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Trial record 78 of 122 for:    Behaviors and Mental Disorders[CONDITION-BROWSE-BRANCH] | Recruiting, Not yet recruiting, Available Studies | ( Map: Massachusetts, United States ) | NIH, U.S. Fed

Internet-based Videoconferencing to Address Alcohol Use and Pain

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ClinicalTrials.gov Identifier: NCT03982433
Recruitment Status : Recruiting
First Posted : June 11, 2019
Last Update Posted : June 11, 2019
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Boston University Charles River Campus

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Pain Alcohol Use, Unspecified Behavioral: Motivation and Cognitive Behavioral Management for Alcohol and Pain Not Applicable

Detailed Description:
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 PLWH 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Participants all undergo assessment and intervention
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Internet-based Video-conferencing to Address Alcohol Use and Pain Among Heavy Drinkers in HIV-care
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : August 30, 2019
Estimated Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
participants all receive the intervention
Behavioral: Motivation and Cognitive Behavioral Management for Alcohol and Pain
Behavioral intervention that includes motivational, cognitive, and behavioral intervention strategies to reduce heavy drinking and chronic pain interference
Other Name: MCBMAP




Primary Outcome Measures :
  1. Brief Pain Inventory pain severity [ Time Frame: past 7 days ]
    rating of average pain in the last 7 days

  2. Brief Pain Inventory pain interference [ Time Frame: past 7 days ]
    rating of pain interference in last 7 days

  3. Alcohol Time Line Follow Back...Heavy Drinking Episodes [ Time Frame: past 30 days ]
    number of heavy drinking episodes in the past month

  4. Alcohol Time Line Follow Back...Average Drinks Per Week [ Time Frame: past 30 days ]
    average number of drinks per week in the past month

  5. Client Satisfaction Questionnaire-8 [modified] [ Time Frame: past 30 days ]
    evaluative ratings of the intervention received

  6. Perceptions of Treatment Questionnaire [ Time Frame: past 30 days ]
    ratings of intervention


Secondary Outcome Measures :
  1. Goal Systems Assessment Battery-Pain [ Time Frame: past 30 days ]
    rating of self-regulatory capacities related to pain

  2. Goal Systems Assessment Battery-Alcohol [ Time Frame: past 30 days ]
    rating of self-regulatory capacities related to moderating alcohol use



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03982433


Contacts
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Contact: Tibor Palfai, PHD 617-353-9345 palfai@bu.edu

Locations
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United States, Massachusetts
General Clinical Research Unit, Boston University Recruiting
Boston, Massachusetts, United States, 02215
Contact: Ridiane Denis, MD    617-358-7558    ridianed@bu.edu   
Sponsors and Collaborators
Boston University Charles River Campus
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

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Responsible Party: Boston University Charles River Campus
ClinicalTrials.gov Identifier: NCT03982433     History of Changes
Other Study ID Numbers: 4546
First Posted: June 11, 2019    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Boston University Charles River Campus:
HIV

Additional relevant MeSH terms:
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Chronic Pain
Alcohol Drinking
Pain
Neurologic Manifestations
Signs and Symptoms
Drinking Behavior
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs