Trial Outcomes & Findings for Internet-based Videoconferencing to Address Alcohol Use and Pain (NCT NCT03982433)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

past 7 days

Results posted on

2019-12-13

Participant Flow

Recruited from medical clinic and ongoing cohort

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	8
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Lost to Follow-up	1

Baseline Characteristics

Internet-based Videoconferencing to Address Alcohol Use and Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=8 Participants 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
Age, Continuous	53.3 years STANDARD_DEVIATION 8.83 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants
Brief Pain Inventory (BPI) pain severity	5.5 units on a scale STANDARD_DEVIATION 1.52 • n=5 Participants
Brief Pain Inventory (BPI) pain interference	4.5 units on a scale STANDARD_DEVIATION 2.24 • n=5 Participants
Heavy Drinking Episodes	5.5 episodes STANDARD_DEVIATION 5.62 • n=5 Participants
Drinks/week from Timeline FollowBack	36.50 drinks/week STANDARD_DEVIATION 18.43 • n=5 Participants

PRIMARY outcome

Timeframe: past 7 days

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

Outcome measures

Outcome measures
Measure	Intervention n=7 Participants 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
Brief Pain Inventory Pain Severity	5.0 units on a scale Standard Deviation 2.58

PRIMARY outcome

Timeframe: past 7 days

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

Outcome measures

Outcome measures
Measure	Intervention n=7 Participants 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
Brief Pain Inventory Pain Interference	2.43 units on a scale Standard Deviation 2.68

PRIMARY outcome

Timeframe: past 30 days

number of heavy drinking episodes in the past 30 days

Outcome measures

Outcome measures
Measure	Intervention n=7 Participants 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
Alcohol Time Line Follow Back...Heavy Drinking Episodes	2.0 number of episodes Standard Deviation 4.34

PRIMARY outcome

Timeframe: past 30 days

average number of drinks per week in the past 30 days (total number of drinks 30 days/4.28)

Outcome measures

Outcome measures
Measure	Intervention n=7 Participants 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
Alcohol Time Line Follow Back...Average Drinks Per Week	13 drinks/week Standard Deviation 21.57

PRIMARY outcome

Timeframe: past 30 days

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.

Outcome measures

Outcome measures
Measure	Intervention n=7 Participants 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
Client Satisfaction Questionnaire-8 [Modified]	29.29 units on a scale Standard Deviation 2.29

PRIMARY outcome

Timeframe: past 30 days

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.

Outcome measures

Outcome measures
Measure	Intervention n=7 Participants 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
Perceptions of Treatment Questionnaire	7.04 units on a scale Standard Deviation 1.15

SECONDARY outcome

Timeframe: past 30 days

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.

Outcome measures

Outcome measures
Measure	Intervention n=7 Participants 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
Goal Systems Assessment Battery-Pain Pain-Value	3.25 score on a scale Standard Deviation 0.70
Goal Systems Assessment Battery-Pain Pain-Self-efficacy	3.0 score on a scale Standard Deviation 0.84
Goal Systems Assessment Battery-Pain Pain-Monitoring	3.0 score on a scale Standard Deviation 0.92
Goal Systems Assessment Battery-Pain Pain-Planning	2.75 score on a scale Standard Deviation 0.89

SECONDARY outcome

Timeframe: past 30 days

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.

Outcome measures

Outcome measures
Measure	Intervention n=7 Participants 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
Goal Systems Assessment Battery-Alcohol Alcohol-Value	3.0 units on a scale Standard Deviation 0.87
Goal Systems Assessment Battery-Alcohol Alcohol-Self-efficacy	3.0 units on a scale Standard Deviation 0.71
Goal Systems Assessment Battery-Alcohol Alcohol-Monitoring	2.75 units on a scale Standard Deviation 0.82
Goal Systems Assessment Battery-Alcohol Alcohol-Planning	2.75 units on a scale Standard Deviation 0.89

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tibor Palfai, PhD

Boston University

Phone: 6173539345

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place