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

Overseen By Kara Magane, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston University

Must be taking: Antiretrovirals

Must not be taking: Psychoactive medications

Disqualifiers: Bipolar, Schizophrenia, Cancer pain, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

385 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to assist people with HIV who face both chronic pain and problem drinking. Researchers aim to determine if a program called Motivational and Cognitive-Behavioral Management for Alcohol and Pain (MCBMAP) is more effective than standard advice in managing these issues. Individuals with HIV who have experienced chronic pain for more than three months and drink heavily might be suitable candidates. Most of the trial occurs remotely, allowing participants to join without travel concerns. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance the quality of life for many.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you need to have been on a stable dose of any psychoactive medication for pain or alcohol/substance use for at least 2 months before joining.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Motivational and Cognitive-Behavioral Management for Alcohol and Pain (MCBMAP) program is safe for individuals with HIV/AIDS who experience chronic pain and problem drinking. Delivered through telehealth, this program uses methods proven to manage pain and reduce unhealthy drinking.

While specific data on MCBMAP's side effects is not yet available, similar therapies are usually well-tolerated. Participants in previous studies have generally reported few side effects. The telehealth format further reduces the risk of side effects, as it does not involve medication or physical treatments.

The use of MCBMAP in this trial reflects confidence in its safety, especially since the trial is designed for easy and accessible remote participation. Overall, this program is expected to be low-risk while providing support for managing both pain and problem drinking. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MCBMAP treatment because it combines motivational and cognitive-behavioral strategies specifically tailored for people with chronic pain and problem drinking in the context of HIV/AIDS. Unlike standard treatments that often address these issues separately, MCBMAP integrates evidence-based approaches to tackle both chronic pain and unhealthy drinking simultaneously. This holistic, self-regulation framework offers a more comprehensive solution, potentially leading to better outcomes for individuals managing these complex co-occurring conditions.

What evidence suggests that this trial's treatments could be effective for chronic pain and problem drinking in HIV/AIDS?

Research has shown that the Motivational and Cognitive-Behavioral Management for Alcohol and Pain (MCBMAP) program, which participants in this trial may receive, can reduce chronic pain and unhealthy drinking in people with HIV/AIDS. This program employs motivational techniques and cognitive-behavioral strategies to help participants manage pain and control drinking. Early results suggest that this telehealth approach improves physical function and encourages positive behavior changes, making it easier for patients to manage their conditions. The program's unique focus on treating both issues simultaneously offers promising results for those facing chronic pain and alcohol-related challenges. Another group in this trial will receive Brief Advice and Information as a standard treatment for their conditions. ^{1 2 4 6 7}

Who Is on the Research Team?

Tibor P Palfai, PhD

Principal Investigator

Boston Medical Center, Psychiatry; BU Psychological & Brain Sciences

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been in pain (4 or more out of 10) for at least 3 months.

I drink more than the healthy limit.

I can show proof of my HIV treatment through a medication bottle or medical record on Zoom.

Exclusion Criteria

History of withdrawal-related seizures or delirium tremens

I am experiencing pain due to my cancer.

My dose for medication related to mental health, pain, or substance use has been stable for at least 2 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Remote consent and baseline assessment

Ecological Momentary Assessment (EMA)

Participants complete two weeks of EMA to assess alcohol use, chronic pain, physical function, and mechanisms of behavior change

2 weeks

Remote assessments

Treatment

Participants are randomly assigned to either the MCBMAP intervention or Brief Advice and Information control condition

3 months

Remote videoconferencing sessions

Follow-up

Participants complete outcome assessment measures at 3- and 6-months post-baseline and another two weeks of EMA after the 3-month assessment

6 months

Remote assessments

What Are the Treatments Tested in This Trial?

Interventions

• Brief Advice and Information
• MCBMAP

Trial Overview 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.

How Is the Trial Designed?

Group I: Motivational and Cognitive-Behavioral Management for Alcohol and Pain Intervention (MCBMAP) Experimental Treatment 1 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 Information Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Boston University

Lead Sponsor

Trials

494

Recruited

9,998,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

The study will evaluate the effectiveness of monthly telehealth booster contacts in enhancing the outcomes of the Brief Cognitive Behavioral Therapy for Chronic Pain (BCBT-CP) among 716 patients with chronic pain, assessing results at multiple time points (3, 6, 12, and 18 months).

This pragmatic trial aims to determine if these booster contacts can help sustain the benefits of BCBT-CP, which is a nonpharmacological approach to pain management integrated into primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting Chronic Pain in Primary Care Settings by Using Behavioral Health Consultants: Methods of a Randomized Pragmatic Trial. Goodie, JL., Kanzler, KE., McGeary, CA., et al.[2022]

The MI+HealthCall intervention, which combines Motivational Interviewing with smartphone technology, showed high feasibility with a 95% daily use rate and excellent patient satisfaction (4.5 out of 5) among adults living with HIV.

Participants using MI+HealthCall experienced significantly greater reductions in drug use and spending compared to those receiving only Motivational Interviewing, indicating its potential effectiveness in addressing substance use issues that can hinder HIV treatment adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HealthCall delivered via smartphone to reduce co-occurring drug and alcohol use in HIV-infected adults: A randomized pilot trial. Aharonovich, E., Stohl, M., Cannizzaro, D., et al.[2020]

A tailored videoconferencing intervention for people living with HIV/AIDS was found to be highly acceptable and feasible, with participants successfully completing an average of 4.5 out of 6 sessions.

The intervention showed promise in addressing chronic pain and heavy drinking, indicating its potential utility for improving treatment outcomes in this population, warranting further efficacy studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An integrated videoconferencing intervention for chronic pain and heavy drinking among patients in HIV-care: a proof-of-concept study. Palfai, TP., Saitz, R., Kratzer, MPL., et al.[2021]

A 12-week cognitive-behavioral therapy (CBT) program for HIV-positive patients with chronic pain showed significant improvements in pain intensity and related functioning, with effect sizes of -0.83 and -0.43, respectively.

Despite moderate attendance, the CBT program led to enhanced mental health and reduced anxiety, suggesting that integrating CBT into primary care could be a beneficial alternative to traditional analgesics for managing chronic pain in HIV/AIDS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes associated with a cognitive-behavioral chronic pain management program implemented in three public HIV primary care clinics. Trafton, JA., Sorrell, JT., Holodniy, M., et al.[2021]

A study involving 10 participants living with HIV, chronic pain, and heavy drinking revealed that videoconferencing is an acceptable method for delivering interventions to address these co-occurring issues.

Thematic analysis of interviews identified key areas for intervention, such as coping strategies, treatment preferences, and the impact of alcohol on health, which can help tailor future telehealth programs for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a tailored, telehealth intervention to address chronic pain and heavy drinking among people with HIV infection: integrating perspectives of patients in HIV care. Palfai, TP., Taylor, JL., Saitz, R., et al.[2020]

The pilot study involving 23 participants showed that the HIV-PASS intervention for managing pain and depressive symptoms in individuals living with HIV/AIDS was feasible and well-accepted, with participants attending an average of over 5 out of 7 sessions.

HIV-PASS demonstrated positive effects on pain-related interference with functioning and other outcomes, indicating it may be a promising approach for improving the quality of life in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Randomized Trial of Collaborative Behavioral Treatment for Chronic Pain and Depression in Persons Living with HIV/AIDS. Uebelacker, LA., Weisberg, RB., Herman, DS., et al.[2018]

A retrospective analysis of 1,086 participants in a virtual behavioral therapy program showed significant improvements in pain severity (17% reduction) and pain interference (27% reduction) over 8 weeks, indicating the program's efficacy in pain management.

Participants also experienced notable reductions in behavioral health symptoms such as depression, anxiety, and stress, along with over 25% improvements in work productivity and activity impairment, highlighting the program's positive impact on overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and Workplace Outcomes From a Virtually Delivered Cognitive Behavioral Therapy Program for Pain. Mochari-Greenberger, H., Andreopoulos, E., Peters, A., et al.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39238059/

Integrated telehealth intervention to reduce chronic pain and ... This paper describes a research study protocol of an integrated telehealth intervention to reduce unhealthy drinking and chronic pain among PLWH ...

2. reporter.nih.gov reporter.nih.gov/search/14E9CE024F8FC5D27598B8961CAA4A01A2FFCEB861BF/project-details/11171617

Integrated telehealth intervention to reduce chronic pain ... The current study seeks to test the efficacy of this intervention for reducing unhealthy drinking and chronic pain in a fully-scaled, randomized controlled ...

3. ascpjournal.biomedcentral.com ascpjournal.biomedcentral.com/articles/10.1186/s13722-024-00493-3

Integrated telehealth intervention to reduce chronic pain and ... This paper describes a research study protocol of an integrated telehealth intervention to reduce unhealthy drinking and chronic pain among PLWH

4. withpower.com withpower.com/trial/telehealth-mcbt-for-chronic-pain-problem-drinking-in-hivaids-85df1

Telehealth MCBT for Chronic Pain & Problem Drinking in HIV/AIDS MCBMAP is unique because it combines motivational and cognitive-behavioral techniques to address both chronic pain and problem drinking in people with HIV/AIDS, ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04441593

Internet-based Video-conferencing to Address Alcohol Use ... This pilot study seeks to provide effect size estimates and test feasibility of a novel, integrated behavioral approach to reduce heavy drinking and chronic ...

6. bu.trialstoday.org bu.trialstoday.org/trial/NCT05503173

Telehealth for Pain and Unhealthy Drinking Among PLWH Motivational and Cognitive-Behavioral Management for Alcohol and Pain Intervention (MCBMAP) ... chronic pain and unhealthy drinking. Behavioral: ...

7. sciencedirect.com sciencedirect.com/science/article/am/pii/S0376871624000425

Mobile health intervention to address chronic pain among ... Alcohol Outcomes. The primary alcohol outcomes were frequency of heavy drinking episodes (women > 3 per occasion, men > 4 per occasion) in the past 30-days ...