385 Participants Needed

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

TP
NR
KM
Overseen ByKara Magane, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Boston University
Must be taking: Antiretrovirals
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.12345

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.12356

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.12567

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.

Research Team

TP

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.
See 3 more

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.
See 6 more

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
  • 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.
Participant Groups
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.

Find a Clinic Near You

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+

Findings from Research

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.
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 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.
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.
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]

References

An integrated videoconferencing intervention for chronic pain and heavy drinking among patients in HIV-care: a proof-of-concept study. [2021]
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]
Pilot Randomized Trial of Collaborative Behavioral Treatment for Chronic Pain and Depression in Persons Living with HIV/AIDS. [2018]
Clinical and Workplace Outcomes From a Virtually Delivered Cognitive Behavioral Therapy Program for Pain. [2020]
Outcomes associated with a cognitive-behavioral chronic pain management program implemented in three public HIV primary care clinics. [2021]
Targeting Chronic Pain in Primary Care Settings by Using Behavioral Health Consultants: Methods of a Randomized Pragmatic Trial. [2022]
HealthCall delivered via smartphone to reduce co-occurring drug and alcohol use in HIV-infected adults: A randomized pilot trial. [2020]
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