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Completed

NCT Number: NCT03982433

Internet-based Videoconferencing to Address Alcohol Use and Pain

This research seeks to develop a novel, integrated behavioral approach to reduce heavy drinking and chronic pain among patients in HIV-care delivered via internet-based videoconferencing. This first open trial pilot study seeks to recruit patients in the clinic through posted flyers, cards and physician referral.

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Key information

Conditions

Chronic Pain Alcohol Drinking Alcohol Use, Unspecified Behavior Drinking Behavior Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General Clinical Research Unit, Boston University

Boston, Massachusetts, 02215, United States

About this study

This study seeks to develop an integrated, behavioral video telehealth approach to address pain and heavy alcohol use among patients living with HIV and determine its feasibility and acceptability. Through an open pilot trial, this phase of this project will deliver an integrated alcohol-pain behavioral intervention to people living with HIV/AIDS (PLWHA) through videoconferencing. Intervention evaluation outcomes for this initial phase will include reduction of standard number of drinks per week, reduction in heavy drinking days, reduction of chronic pain severity and interference, ratings of patient satisfaction with treatment, and rate of treatment adherence.

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 by more than 7/14 drinks per week (women/men) or by 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 Brief Pain Inventory (BPI) non-cancer related pain.

Exclusion criteria

  • psychoactive medication for pain or alcohol use for few than 2 months
  • history of bipolar disorder, schizophrenia, other psychotic disorder
  • current suicidal intent
  • prior history of alcohol withdrawal related seizures or delirium tremens
  • current behavioral treatment for pain or alcohol use
  • any scheduled surgery within next 6 months or acute life-threatening illness that requires treatment

Treatment and study plan

Motivation and Cognitive Behavioral Management for Alcohol and Pain

Behavioral

Behavioral intervention that includes motivational, cognitive, and behavioral intervention strategies to reduce heavy drinking and chronic pain interference

Primary outcomes

  1. Brief Pain Inventory Pain Severity

    Time frame: past 7 days

    BPI consists of 11-point scale items that reflect pain severity and pain interference Average pain severity in the past 7-days is measures with a single 11-point scale where "0" is best and "10" is worst.

    Pain interference is measures as the mean of 7-items, each also rated on a 11-point scale where "0" is best and "10 is worst" Scales range from 0 - 10

  2. Brief Pain Inventory Pain Interference

    Time frame: past 7 days

    BPI consists of 11-point scale items that reflect pain severity and pain interference

    Pain interference is measured as the mean of 7-items, each rated on a 11-point scale where "0" is best and "10 is worst" Scales range from 0 - 10

  3. Alcohol Time Line Follow Back...Heavy Drinking Episodes

    Time frame: past 30 days

    number of heavy drinking episodes in the past 30 days

  4. Alcohol Time Line Follow Back...Average Drinks Per Week

    Time frame: past 30 days

    average number of drinks per week in the past 30 days (total number of drinks 30 days/4.28)

  5. Client Satisfaction Questionnaire-8 [Modified]

    Time frame: past 30 days

    Evaluative ratings of the intervention received. Eight Likert-scale items regarding different components of treatment satisfaction are rated from 1-4. Some items are reversed scored and then they are summed so that higher scores reflect higher satisfaction with treatment.

    The possible range of scores is 8-32.

  6. Perceptions of Treatment Questionnaire

    Time frame: past 30 days

    Participants were asked about their experiences with different facets of the intervention using items that were scored from 0 - 8 with higher scores reflecting greater satisfaction with the treatment components.

Secondary outcomes

  1. Goal Systems Assessment Battery-Pain

    Time frame: past 30 days

    Ratings self-regulatory capacities related to pain. Participants rate their perceived self-regulatory skills related to pain management using 5-point Likert scale items. There are 4 subscales for each of the dimensions of self-regulation assessed; planning, monitoring, self-efficacy, and value about the behavior change goal. A mean scale score is taken for each subscale. The range for each subscale is 0-4. Higher scores reflect better outcomes.

  2. Goal Systems Assessment Battery-Alcohol

    Time frame: past 30 days

    Ratings self-regulatory capacities related to moderating alcohol use. Participants rate their perceived self-regulatory skills related to pain management using 5-point Likert scale items. There are 4 subscales for each of the dimensions of self-regulation assessed; planning, monitoring, self-efficacy, and value about the behavior change goal. A mean scale score is taken for each subscale. The range for each subscale is 0-4. Higher scores reflect 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 Video-conferencing to Address Alcohol Use and Pain Among Heavy Drinkers in HIV-care

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 11, 2019
Registry last updated
Dec 13, 2019

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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