Back to resultsInternet-based Videoconferencing to Address Alcohol Use and Pain
Primary Purpose
Chronic Pain, Alcohol Use, Unspecified
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivation and Cognitive Behavioral Management for Alcohol and Pain
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring HIV
Eligibility Criteria
Inclusion Criteria:
- engaged in HIV care, heavy drinking by more than 7/14 drinks per week (women/men) or by 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 Brief Pain Inventory (BPI) non-cancer related pain.
Exclusion Criteria:
- psychoactive medication for pain or alcohol use for few than 2 months
- history of bipolar disorder, schizophrenia, other psychotic disorder
- current suicidal intent
- prior history of alcohol withdrawal related seizures or delirium tremens
- current behavioral treatment for pain or alcohol use
- any scheduled surgery within next 6 months or acute life-threatening illness that requires treatment
Sites / Locations
- General Clinical Research Unit, Boston University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
participants all receive the intervention
Outcomes
Primary Outcome Measures
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
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
Alcohol Time Line Follow Back...Heavy Drinking Episodes
number of heavy drinking episodes in the 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)
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT03982433
First Posted
May 14, 2019
Last Updated
November 21, 2019
Sponsor
Boston University Charles River Campus
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT03982433
Brief Title
Internet-based Videoconferencing to Address Alcohol Use and Pain
Official Title
Internet-based Video-conferencing to Address Alcohol Use and Pain Among Heavy Drinkers in HIV-care
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
June 27, 2019 (Actual)
Study Completion Date
June 27, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University Charles River Campus
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Alcohol Use, Unspecified
Keywords
HIV
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Participants all undergo assessment and intervention
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
participants all receive the intervention
Intervention Type
Behavioral
Intervention Name(s)
Motivation and Cognitive Behavioral Management for Alcohol and Pain
Intervention Description
Behavioral intervention that includes motivational, cognitive, and behavioral intervention strategies to reduce heavy drinking and chronic pain interference
Primary Outcome Measure Information:
Title
Brief Pain Inventory Pain Severity
Description
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
Title
Brief Pain Inventory Pain Interference
Description
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
Title
Alcohol Time Line Follow Back...Heavy Drinking Episodes
Description
number of heavy drinking episodes in the past 30 days
Time Frame
past 30 days
Title
Alcohol Time Line Follow Back...Average Drinks Per Week
Description
average number of drinks per week in the past 30 days (total number of drinks 30 days/4.28)
Time Frame
past 30 days
Title
Client Satisfaction Questionnaire-8 [Modified]
Description
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
Title
Perceptions of Treatment Questionnaire
Description
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
Secondary Outcome Measure Information:
Title
Goal Systems Assessment Battery-Pain
Description
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
Title
Goal Systems Assessment Battery-Alcohol
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
engaged in HIV care, heavy drinking by more than 7/14 drinks per week (women/men) or by 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 Brief Pain Inventory (BPI) non-cancer related pain.
Exclusion Criteria:
psychoactive medication for pain or alcohol use for few than 2 months
history of bipolar disorder, schizophrenia, other psychotic disorder
current suicidal intent
prior history of alcohol withdrawal related seizures or delirium tremens
current behavioral treatment for pain or alcohol use
any scheduled surgery within next 6 months or acute life-threatening illness that requires treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tibor P Palfai, PhD
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Clinical Research Unit, Boston University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Internet-based Videoconferencing to Address Alcohol Use and Pain
We'll reach out to this number within 24 hrs