Telehealth MCBT for Chronic Pain & Problem Drinking in HIV/AIDS

N/A

Recruiting

Led By Tibor P Palfai, PhD

Research Sponsored by Boston University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial compares a remote Motivational & Cognitive Behavioral Intervention to a Brief Advice & Information Control to help HIV patients manage their alcohol use & chronic pain.

Who is the study for?

This trial is for adults in the USA with HIV/AIDS who have chronic pain (4+ on the pain scale) for at least 3 months and engage in unhealthy drinking. They must own a smartphone, confirm their HIV status via Zoom, and not be receiving current treatment for alcohol or pain issues. People with bipolar disorder, schizoaffective disorder, schizophrenia, unstable medication doses, history of severe withdrawal symptoms from alcohol, cancer-related pain or life-threatening illnesses are excluded.

What is being tested?

The study compares two approaches: MCBMAP (a motivational and cognitive behavioral management program) versus brief advice and information control condition to manage chronic pain and problem drinking among people living with HIV. Participants will use videoconferencing for sessions after an initial remote assessment phase including ecological momentary assessments over two weeks.

What are the potential side effects?

Since this trial involves behavioral interventions rather than medications or medical procedures, traditional side effects are not expected. However, participants may experience discomfort discussing personal habits like drinking or dealing with emotional responses during therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of alcoholic drinks consumed per week at 6 months

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

Rating of pain severity and interference at 6 months

Secondary study objectives

Rating of pain interference at 6 months

Rating of pain severity at 6 months

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Motivational and Cognitive-Behavioral Management for Alcohol and Pain Intervention (MCBMAP)Experimental Treatment1 Intervention

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.

Group II: Brief Advice and InformationActive Control1 Intervention

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

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