Internet-based Videoconferencing to Address Alcohol Use and Pain Among People With HIV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 4
- 主要终点
- Brief Pain Inventory - Pain Severity
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Three and six month assessments will be conducted by RA who is masked to intervention condition
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Brief Pain Inventory - Pain Severity
时间窗: 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
时间窗: 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
Alcohol Time Line Follow-Back (30)- Heavy Drinking Episodes
时间窗: 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
时间窗: Past 30 days
Average number of standard alcohol-containing drinks in the past 30 days
次要结局
- Short Inventory of Alcohol Problems-Revised(3 months)
- Goal Systems Assessment Battery-Pain(Past 30 days)
- Goal Systems Assessment Battery-Alcohol(Past 30 days)