About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

>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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

MCBMAP
Behavioral
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
Other intervention
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.

Treatment groups

385 Participants

are divided into 2 treatment groups

Group A: Motivational and Cognitive-Behavioral Management for Alcohol and Pain Intervention (MCBMAP)Experimental treatment 1 intervention

Group B: Brief Advice and InformationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame

6 months

2

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.

Time frame

6 months

3

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.

Time frame

6 months

Secondary outcomes

1

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.

Time frame

6 months

2

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.

Time frame

6 months

Telehealth for Pain and Unhealthy Drinking Among PLWH

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts