Telehealth for Pain and Unhealthy Drinking Among PLWH

Boston University

Status: Enrolling

Conditions: HIV; Chronic Pain; Unhealthy Alcohol Use

Treatments: Behavioral: MCBMAP; Other: Brief Advice and Information

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05503173

1P01AA029546-01 (U.S. NIH Grant/Contract)

H-42405

Details and patient eligibility

About

This randomized controlled trial is a between-groups design to compare the Motivational and Cognitive Behavioral Management for Alcohol and Pain (MCBMAP) Intervention to a Brief Advice and Information Control condition.

Two-hundred and fifty participants who have HIV with moderate or greater chronic pain will be randomized for the trial. Recruitment will take place through digital media. A unique feature of this intervention trial is that most of the procedures will be conducted remotely which will minimize barriers of transportation and time for participants. Consent and baseline assessment will be completed remotely. Following baseline assessment, participants will complete two weeks of ecological momentary assessment (EMA) to assess alcohol use, chronic pain, physical function and mechanisms of behavior change for alcohol and pain management. Following the two-week phase, participants will be randomly assigned to either the intervention or control condition and meet the interventionist through videoconferencing. Participants will complete outcome assessment measures at 3- and 6-months post-baseline. Following the 3-month outcome assessment, participants will complete another two weeks of EMA.

Enrollment: 385 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Able to confirm HIV diagnosis, via visual evidence of antiretroviral (ART) medication bottle or medical record presented to study staff over Zoom.
• Engaged in unhealthy drinking, defined as:
• >7 drinks for women / > 14 drinks for men per week.
• OR ≥ 3 drinks for women / ≥4 drinks for men on one occasion in the past month.
• Experiencing moderate or greater chronic pain (4 or greater on the numerical pain rating scale) for at least 3 months.
• Own a smart phone.
• Lives in the USA.
• Has a US mailing address.

Exclusion criteria

• History of bipolar, schizoaffective disorder or schizophrenia per self report.
• Unstable dose of psychoactive medication for pain or alcohol/substance use [i.e., if on medication, participant has not been on same dose for least 2 months]
• History of withdrawal-related seizures or delirium tremens
• Current non-pharmacological treatment for alcohol use disorder or chronic pain
• Acute life-threatening illness that requires treatment or intend to have surgery for a pain-related condition in the next 6-months.
• Current cancer-related pain
• Unable to provide one or more individuals for follow-up contact
• Individual who is unwilling to provide their sex at birth
• Limited or non-readers

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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385 participants in 2 patient groups

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

Experimental group

Description:

Participants randomized to this arm will receive MCBMAP which utilizes a self-regulation framework to integrate evidence-based approaches for chronic pain and unhealthy drinking.

Treatment:

Behavioral: MCBMAP

Brief Advice and Information

Active Comparator group

Description:

Participants randomized to this arm will be provided treatment as usual for their conditions.

Treatment:

Other: Brief Advice and Information