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

Recruiting in Palo Alto (17 mi)

Overseen by Tibor P Palfai, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Boston University

Must be taking: Antiretrovirals

Must not be taking: Psychoactive medications

Disqualifiers: Bipolar, Schizophrenia, Cancer pain, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of this treatment for chronic pain and problem drinking in HIV/AIDS?

Research shows that a videoconferencing intervention for chronic pain and heavy drinking among people with HIV/AIDS was well-received and feasible, with participants reporting high satisfaction and some improvements in drinking and pain. Additionally, cognitive-behavioral therapy (CBT) programs for chronic pain in HIV patients have shown significant improvements in pain intensity and functioning, suggesting that similar approaches could be beneficial. ^{1 2 3 4 5}

Is the telehealth MCBT treatment for chronic pain and problem drinking in HIV/AIDS safe for humans?

The studies suggest that the telehealth MCBT treatment is generally safe for humans, as participants reported high satisfaction and successfully completed sessions without any major safety concerns. The intervention was found to be acceptable and feasible, with improvements in pain and drinking behaviors, indicating it is a promising approach for people living with HIV/AIDS. ^{1 2 3 5 6}

What makes the MCBMAP treatment unique for chronic pain and 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, using a telehealth approach that allows patients to receive treatment through videoconferencing, making it more accessible and convenient. ^{1 2 5 6 7}

Research Team

Tibor P Palfai, PhD

Principal Investigator

Boston Medical Center, Psychiatry; BU Psychological & Brain Sciences

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Brief Advice and Information (Behavioral)
• MCBMAP (Behavioral Intervention)

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.

Participant Groups

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+

Sophie Kornowski

Boston University

Chief Executive Officer since 2022

MBA from the University of Chicago, Doctorate in Pharmacy from Paris Descartes University

Dr. Patrizia Cavazzoni

Boston University

Chief Medical Officer

MD from McGill University

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Dr. George F. Koob

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Chief Executive Officer since 2014

PhD in Neurobiology from the Scripps Research Institute

Dr. Patricia Powell

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Chief Medical Officer since 2015

MD from an accredited institution

Findings from Research

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]

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]

References

1. England 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. [2021]

2. England 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. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Pilot Randomized Trial of Collaborative Behavioral Treatment for Chronic Pain and Depression in Persons Living with HIV/AIDS. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Clinical and Workplace Outcomes From a Virtually Delivered Cognitive Behavioral Therapy Program for Pain. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Outcomes associated with a cognitive-behavioral chronic pain management program implemented in three public HIV primary care clinics. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Targeting Chronic Pain in Primary Care Settings by Using Behavioral Health Consultants: Methods of a Randomized Pragmatic Trial. [2022]

7. United States 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. [2020]