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Completed

NCT Number: NCT04441593

Internet-based Video-conferencing to Address Alcohol Use and Pain: a Pilot Trial

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.

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Key information

Conditions

Alcohol Drinking and Chronic Pain Intervention Alcohol Drinking Behavior Control Condition Drinking Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston University Department of Psychological and Brain Sciences, Boston, Massachusetts, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral

Videoconferencing intervention to reduce alcohol use and chronic pain interference and severity

Other names: Intervention

Treatment as Usual

Behavioral

Psychoeducation and Information about Treatment Resources

Other names: Control

Primary outcomes

  1. Alcohol Time Line Follow-Back (30)- Heavy Drinking Episodes

    Time frame: Past 30 days

    Number of heavy drinking episodes NIAAA criteria (5+drinks men/ 4+ drinks women)

  2. Alcohol Time Line Follow-Back (30) - Average Drinks per Week

    Time frame: Past 30 days

    Average number of standard alcohol-containing drinks in the past 30 days

  3. Brief Pain Inventory - Pain Severity

    Time frame: Past 7 days

    BPI is an 11-point scale anchored with "0" best and "10" is worst Scale range 0-10

  4. Brief Pain Inventory - Pain Interference

    Time frame: 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 outcomes

  1. Short Inventory of Alcohol Problems-Revised

    Time frame: 3 months

    17-item measure with 4-point Likert scale items ranging from "0" never to "3" daily/almost daily. Scale range 0-51

  2. Goal Systems Assessment Battery-Alcohol

    Time frame: 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

  3. Goal Systems Assessment Battery-Pain

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Boston University Charles River Campus

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Internet-based Videoconferencing to Address Alcohol Use and Pain Among People With HIV

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jun 22, 2020
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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