Clinical trial NCT05503173: 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
Overall status: RECRUITING
Phase: NA
Conditions: HIV
Chronic Pain
Unhealthy Alcohol Use
Keywords: Pain management
Telehealth
Unhealthy drinking
Ecological momentary assessment
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2022-08-16
Enrollment: 385
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* Individual who is unwilling to provide their sex at birth
* Limited or non-readers

Primary outcomes:
measure: Number of alcoholic drinks consumed per week at 6 months
timeFrame: 6 months
measure: Number of heavy episodic drinking days the past month at 6 months
timeFrame: 6 months
measure: Rating of pain severity and interference at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Rating of pain severity at 6 months
timeFrame: 6 months
measure: Rating of pain interference at 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Charles River Campus, Boston University, Psychology Department- remote study
state: Massachusetts
Study officials:
affiliation: Boston Medical Center, Psychiatry; BU Psychological & Brain Sciences
name: Tibor P Palfai, PhD
role: PRINCIPAL_INVESTIGATOR
References: