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临床试验/NCT03982433
NCT03982433已完成不适用

Internet-based Video-conferencing to Address Alcohol Use and Pain Among Heavy Drinkers in HIV-care

Boston University Charles River Campus2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
8
试验地点
2
主要终点
Brief Pain Inventory Pain Severity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Brief Pain Inventory Pain Severity

时间窗: 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

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

时间窗: past 30 days

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

Client Satisfaction Questionnaire-8 [Modified]

时间窗: 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.

Brief Pain Inventory Pain Interference

时间窗: 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

Alcohol Time Line Follow Back...Heavy Drinking Episodes

时间窗: past 30 days

number of heavy drinking episodes in the past 30 days

Perceptions of Treatment Questionnaire

时间窗: 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.

次要结局

  • Goal Systems Assessment Battery-Alcohol(past 30 days)
  • Goal Systems Assessment Battery-Pain(past 30 days)

研究者

发起方
Boston University Charles River Campus
申办方类型
Other
责任方
Sponsor

研究点 (2)

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