Internet-based Video-conferencing to Address Alcohol Use and Pain: a Pilot Trial

Control Condition Clinical Trial

Official title:

Internet-based Videoconferencing to Address Alcohol Use and Pain Among People With HIV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04441593
• Other study ID #: 4546 [Study 3]
• Secondary ID: UH3AA026192
• Status: Completed
• Phase: N/A
• Start date: December 23, 2020
• Est. completion date: February 2, 2024

Study information

• Verified date: March 2024
• Source: Boston University Charles River Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This pilot study seeks to provide effect size estimates and test feasibility of a novel, integrated behavioral approach to reduce heavy drinking and chronic pain among patients in HIV-care delivered via internet-based videoconferencing.

Description:

This pilot study is a between-groups design to compare a novel integrated behavioral video telehealth intervention for heavy drinking PLWH with chronic pain to a control condition. Forty-eight heavy drinking patients in HIV-care with moderate or greater pain will be recruited for the study. Following baseline assessment, participants will be randomly assigned to either intervention or control conditions. Participants will complete assessment measures of heavy drinking and pain interference/severity at 3 and 6 months post-baseline. Secondary alcohol outcomes will include alcohol-related consequences

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: February 2, 2024
• Est. primary completion date: February 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• engaged in HIV care, heavy drinking defined as more than 7/14 drinks per week for women/men or by a 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 BPI, and non-cancer related pain

Exclusion Criteria:

• psychoactive medication for pain or alcohol use for fewer than 2 months

• history of bipolar disorder or schizophrenia

• current expressed suicidal intent

• prior history of alcohol withdrawal related seizures or delirium tremens

• current behavioral treatment for pain or alcohol use

• any scheduled surgery within the next 6 months or acute life threatening illness that requires treatment

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Drinking and Chronic Pain Intervention
• Chronic Pain
• Control Condition

Intervention

Behavioral:
• Motivational and Cognitive-Behavioral Management for Alcohol and Pain (MCBMAP)
Videoconferencing intervention to reduce alcohol use and chronic pain interference and severity
• Treatment as Usual
Psychoeducation and Information about Treatment Resources

Locations

Country	Name	City	State
United States	Boston University Department of Psychological and Brain Sciences	Boston	Massachusetts
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	Alcohol Time Line Follow-Back (30)- Heavy Drinking Episodes	Number of heavy drinking episodes NIAAA criteria (5+drinks men/ 4+ drinks women)	Past 30 days
Primary	Alcohol Time Line Follow-Back (30) - Average Drinks per Week	Average number of standard alcohol-containing drinks in the past 30 days	Past 30 days
Primary	Brief Pain Inventory - Pain Severity	BPI is an 11-point scale anchored with "0" best and "10" is worst Scale range 0-10	Past 7 days
Primary	Brief Pain Inventory - Pain Interference	BPI is an 11-point scale anchored with "0" best and "10" is worst Scale range 0-10. Pain Interference is measured as the mean of 7-items each rated on an 11-point scale	Past 7-Days
Secondary	Short Inventory of Alcohol Problems-Revised	17-item measure with 4-point Likert scale items ranging from "0" never to "3" daily/almost daily. Scale range 0-51	3 months
Secondary	Goal Systems Assessment Battery-Alcohol	Ratings of self-regulatory capacities related to reducing alcohol use. Items are 5-point Likert-scales. There are 4 subscales utilized including planning, monitoring, self-efficacy, and value. Higher scores indicate better outcomes	Past 30 days
Secondary	Goal Systems Assessment Battery-Pain	Ratings of self-regulatory capacities related to reducing alcohol use. Items are 5-point Likert-scales. There are 4 subscales utilized including planning, monitoring, self-efficacy, and value. Higher scores indicate better outcomes	Past 30 days