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Internet-based Videoconferencing to Address Alcohol Use and Pain

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ClinicalTrials.gov Identifier: NCT03982433
Recruitment Status : Completed
First Posted : June 11, 2019
Results First Posted : December 13, 2019
Last Update Posted : December 13, 2019
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Boston University Charles River Campus

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Chronic Pain
Alcohol Use, Unspecified
Intervention Behavioral: Motivation and Cognitive Behavioral Management for Alcohol and Pain
Enrollment 8
Recruitment Details Recruited from medical clinic and ongoing cohort
Pre-assignment Details  
Arm/Group Title Intervention
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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

Period Title: Overall Study
Started 8
Completed 7
Not Completed 1
Reason Not Completed
Lost to Follow-up             1
Arm/Group Title Intervention
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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

Overall Number of Baseline Participants 8
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[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants
53.3  (8.83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
1
  12.5%
Male
7
  87.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
6
  75.0%
White
2
  25.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants
8
Brief Pain Inventory (BPI)   [1] 
Median (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 8 participants
pain severity 5.5  (1.52)
pain interference 4.5  (2.24)
[1]
Measure 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 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

Heavy Drinking Episodes   [1] 
Median (Standard Deviation)
Unit of measure:  Episodes
Number Analyzed 8 participants
5.5  (5.62)
[1]
Measure Description: Calendar-based measure of the number of heavy drinking episodes in the past 30 days.
Drinks/week from Timeline FollowBack   [1] 
Median (Standard Deviation)
Unit of measure:  Drinks/week
Number Analyzed 8 participants
36.50  (18.43)
[1]
Measure Description: 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)
1.Primary Outcome
Title Brief Pain Inventory Pain Severity
Hide 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
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention
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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

Overall Number of Participants Analyzed 7
Median (Standard Deviation)
Unit of Measure: units on a scale
5.0  (2.58)
2.Primary Outcome
Title Brief Pain Inventory Pain Interference
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 7
Median (Standard Deviation)
Unit of Measure: units on a scale
2.43  (2.68)
3.Primary Outcome
Title Alcohol Time Line Follow Back...Heavy Drinking Episodes
Hide Description number of heavy drinking episodes in the past 30 days
Time Frame past 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 7
Median (Standard Deviation)
Unit of Measure: number of episodes
2.0  (4.34)
4.Primary Outcome
Title Alcohol Time Line Follow Back...Average Drinks Per Week
Hide 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
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 7
Median (Standard Deviation)
Unit of Measure: drinks/week
13  (21.57)
5.Primary Outcome
Title Client Satisfaction Questionnaire-8 [Modified]
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
29.29  (2.29)
6.Primary Outcome
Title Perceptions of Treatment Questionnaire
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
7.04  (1.15)
7.Secondary Outcome
Title Goal Systems Assessment Battery-Pain
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 7
Median (Standard Deviation)
Unit of Measure: score on a scale
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)
8.Secondary Outcome
Title Goal Systems Assessment Battery-Alcohol
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 7
Median (Standard Deviation)
Unit of Measure: units on a scale
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)
Time Frame 8 weeks
Adverse Event Reporting Description no difference
 
Arm/Group Title Intervention
Hide Arm/Group Description

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

All-Cause Mortality
Intervention
Affected / at Risk (%)
Total   0/8 (0.00%) 
Hide Serious Adverse Events
Intervention
Affected / at Risk (%)
Total   0/8 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intervention
Affected / at Risk (%)
Total   0/8 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Tibor Palfai, PhD
Organization: Boston University
Phone: 6173539345
EMail: palfai@bu.edu
Layout table for additonal information
Responsible Party: Boston University Charles River Campus
ClinicalTrials.gov Identifier: NCT03982433    
Other Study ID Numbers: 4546
UH2AA026192 ( U.S. NIH Grant/Contract )
First Submitted: May 14, 2019
First Posted: June 11, 2019
Results First Submitted: October 1, 2019
Results First Posted: December 13, 2019
Last Update Posted: December 13, 2019