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

Sponsor

Boston University Charles River Campus (Other)

Overall Status

Recruiting

CT.gov ID

NCT04441593

Collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)

Enrollment

Locations

Arms

20.2

Anticipated Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Drinking and Chronic Pain Intervention Control Condition	Behavioral: Motivational and Cognitive-Behavioral Management for Alcohol and Pain (MCBMAP) Behavioral: Treatment as Usual	N/A

Detailed 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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Compare Intervention to Control Condition in a Between Subjects DesignCompare Intervention to Control Condition in a Between Subjects Design

Masking:

Single (Outcomes Assessor)

Masking Description:

Three and six month assessments will be conducted by RA who is masked to intervention condition

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 23, 2020

Anticipated Primary Completion Date :

Mar 30, 2022

Anticipated Study Completion Date :

Aug 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Videoconferencing Intervention for Heavy Drinking and Chronic Pain	Behavioral: Motivational and Cognitive-Behavioral Management for Alcohol and Pain (MCBMAP) Videoconferencing intervention to reduce alcohol use and chronic pain interference and severity Other Names: Intervention
Active Comparator: Control Treatment as Usual	Behavioral: Treatment as Usual Psychoeducation and Information about Treatment Resources Other Names: Control

Arm

Intervention/Treatment

Experimental: Intervention

Videoconferencing Intervention for Heavy Drinking and Chronic Pain

Behavioral: Motivational and Cognitive-Behavioral Management for Alcohol and Pain (MCBMAP)

Videoconferencing intervention to reduce alcohol use and chronic pain interference and severity

Other Names:

Intervention

Active Comparator: Control

Treatment as Usual

Behavioral: Treatment as Usual

Psychoeducation and Information about Treatment Resources

Other Names:

Control

Outcome Measures

Primary Outcome Measures

Alcohol Time Line Follow-Back (30)- Heavy Drinking Episodes [Past 30 days]
Number of heavy drinking episodes NIAAA criteria (5+drinks men/ 4+ drinks women)
Alcohol Time Line Follow-Back (30) - Average Drinks per Week [Past 30 days]
Average number of standard alcohol-containing drinks in the past 30 days
Brief Pain Inventory - Pain Severity [Past 7 days]
BPI is an 11-point scale anchored with "0" best and "10" is worst Scale range 0-10
Brief Pain Inventory - Pain Interference [Past 7-Days]
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

Secondary Outcome Measures

Short Inventory of Alcohol Problems-Revised [3 months]
17-item measure with 4-point Likert scale items ranging from "0" never to "3" daily/almost daily. Scale range 0-51
Goal Systems Assessment Battery-Alcohol [Past 30 days]
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
Goal Systems Assessment Battery-Pain [Past 30 days]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Boston University Department of Psychological and Brain Sciences	Boston	Massachusetts	United States	02215
2	General Clinical Research Unit, Boston University	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Boston University Charles River Campus

ClinicalTrials.gov Identifier:

NCT04441593

Other Study ID Numbers:

4546 [Study 3]
UH3AA026192

First Posted:

Jun 22, 2020

Last Update Posted:

Jan 5, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Chronic Pain

Alcohol Drinking

Study Results

No Results Posted as of Jan 5, 2021