An interventional study of Motivation and Cognitive Behavioral Management for Alcohol and Pain in Chronic Pain and Alcohol Use, Unspecified, sponsored by Boston University Charles River Campus. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-13.
Sponsored by Boston University Charles River Campus · Not applicable, Interventional, and Treatment
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.
2,998 studies on the registry are indexed under Chronic Pain; 706 are open to participants now.
This study's enrollment of 8 is below the median of 60 across 2,209 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Boston University Charles River Campus is the lead sponsor of 156 studies on the registry; 30 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 9 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
participants all receive the intervention
Behavioral: 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
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
Time frame: 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
Time frame: past 7 days
Alcohol Time Line Follow Back...Heavy Drinking Episodes
number of heavy drinking episodes in the past 30 days
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: past 30 days
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.
Time frame: 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.
Time frame: past 30 days
Recruited from medical clinic and ongoing cohort
| Milestone | Intervention |
|---|---|
| Started | 8 |
| Completed | 7 |
| Not completed | 1 |
| Withdrew: Lost to follow-up | 1 |
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
| units on a scale | Intervention |
|---|---|
| Brief Pain Inventory Pain Severity | 5.0 ± 2.58 |
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
| units on a scale | Intervention |
|---|---|
| Brief Pain Inventory Pain Interference | 2.43 ± 2.68 |
number of heavy drinking episodes in the past 30 days
| number of episodes | Intervention |
|---|---|
| Alcohol Time Line Follow Back...Heavy Drinking Episodes | 2.0 ± 4.34 |
average number of drinks per week in the past 30 days (total number of drinks 30 days/4.28)
| drinks/week | Intervention |
|---|---|
| Alcohol Time Line Follow Back...Average Drinks Per Week | 13 ± 21.57 |
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.
| units on a scale | Intervention |
|---|---|
| Client Satisfaction Questionnaire-8 [Modified] | 29.29 ± 2.29 |
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.
| units on a scale | Intervention |
|---|---|
| Perceptions of Treatment Questionnaire | 7.04 ± 1.15 |
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.
| score on a scale | Intervention |
|---|---|
| Pain-Value | 3.25 ± 0.70 |
| Pain-Self-efficacy | 3.0 ± 0.84 |
| Pain-Monitoring | 3.0 ± 0.92 |
| Pain-Planning | 2.75 ± 0.89 |
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.
| units on a scale | Intervention |
|---|---|
| Alcohol-Value | 3.0 ± 0.87 |
| Alcohol-Self-efficacy | 3.0 ± 0.71 |
| Alcohol-Monitoring | 2.75 ± 0.82 |
| Alcohol-Planning | 2.75 ± 0.89 |
Collected over 8 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Age, Continuous(years) | Intervention |
|---|---|
| Mean | 53.3 ± 8.83 |
| Sex: Female, Male(Participants) | Intervention |
|---|---|
| Female | 1 |
| Male | 7 |
| Race (NIH/OMB)(Participants) | Intervention |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 6 |
| White | 2 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Intervention |
|---|---|
| United States | 8 |
| Brief Pain Inventory (BPI)(units on a scale) | Intervention |
|---|---|
| pain severity | 5.5 ± 1.52 |
| pain interference | 4.5 ± 2.24 |
| Heavy Drinking Episodes(episodes) | Intervention |
|---|---|
| Median | 5.5 ± 5.62 |
| Drinks/week from Timeline FollowBack(drinks/week) | Intervention |
|---|---|
| Median | 36.50 ± 18.43 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Mar 2019 to primary completion in Jun 2019, 3 months.
Results were first posted in Dec 2019, 5 months after primary completion.
Of 1,209 non-industry interventional studies with no phase under Chronic Pain, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 39. This study's 3 months is below that.
Counting every sponsor, half of 1,296 studies reached it within 21 months; a quarter within 9 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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