Alcohol Drinking and Chronic Pain Intervention, Control Condition
Conditions
Brief summary
This pilot study seeks to provide effect size estimates and test feasibility of a novel, integrated behavioral approach to reduce heavy drinking and chronic pain among patients in HIV-care delivered via internet-based videoconferencing.
Detailed description
This pilot study is a between-groups design to compare a novel integrated behavioral video telehealth intervention for heavy drinking PLWH with chronic pain to a control condition. Forty-eight heavy drinking patients in HIV-care with moderate or greater pain will be recruited for the study. Following baseline assessment, participants will be randomly assigned to either intervention or control conditions. Participants will complete assessment measures of heavy drinking and pain interference/severity at 3 and 6 months post-baseline. Secondary alcohol outcomes will include alcohol-related consequences
Interventions
BEHAVIORALMotivational and Cognitive-Behavioral Management for Alcohol and Pain (MCBMAP)
Videoconferencing intervention to reduce alcohol use and chronic pain interference and severity
BEHAVIORALTreatment as Usual
Psychoeducation and Information about Treatment Resources
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Boston University Charles River Campus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Three and six month assessments will be conducted by RA who is masked to intervention condition
Intervention model description
Compare Intervention to Control Condition in a Between Subjects Design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* engaged in HIV care, heavy drinking defined as more than 7/14 drinks per week for women/men or by a single episode of 4/5 (women/men), chronic (at least 3 months duration) moderate or greater (4 or more on the severity scale of the BPI, and non-cancer related pain
Exclusion criteria
* psychoactive medication for pain or alcohol use for fewer than 2 months * history of bipolar disorder or schizophrenia * current expressed suicidal intent * prior history of alcohol withdrawal related seizures or delirium tremens * current behavioral treatment for pain or alcohol use * any scheduled surgery within the next 6 months or acute life threatening illness that requires treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol Time Line Follow-Back (30)- Heavy Drinking Episodes | Past 30 days | Number of heavy drinking episodes NIAAA criteria (5+drinks men/ 4+ drinks women) |
| Alcohol Time Line Follow-Back (30) - Average Drinks per Week | Past 30 days | Average number of standard alcohol-containing drinks in the past 30 days |
| Brief Pain Inventory - Pain Severity | Past 7 days | BPI is an 11-point scale anchored with 0 best and 10 is worst Scale range 0-10 |
| Brief Pain Inventory - Pain Interference | Past 7-Days | BPI is an 11-point scale anchored with 0 best and 10 is worst Scale range 0-10. Pain Interference is measured as the mean of 7-items each rated on an 11-point scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Goal Systems Assessment Battery-Alcohol | Past 30 days | Ratings of self-regulatory capacities related to reducing alcohol use. Items are 5-point Likert-scales. There are 4 subscales utilized including planning, monitoring, self-efficacy, and value. Higher scores indicate better outcomes |
| Goal Systems Assessment Battery-Pain | Past 30 days | Ratings of self-regulatory capacities related to reducing alcohol use. Items are 5-point Likert-scales. There are 4 subscales utilized including planning, monitoring, self-efficacy, and value. Higher scores indicate better outcomes |
| Short Inventory of Alcohol Problems-Revised | 3 months | 17-item measure with 4-point Likert scale items ranging from 0 never to 3 daily/almost daily. Scale range 0-51 |
Countries
United States
Outcome results
None listed