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临床试验/NCT04059549
NCT04059549已完成不适用

Building and Pilot Testing a Couples-based Smartphone Systems to Address Alcohol Use Disorder

University of Wisconsin, Madison2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2020年11月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
68
试验地点
2
主要终点
Number of Participants With no Heavy Drinking

研究概览

简要总结

This project will develop and pilot test a new smartphone-based system for AUD patients, their partners, and clinicians called PartnerCHESS. PartnerCHESS will integrate key features of ABCT and A-CHESS. PartnerCHESS will also include a Clinician Report to automatically alert clinicians of patients at risk of relapse and offer other information on how recovery is proceeding. The project has three specific aims:

  1. Integrate A-CHESS with key features of ABCT to create PartnerCHESS to serve patients, partners, and clinicians.
  2. Conduct a pilot test (a small randomized clinical trial) of PartnerCHESS to estimate effect size and refine the protocol, procedures, recruitment strategy, measurements, and operations for use in a large RCT.

3a. Decide whether to pursue an R01 application, and if so, 3b. plan for the R01.

详细描述

Alcohol use disorder (AUD) is one of the most common substance use disorders. Yet only a small fraction of people who need treatment receive it, and most of them get only short-term support even though continuing care has been shown to be much more effective. Partner support can be critical to recovery, but many partners do not know how to support their partners' recovery or manage their own responses to it. Clinicians also lack evidence of the efforts patients are making toward recovery. Treating couples in which one member is recovering from AUD has been shown to be efficacious; in particular, Alcohol Behavioral Couples Therapy (ABCT) has shown positive outcomes. Still, ABCT has not been widely adopted, in part because of practical problems such as the stigma that goes with the partner needing to go to an addiction treatment agency to participate. A-CHESS is a smartphone-based system proven to substantially reduce relapse rates, but A-CHESS serves only the patient.

This project will develop and pilot test a new smartphone-based system for AUD patients, their partners, and clinicians called PartnerCHESS. PartnerCHESS will integrate key features of ABCT and A-CHESS. PartnerCHESS will also include a Clinician Report to automatically alert clinicians of patients at risk of relapse and offer other information on how recovery is proceeding. The project has three specific aims:

  1. Integrate A-CHESS with key features of ABCT to create PartnerCHESS to serve patients, partners, and clinicians.
  2. Conduct a pilot test (a small randomized clinical trial) of PartnerCHESS to estimate effect size and refine the protocol, procedures, recruitment strategy, measurements, and operations for use in a large RCT.

3a. Decide whether to pursue an R01 application, and if so, 3b. plan for the R01.

The project would engage 6 couples to help design PartnerCHESS, test its usability and give feedback on its utility. Once ready, the system would be tested by 34 other couples randomized to receive either PartnerCHESS + treatment as usual (TAU) or A-CHESS + TAU for a 6-month trial. The investigators will collect survey data at baseline, 2, 4, and 6 months and analyze it to see if a large clinical trial holds promise and, if so, produce an application to support a full-scale trial based on the technology developed and the research procedures employed in the pilot test.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Number of Participants With no Heavy Drinking

时间窗: baseline, 2, 4, and 6 months

At each time of measurement, a timeline follow-back interview was conducted for the past 60 days. Risky drinking day was be defined as greater than 4 drinks for men and greater than 3 drinks for women in 2 hours.

Percentage of Days With Any Drinking

时间窗: Baseline, 2, 4, 6 months

At each time of measurement, a timeline follow-back interview was conducted for the past 60 days.

Percentage of Days With Heavy Drinking

时间窗: baseline, 2, 4, and 6 months

At each time of measurement, a timeline follow-back interview was conducted for the past 60 days.

次要结局

  • Perceptions of Family Environment - Conflict(Baseline, 2, 4, 6 months)
  • Psychological Distress(baseline, 2, 4, and 6 months)
  • Commitment to Sobriety(Baseline, 2, 4, 6 months)
  • Relationship Satisfaction(baseline, 2, 4, and 6 months)
  • Perceptions of Family Environment - Cohesion(Baseline, 2, 4, 6 months)
  • Peer Support(Baseline, 2, 4, 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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