Internet-based Videoconferencing to Address Alcohol Use and Pain

Chronic Pain Clinical Trial

Official title:

Internet-based Video-conferencing to Address Alcohol Use and Pain Among Heavy Drinkers in HIV-care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03982433
• Other study ID #: 4546
• Secondary ID: UH2AA026192
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: June 27, 2019

Study information

• Verified date: November 2019
• Source: Boston University Charles River Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 27, 2019
• Est. primary completion date: June 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use, Unspecified
• Chronic Pain

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

Locations

Country	Name	City	State
United States	General Clinical Research Unit, Boston University	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston University Charles River Campus	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	past 7 days
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	past 7 days
Primary	Alcohol Time Line Follow Back...Heavy Drinking Episodes	number of heavy drinking episodes in the past 30 days	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)	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.	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.	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.	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.	past 30 days