Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
385 participants
INTERVENTIONAL
2023-03-03
2026-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Motivational and Cognitive-Behavioral Management for Alcohol and Pain Intervention (MCBMAP)
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.
MCBMAP
MCBMAP integrates motivational interviewing (MI) and cognitive-behavioral skill training interventions for unhealthy drinking with cognitive-behavioral and self- management approaches for chronic pain. The intervention is delivered through internet-based videoconferencing and supplemented with web-based content to support the intervention. The initial treatment session provides a rationale for addressing alcohol and pain together in the context of HIV management, and initiates MI related to alcohol use. Participants receive 6 additional treatment sessions over the subsequent weeks.
Brief Advice and Information
Participants randomized to this arm will be provided treatment as usual for their conditions.
Brief Advice and Information
Through videoconferencing an interventionist will provide participants psychoeducation about the effects of alcohol and pain on HIV symptoms, advice/recommendations to reduce alcohol use, and a list of local treatment resources for alcohol and chronic pain.
Interventions
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MCBMAP
MCBMAP integrates motivational interviewing (MI) and cognitive-behavioral skill training interventions for unhealthy drinking with cognitive-behavioral and self- management approaches for chronic pain. The intervention is delivered through internet-based videoconferencing and supplemented with web-based content to support the intervention. The initial treatment session provides a rationale for addressing alcohol and pain together in the context of HIV management, and initiates MI related to alcohol use. Participants receive 6 additional treatment sessions over the subsequent weeks.
Brief Advice and Information
Through videoconferencing an interventionist will provide participants psychoeducation about the effects of alcohol and pain on HIV symptoms, advice/recommendations to reduce alcohol use, and a list of local treatment resources for alcohol and chronic pain.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Engaged in unhealthy drinking, defined as:
* \>7 drinks for women / \> 14 drinks for men per week.
* OR ≥ 3 drinks for women / ≥4 drinks for men on one occasion in the past month.
* Experiencing moderate or greater chronic pain (4 or greater on the numerical pain rating scale) for at least 3 months.
* Own a smart phone.
* Lives in the USA.
* Has a US mailing address.
Exclusion Criteria
* Unstable dose of psychoactive medication for pain or alcohol/substance use \[i.e., if on medication, participant has not been on same dose for least 2 months\]
* History of withdrawal-related seizures or delirium tremens
* Current non-pharmacological treatment for alcohol use disorder or chronic pain
* Acute life-threatening illness that requires treatment or intend to have surgery for a pain-related condition in the next 6-months.
* Current cancer-related pain
* Unable to provide one or more individuals for follow-up contact
* Individual who is unwilling to provide their sex at birth
* Limited or non-readers
18 Years
ALL
No
Sponsors
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National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
Boston University
OTHER
Responsible Party
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Principal Investigators
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Tibor P Palfai, PhD
Role: PRINCIPAL_INVESTIGATOR
Boston Medical Center, Psychiatry; BU Psychological & Brain Sciences
Locations
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Charles River Campus, Boston University, Psychology Department- remote study
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Palfai TP, Bernier LB, Kratzer MP, Magane KM, Fielman S, Otis JD, Heeren TC, Winter MR, Stein MD. Integrated telehealth intervention to reduce chronic pain and unhealthy drinking among people living with HIV: protocol for a randomized controlled trial. Addict Sci Clin Pract. 2024 Sep 5;19(1):64. doi: 10.1186/s13722-024-00493-3.
Other Identifiers
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H-42405
Identifier Type: -
Identifier Source: org_study_id
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