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| ID | Type | Description | Link |
|---|---|---|---|
| UH2AA026192 | 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 research seeks to develop a novel, integrated behavioral approach to reduce heavy drinking and chronic pain among patients in HIV-care delivered via internet-based videoconferencing. This first open trial pilot study seeks to recruit patients in the clinic through posted flyers, cards and physician referral.
This study seeks to develop an integrated, behavioral video telehealth approach to address pain and heavy alcohol use among patients living with HIV and determine its feasibility and acceptability. Through an open pilot trial, this phase of this project will deliver an integrated alcohol-pain behavioral intervention to people living with HIV/AIDS (PLWHA) through videoconferencing. Intervention evaluation outcomes for this initial phase will include reduction of standard number of drinks per week, reduction in heavy drinking days, reduction of chronic pain severity and interference, ratings of patient satisfaction with treatment, and rate of treatment adherence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | participants all receive the intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivation and Cognitive Behavioral Management for Alcohol and Pain | Behavioral | Behavioral intervention that includes motivational, cognitive, and behavioral intervention strategies to reduce heavy drinking and chronic pain interference |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Pain Inventory Pain Severity | BPI consists of 11-point scale items that reflect pain severity and pain interference Average pain severity in the past 7-days is measures with a single 11-point scale where "0" is best and "10" is worst. Pain interference is measures as the mean of 7-items, each also rated on a 11-point scale where "0" is best and "10 is worst" Scales range from 0 - 10 | past 7 days |
| Brief Pain Inventory Pain Interference | BPI consists of 11-point scale items that reflect pain severity and pain interference Pain interference is measured as the mean of 7-items, each rated on a 11-point scale where "0" is best and "10 is worst" Scales range from 0 - 10 | past 7 days |
| Alcohol Time Line Follow Back...Heavy Drinking Episodes | number of heavy drinking episodes in the past 30 days | past 30 days |
| Alcohol Time Line Follow Back...Average Drinks Per Week | average number of drinks per week in the past 30 days (total number of drinks 30 days/4.28) | past 30 days |
| Client Satisfaction Questionnaire-8 [Modified] | Evaluative ratings of the intervention received. Eight Likert-scale items regarding different components of treatment satisfaction are rated from 1-4. Some items are reversed scored and then they are summed so that higher scores reflect higher satisfaction with treatment. The possible range of scores is 8-32. | past 30 days |
| Perceptions of Treatment Questionnaire | Participants were asked about their experiences with different facets of the intervention using items that were scored from 0 - 8 with higher scores reflecting greater satisfaction with the treatment components. |
| Measure | Description | Time Frame |
|---|---|---|
| Goal Systems Assessment Battery-Pain | Ratings self-regulatory capacities related to pain. Participants rate their perceived self-regulatory skills related to pain management using 5-point Likert scale items. There are 4 subscales for each of the dimensions of self-regulation assessed; planning, monitoring, self-efficacy, and value about the behavior change goal. A mean scale score is taken for each subscale. The range for each subscale is 0-4. Higher scores reflect better outcomes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tibor P Palfai, PhD | Boston University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Clinical Research Unit, Boston University | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39998790 | Derived | Palfai TP, Kratzer MPL, Taylor JL, Otis JD, Winter MR. Addressing Pain and Heavy Drinking among Patients in HIV-Care: A Pilot Study of an Integrated Telehealth Intervention. AIDS Behav. 2025 Jun;29(6):1930-1943. doi: 10.1007/s10461-025-04660-8. Epub 2025 Feb 25. |
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Recruited from medical clinic and ongoing cohort
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | 8 participants assigned to receive the intervention Motivation and Cognitive Behavioral Management for Alcohol and Pain: Behavioral intervention that includes motivational, cognitive, and behavioral intervention strategies to reduce heavy drinking and chronic pain interference |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | participants all receive the intervention Motivation and Cognitive Behavioral Management for Alcohol and Pain: Behavioral intervention that includes motivational, cognitive, and behavioral intervention strategies to reduce heavy drinking and chronic pain interference |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Brief Pain Inventory Pain Severity | BPI consists of 11-point scale items that reflect pain severity and pain interference Average pain severity in the past 7-days is measures with a single 11-point scale where "0" is best and "10" is worst. Pain interference is measures as the mean of 7-items, each also rated on a 11-point scale where "0" is best and "10 is worst" Scales range from 0 - 10 | Posted | Median | Standard Deviation | units on a scale | past 7 days |
|
8 weeks
no difference
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | 8 participants all receive the intervention Motivation and Cognitive Behavioral Management for Alcohol and Pain: Behavioral intervention that includes motivational, cognitive, and behavioral intervention strategies to reduce heavy drinking and chronic pain interference |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tibor Palfai, PhD | Boston University | 6173539345 | palfai@bu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 26, 2019 | Oct 24, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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Participants all undergo assessment and intervention
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| past 30 days |
| past 30 days |
| Goal Systems Assessment Battery-Alcohol | Ratings self-regulatory capacities related to moderating alcohol use. Participants rate their perceived self-regulatory skills related to pain management using 5-point Likert scale items. There are 4 subscales for each of the dimensions of self-regulation assessed; planning, monitoring, self-efficacy, and value about the behavior change goal. A mean scale score is taken for each subscale. The range for each subscale is 0-4. Higher scores reflect better outcomes. | past 30 days |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Brief Pain Inventory (BPI) | BPI consists of 11-point scale items that reflect pain severity and pain interference Average pain severity in the past 7-days is measures with a single 11-point scale where "0" is best and "10" is worst. Pain interference is measured as the mean of 7-items, each also rated on a 11-point scale where "0" is best and "10 is worst" Scales range from 0 - 10 | Median | Standard Deviation | units on a scale |
|
| Heavy Drinking Episodes | Calendar-based measure of the number of heavy drinking episodes in the past 30 days. | Median | Standard Deviation | episodes |
|
| Drinks/week from Timeline FollowBack | Calendar-based measure of the number of drinks per week over the prior month. The average drinks per week is computed by (Total drinks/4.28) | Median | Standard Deviation | drinks/week |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Brief Pain Inventory Pain Interference | BPI consists of 11-point scale items that reflect pain severity and pain interference Pain interference is measured as the mean of 7-items, each rated on a 11-point scale where "0" is best and "10 is worst" Scales range from 0 - 10 | Posted | Median | Standard Deviation | units on a scale | past 7 days |
|
|
|
| Primary | Alcohol Time Line Follow Back...Heavy Drinking Episodes | number of heavy drinking episodes in the past 30 days | Posted | Median | Standard Deviation | number of episodes | past 30 days |
|
|
|
| Primary | Alcohol Time Line Follow Back...Average Drinks Per Week | average number of drinks per week in the past 30 days (total number of drinks 30 days/4.28) | Posted | Median | Standard Deviation | drinks/week | past 30 days |
|
|
|
| Primary | Client Satisfaction Questionnaire-8 [Modified] | Evaluative ratings of the intervention received. Eight Likert-scale items regarding different components of treatment satisfaction are rated from 1-4. Some items are reversed scored and then they are summed so that higher scores reflect higher satisfaction with treatment. The possible range of scores is 8-32. | Posted | Mean | Standard Deviation | units on a scale | past 30 days |
|
|
|
| Primary | Perceptions of Treatment Questionnaire | Participants were asked about their experiences with different facets of the intervention using items that were scored from 0 - 8 with higher scores reflecting greater satisfaction with the treatment components. | Posted | Mean | Standard Deviation | units on a scale | past 30 days |
|
|
|
| Secondary | Goal Systems Assessment Battery-Pain | Ratings self-regulatory capacities related to pain. Participants rate their perceived self-regulatory skills related to pain management using 5-point Likert scale items. There are 4 subscales for each of the dimensions of self-regulation assessed; planning, monitoring, self-efficacy, and value about the behavior change goal. A mean scale score is taken for each subscale. The range for each subscale is 0-4. Higher scores reflect better outcomes. | Posted | Median | Standard Deviation | score on a scale | past 30 days |
|
|
|
| Secondary | Goal Systems Assessment Battery-Alcohol | Ratings self-regulatory capacities related to moderating alcohol use. Participants rate their perceived self-regulatory skills related to pain management using 5-point Likert scale items. There are 4 subscales for each of the dimensions of self-regulation assessed; planning, monitoring, self-efficacy, and value about the behavior change goal. A mean scale score is taken for each subscale. The range for each subscale is 0-4. Higher scores reflect better outcomes. | Posted | Median | Standard Deviation | units on a scale | past 30 days |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
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| D004327 | Drinking Behavior |
| D001519 | Behavior |
| Title | Measurements |
|---|---|
|
| Pain-Planning |
|
| Title | Measurements |
|---|---|
|
| Alcohol-Planning |
|