RECRUITING

Telehealth for Pain and Unhealthy Drinking Among PLWH

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Integrated Telehealth Intervention To Reduce Chronic Pain And Unhealthy Drinking Among People Living With HIV (PLWH)

Quick Facts

Study Start:2023-03-03
Study Completion:2026-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05503173

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Able to confirm HIV diagnosis, via visual evidence of antiretroviral (ART) medication bottle or medical record presented to study staff over Zoom.
  2. * Engaged in unhealthy drinking, defined as:
  3. * \>7 drinks for women / \> 14 drinks for men per week.
  4. * OR ≥ 3 drinks for women / ≥4 drinks for men on one occasion in the past month.
  5. * Experiencing moderate or greater chronic pain (4 or greater on the numerical pain rating scale) for at least 3 months.
  6. * Own a smart phone.
  7. * Lives in the USA.
  8. * Has a US mailing address.
  1. * History of bipolar, schizoaffective disorder or schizophrenia per self report.
  2. * Unstable dose of psychoactive medication for pain or alcohol/substance use \[i.e., if on medication, participant has not been on same dose for least 2 months\]
  3. * History of withdrawal-related seizures or delirium tremens
  4. * Current non-pharmacological treatment for alcohol use disorder or chronic pain
  5. * Acute life-threatening illness that requires treatment or intend to have surgery for a pain-related condition in the next 6-months.
  6. * Current cancer-related pain
  7. * Unable to provide one or more individuals for follow-up contact
  8. * Individual who is unwilling to provide their sex at birth
  9. * Limited or non-readers

Contacts and Locations

Study Contact

Tibor P Palfai, PhD
CONTACT
(617) 353-9345
palfai@bu.edu
Kara Magane, MS
CONTACT
(617) 358-1369
maganek@bu.edu

Principal Investigator

Tibor P Palfai, PhD
PRINCIPAL_INVESTIGATOR
Boston Medical Center, Psychiatry; BU Psychological & Brain Sciences

Study Locations (Sites)

Charles River Campus, Boston University, Psychology Department- remote study
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Boston University

  • Tibor P Palfai, PhD, PRINCIPAL_INVESTIGATOR, Boston Medical Center, Psychiatry; BU Psychological & Brain Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-03
Study Completion Date2026-02

Study Record Updates

Study Start Date2023-03-03
Study Completion Date2026-02

Terms related to this study

Keywords Provided by Researchers

  • Pain management
  • Telehealth
  • Unhealthy drinking
  • Ecological momentary assessment

Additional Relevant MeSH Terms

  • HIV
  • Chronic Pain
  • Unhealthy Alcohol Use