Telehealth for Pain and Unhealthy Drinking Among PLWH

NCT05503173 | Recruiting

• 2 other identifiers: H-424051P01AA029546-01
• Study Type: interventional
• Target: 385
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV; Chronic Pain; Unhealthy Alcohol Use

Keywords

Pain management; Telehealth; Unhealthy drinking; Ecological momentary assessment

Outcome Measures

Primary Outcomes (3)

• Number of alcoholic drinks consumed per week at 6 months

  Assessed by the Timeline Follow Back (TLFB-30) which is a is a calendar that allows an assessor to obtain an estimate of an individual's daily drinking habits over a 30-day time period.

  6 months

• Number of heavy episodic drinking days the past month at 6 months

  Assessed by the Timeline Follow Back (TLFB-30) which is a is a calendar that allows an assessor to obtain an estimate of an individual's daily drinking habits over a 30-day time period.

  6 months

• Rating of pain severity and interference at 6 months

  Assessed by the PEG Scale Assessing Pain Intensity and Interference (PEG) which is a 3-item scale measuring pain intensity, emotional function, and physical function over the past week.

  6 months

Secondary Outcomes (2)

• Rating of pain severity at 6 months

  6 months

• Rating of pain interference at 6 months

  6 months

Study Arms (2)

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

EXPERIMENTAL

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.

Behavioral: MCBMAP

Brief Advice and Information

ACTIVE COMPARATOR

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

Other: Brief Advice and Information

Interventions

MCBMAP BEHAVIORAL

MCBMAP integrates motivational interviewing (MI) and cognitive-behavioral skill training interventions for unhealthy drinking with cognitive-behavioral and self- management approaches for chronic pain. The intervention is delivered through internet-based videoconferencing and supplemented with web-based content to support the intervention. The initial treatment session provides a rationale for addressing alcohol and pain together in the context of HIV management, and initiates MI related to alcohol use. Participants receive 6 additional treatment sessions over the subsequent weeks.

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

Brief Advice and Information OTHER

Through videoconferencing an interventionist will provide participants psychoeducation about the effects of alcohol and pain on HIV symptoms, advice/recommendations to reduce alcohol use, and a list of local treatment resources for alcohol and chronic pain.

Also known as: Treatment as usual

Brief Advice and Information

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Charles River Campus, Boston University, Psychology Department- remote study

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (1)

• Palfai TP, Bernier LB, Kratzer MP, Magane KM, Fielman S, Otis JD, Heeren TC, Winter MR, Stein MD. Integrated telehealth intervention to reduce chronic pain and unhealthy drinking among people living with HIV: protocol for a randomized controlled trial. Addict Sci Clin Pract. 2024 Sep 5;19(1):64. doi: 10.1186/s13722-024-00493-3.

  PMID: 39238059 DERIVED

MeSH Terms

Conditions

Chronic Pain; Agnosia

Interventions

Crisis Intervention; Therapeutics

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Tibor P Palfai, PhD

  Boston Medical Center, Psychiatry; BU Psychological & Brain Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tibor P Palfai, PhD

CONTACT

(617) 353-9345; palfai@bu.edu

Kara Magane, MS

CONTACT

(617) 358-1369; maganek@bu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2022
• First Posted: August 16, 2022
• Study Start: March 3, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)