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临床试验/NCT04958200
NCT04958200已完成不适用

Integrated Technology-Based Intervention to Reduce Heavy Drinking and Chronic Pain Among Patients in Primary Care

Boston University Charles River Campus2 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2021年8月26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
49
试验地点
2
主要终点
Alcohol Time Line Followback (30)- Heavy Drinking Episode Days in the Past 30 Days

研究概览

简要总结

Chronic pain and unhealthy drinking are common co-occurring conditions among patients presenting to primary care. Given their impact on functioning and medical outcomes, there would be considerable benefit to developing an accessible, easily utilized, integrative approach to reduce unhealthy alcohol use and pain that can be readily incorporated into the primary care setting. The objective of this study is to test a smartphone-based intervention for reducing unhealthy alcohol use and pain in primary care patients, determine the feasibility of implementing this intervention in the primary care setting, provide effect size estimates of the intervention on drinking and chronic pain outcomes.

详细描述

Heavy alcohol use represents a significant risk for morbidity and mortality. Unfortunately, addressing unhealthy patterns of alcohol use in primary care is often a challenge as patients typically present with co-morbid conditions that: (1) may make unhealthy drinking a lower priority health issue and (2) may impact the capacity for sustained alcohol-related change. Chronic pain is among the most common of these conditions among primary care patients. Pain is a frequent source of distress and disability among primary care patients and is one of the most frequent causes for visits. Pain is also an important trigger for alcohol use among primary care patients who drink and is associated with the experience of negative alcohol-related consequences and unhealthy drinking over time. The experience of pain has also been shown to be associated with poorer responses to alcohol interventions. Primary care physicians face a number of challenges when attempting to treat co-occurring unhealthy drinking and pain among their patients. Pain management and reduction of alcohol use among those who engage in heavy alcohol use is often not adequately achieved with pharmacological treatments nor are pharmacological treatments indicated for common pain conditions. Moreover, despite the availability of evidence-based psychosocial interventions for unhealthy drinking and chronic pain, patients with each of these conditions typically show poor adherence to treatment. Given the rates of pain and unhealthy alcohol use among primary care patients and their impact on functioning and medical outcomes, there would be considerable benefit to an accessible, easily utilized, integrative approach to treat heavy alcohol use and pain that can be readily incorporated into the primary care setting. The objectives of this study are to develop a smartphone-based intervention for reducing heavy alcohol use and pain in primary care patients, determine the feasibility of implementing this intervention in the primary care setting, provide effect size estimates of the intervention on outcomes, and develop procedures to conduct a Stage II efficacy trial.

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

Eight-week and 16-week assessments will be completed by assessor who is masked to intervention condition. Baseline assessment takes place before randomization

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

  • 1 heavy drinking: defined as either [1] an average of more than 7(for women)/14 (for men) standard drinks per week over the past month or [2] one or more heavy drinking episodes (4+ standard drinks for women, 5+ standard drinks for men)
  • 2 chronic pain: defined as non-cancer related pain of at least 3 months duration rated as moderate or greater (past week pain severity rating of 4 or greater on the BPI severity item)

排除标准

  • psychoactive medication for pain or alcohol use for fewer than 2 months
  • history of bipolar disorder or schizophenia
  • current expressed suicidal intent
  • prior history of alcohol withdrawal related seizures or delirium tremens
  • behavioral treatment for pain or alcohol use in the past 3 months
  • any scheduled surgery within the next 6 months or acute life threatening illness that requires treatment

结局指标

主要结局

Alcohol Time Line Followback (30)- Heavy Drinking Episode Days in the Past 30 Days

时间窗: Past 30 days as assessed at the 16-week timepoint

Number of heavy drinking episode days (i.e., days with consumption of 5+ drinks men/4+ drinks women)

Alcohol Time Line Followback (30)- Average Drinks Per Week in the Past 30 Days

时间窗: Past 30 days as assessed at the 16-week timepoint

Average number of standard alcohol-containing drinks per week over the past 30 days

The Pain, Enjoyment of Life, General Activity (PEG) Scale

时间窗: Past 7 days as assessed at the 16-week timepoint

Three items which assess chronic pain intensity and interference. Range of each item is 0-10. Mean rating of the three items indicate the PEG pain score. range of scale is 0-10. Higher scores reflect worse outcomes

次要结局

  • Pain Intensity - Brief Pain Inventory (BPI) Items(past 7 days as assessed at the 16-week timepoint)
  • Pain Interference(past 7 days as assessed at the 16-week timepoint)

研究者

发起方
Boston University Charles River Campus
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tibor Palfai

Professor of Psychological and Brain Sciences

Boston University Charles River Campus

研究点 (2)

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