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Behavioral Intervention
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
Study 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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Rating of pain interference at 6 months
Rating of pain severity at 6 months
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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Who is running the clinical trial?
Boston UniversityLead Sponsor
454 Previous Clinical Trials
9,941,185 Total Patients Enrolled
4 Trials studying Chronic Pain
276 Patients Enrolled for Chronic Pain
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
801 Previous Clinical Trials
1,365,012 Total Patients Enrolled
9 Trials studying Chronic Pain
599 Patients Enrolled for Chronic Pain
Tibor P Palfai, PhDPrincipal InvestigatorBoston Medical Center, Psychiatry; BU Psychological & Brain Sciences
1 Previous Clinical Trials
8 Total Patients Enrolled
1 Trials studying Chronic Pain
8 Patients Enrolled for Chronic Pain
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been in pain (4 or more out of 10) for at least 3 months.I am experiencing pain due to my cancer.I drink more than the healthy limit.I can show proof of my HIV treatment through a medication bottle or medical record on Zoom.My dose for medication related to mental health, pain, or substance use has been stable for at least 2 months.I am currently receiving non-drug treatments for alcohol use or chronic pain.I cannot provide contact for follow-up.I don't have a severe illness needing immediate treatment or plans for surgery due to pain in the next 6 months.I am unwilling to disclose my sex assigned at birth.I have been diagnosed with bipolar, schizoaffective disorder, or schizophrenia.
Research Study Groups:
This trial has the following groups:- Group 1: Motivational and Cognitive-Behavioral Management for Alcohol and Pain Intervention (MCBMAP)
- Group 2: Brief Advice and Information
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals have chosen to partake in this scientific experiment?
"Affirmative. The clinical trial is currently seeking participants, as documented on clinicaltrials.gov. Initially posted on March 1st 2023 and last updated February 24th 2023, this medical study requires 385 enrollees from a single site."
Answered by AI
Is enrollment for this research venture currently underway?
"Confirmed. Information on clinicaltrials.gov demonstrates that the recruitment process for this trial is active and ongoing, having been initiated on March 1st 2023 with a subsequent edit made February 24th of the same year. 385 participants are needed from one particular medical centre."
Answered by AI
What is the ultimate objective of this investigation?
"The primary objective for this research, to be observed over a set timeline, is the amount of alcoholic beverages consumed per week. Secondary markers of success include depressive symptoms (assessed through PHQ-8), substance involvement in the past month (measured with NIDA's modified ASSIST procedure), and physical and mental functioning (utilizing RAND's 12-item Health Survey)."
Answered by AI
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