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Telehealth for Pain and Unhealthy Drinking Among PLWH

Primary Purpose

HIV, Chronic Pain, Unhealthy Alcohol Use

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MCBMAP
Brief Advice and Information
Sponsored by
Boston University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV focused on measuring Pain management, Telehealth, Unhealthy drinking, Ecological momentary assessment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Able to confirm HIV diagnosis, via visual evidence of antiretroviral (ART) medication bottle or medical record presented to study staff over Zoom .

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:

  • History of bipolar, schizoaffective disorder or schizophrenia per self report.
  • 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

Sites / Locations

  • Charles River Campus, Boston University, Psychology Department- remote studyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Motivational and Cognitive-Behavioral Management for Alcohol and Pain Intervention (MCBMAP)

Brief Advice and Information

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Number of alcoholic drinks consumed per week at 6 months
Assessed by the Timeline Follow Back (TLFB-30) which is a is a calendar that allows an assessor to obtain an estimate of an individual's daily drinking habits over a 30-day time period.
Number of heavy episodic drinking days the past month at 6 months
Assessed by the Timeline Follow Back (TLFB-30) which is a is a calendar that allows an assessor to obtain an estimate of an individual's daily drinking habits over a 30-day time period.
Rating of pain severity and interference at 6 months
Assessed by the PEG Scale Assessing Pain Intensity and Interference (PEG) which is a 3-item scale measuring pain intensity, emotional function, and physical function over the past week.

Secondary Outcome Measures

Rating of pain severity at 6 months
Assessed by the Brief Pain Inventory (BPI) which a 9-item self-report questionnaire in which participants rate the severity of pain and the degree of pain interference with various dimensions of feeling and function. Related pain is rated on a 0-10 scale and scored as Worst Pain Score: 1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain.
Rating of pain interference at 6 months
Assessed by the Brief Pain Inventory (BPI) which a 9-item self-report questionnaire in which participants rate the severity of pain and the degree of pain interference with various dimensions of feeling and function. Related pain is rated on a 0-10 scale and scored as Worst Pain Score: 1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain.

Full Information

First Posted
August 13, 2022
Last Updated
August 9, 2023
Sponsor
Boston University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT05503173
Brief Title
Telehealth for Pain and Unhealthy Drinking Among PLWH
Official Title
Integrated Telehealth Intervention To Reduce Chronic Pain And Unhealthy Drinking Among People Living With HIV (PLWH)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 3, 2023 (Actual)
Primary Completion Date
February 2026 (Anticipated)
Study Completion Date
February 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Chronic Pain, Unhealthy Alcohol Use
Keywords
Pain management, Telehealth, Unhealthy drinking, Ecological momentary assessment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
385 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Motivational and Cognitive-Behavioral Management for Alcohol and Pain Intervention (MCBMAP)
Arm Type
Experimental
Arm Description
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.
Arm Title
Brief Advice and Information
Arm Type
Active Comparator
Arm Description
Participants randomized to this arm will be provided treatment as usual for their conditions.
Intervention Type
Behavioral
Intervention Name(s)
MCBMAP
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Brief Advice and Information
Other Intervention Name(s)
Treatment as usual
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of alcoholic drinks consumed per week at 6 months
Description
Assessed by the Timeline Follow Back (TLFB-30) which is a is a calendar that allows an assessor to obtain an estimate of an individual's daily drinking habits over a 30-day time period.
Time Frame
6 months
Title
Number of heavy episodic drinking days the past month at 6 months
Description
Assessed by the Timeline Follow Back (TLFB-30) which is a is a calendar that allows an assessor to obtain an estimate of an individual's daily drinking habits over a 30-day time period.
Time Frame
6 months
Title
Rating of pain severity and interference at 6 months
Description
Assessed by the PEG Scale Assessing Pain Intensity and Interference (PEG) which is a 3-item scale measuring pain intensity, emotional function, and physical function over the past week.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Rating of pain severity at 6 months
Description
Assessed by the Brief Pain Inventory (BPI) which a 9-item self-report questionnaire in which participants rate the severity of pain and the degree of pain interference with various dimensions of feeling and function. Related pain is rated on a 0-10 scale and scored as Worst Pain Score: 1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain.
Time Frame
6 months
Title
Rating of pain interference at 6 months
Description
Assessed by the Brief Pain Inventory (BPI) which a 9-item self-report questionnaire in which participants rate the severity of pain and the degree of pain interference with various dimensions of feeling and function. Related pain is rated on a 0-10 scale and scored as Worst Pain Score: 1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Able to confirm HIV diagnosis, via visual evidence of antiretroviral (ART) medication bottle or medical record presented to study staff over Zoom . 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: History of bipolar, schizoaffective disorder or schizophrenia per self report. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tibor P Palfai, PhD
Phone
(617) 353-9345
Email
palfai@bu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kara Magane, MS
Phone
(617) 358-1369
Email
maganek@bu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tibor P Palfai, PhD
Organizational Affiliation
Boston Medical Center, Psychiatry; BU Psychological & Brain Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charles River Campus, Boston University, Psychology Department- remote study
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kara Magane, MS
Phone
617-358-1369
Email
maganek@bu.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Telehealth for Pain and Unhealthy Drinking Among PLWH

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