 0-51 | 3 months |
| Goal Systems Assessment Battery-Alcohol |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston University Department of Psychological and Brain Sciences | Boston | Massachusetts | 02215 | United States | ||
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).
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Compare Intervention to Control Condition in a Between Subjects Design
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Three and six month assessments will be conducted by RA who is masked to intervention condition
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| Treatment as Usual | Behavioral | Psychoeducation and Information about Treatment Resources |
|
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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
| Past 30 days |
| Goal Systems Assessment Battery-Pain | 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 | Past 30 days |
| General Clinical Research Unit, Boston University |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| D008722 | Methods |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D008919 | Investigative Techniques |
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