Integrated Telehealth Intervention To Reduce Chronic Pain And Unhealthy Drinking Among People Living With HIV (PLWH)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 253
- 试验地点
- 3
- 主要终点
- Number of heavy episodic drinking days the past month at 6 months
研究概览
简要总结
This randomized controlled trial is a between-groups design to compare the Motivational and Cognitive Behavioral Management for Alcohol and Pain (MCBMAP) Intervention to a Brief Advice and Information Control condition.
Two-hundred and fifty participants who have HIV with moderate or greater chronic pain will be randomized for the trial. Recruitment will take place through digital media. A unique feature of this intervention trial is that most of the procedures will be conducted remotely which will minimize barriers of transportation and time for participants. Consent and baseline assessment will be completed remotely. Following baseline assessment, participants will complete two weeks of ecological momentary assessment (EMA) to assess alcohol use, chronic pain, physical function and mechanisms of behavior change for alcohol and pain management. Following the two-week phase, participants will be randomly assigned to either the intervention or control condition and meet the interventionist through videoconferencing. Participants will complete outcome assessment measures at 3- and 6-months post-baseline. Following the 3-month outcome assessment, participants will complete another two weeks of EMA.
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
- 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
- 否
入选标准
- •Able to confirm HIV diagnosis, via visual evidence of antiretroviral (ART) medication bottle or medical record presented to study staff over Zoom.
- •Engaged in unhealthy drinking, defined as:
- •>7 drinks for women / > 14 drinks for men per week.
- •OR ≥ 3 drinks for women / ≥4 drinks for men on one occasion in the past month.
- •Experiencing moderate or greater chronic pain (4 or greater on the numerical pain rating scale) for at least 3 months.
- •Own a smart phone.
- •Lives in the USA.
- •Has a US mailing address.
排除标准
- •History of bipolar, schizoaffective disorder or schizophrenia per self report.
- •Unstable dose of psychoactive medication for pain or alcohol/substance use [i.e., if on medication, participant has not been on same dose for least 2 months]
- •History of withdrawal-related seizures or delirium tremens
- •Current non-pharmacological treatment for alcohol use disorder or chronic pain
- •Acute life-threatening illness that requires treatment or intend to have surgery for a pain-related condition in the next 6-months.
- •Current cancer-related pain
- •Unable to provide one or more individuals for follow-up contact
- •Individual who is unwilling to provide their sex at birth
- •Limited or non-readers
研究组 & 干预措施
Motivational and Cognitive-Behavioral Management for Alcohol and Pain Intervention (MCBMAP)
Participants randomized to this arm will receive MCBMAP which utilizes a self-regulation framework to integrate evidence-based approaches for chronic pain and unhealthy drinking.
干预措施: MCBMAP (Behavioral)
Brief Advice and Information
Participants randomized to this arm will be provided treatment as usual for their conditions.
干预措施: Brief Advice and Information (Other)
结局指标
主要结局
Number of heavy episodic drinking days the past month at 6 months
时间窗: 6 months
Assessed by the Timeline Follow Back (TLFB-30) which is a is a calendar that allows an assessor to obtain an estimate of an individual's daily drinking habits over a 30-day time period.
Number of alcoholic drinks consumed per week at 6 months
时间窗: 6 months
Assessed by the Timeline Follow Back (TLFB-30) which is a is a calendar that allows an assessor to obtain an estimate of an individual's daily drinking habits over a 30-day time period.
Rating of pain severity and interference at 6 months
时间窗: 6 months
Assessed by the PEG Scale Assessing Pain Intensity and Interference (PEG) which is a 3-item scale measuring pain intensity, emotional function, and physical function over the past week.
次要结局
- Rating of pain interference at 6 months(6 months)
- Rating of pain severity at 6 months(6 months)