Building and Pilot Testing a Couples-based Smartphone Systems to Address Alcohol Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Percentage of Days With 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:
- Integrate A-CHESS with key features of ABCT to create PartnerCHESS to serve patients, partners, and clinicians.
- 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:
- Integrate A-CHESS with key features of ABCT to create PartnerCHESS to serve patients, partners, and clinicians.
- 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
- 否
入选标准
- •A total of 34 dyads were recruited.
- •Patients and partners:
- •Must be 18 or older
- •Not have a mental or physical condition that limits smartphone use
- •Cannot have experienced serious Interpersonal Violence Intimate Partner Violence (IPV) in the index (therapy) relationship in the past year
- •Not have a history of schizophrenia
- •Must have a DSM-5 diagnosis of alcohol use disorder or meet NIAAA guidelines for risky drinking.
- •Have had at least one alcoholic drink in the last 6 months
- •Must be a spouse, or in a 6-month or longer committed romantic relationship
- •Willing to participate in the study
排除标准
- 未提供
研究组 & 干预措施
A-CHESS Drinker
Patients randomized to the A-CHESS group will receive the A-CHESS app on a smartphone.
干预措施: A-CHESS (Behavioral)
PartnerCHESS Drinker
Patients randomized to the PartnerCHESS group will receive all A-CHESS services listed above, plus learning modules and resources from Alcohol-based Couple Therapy.
干预措施: PartnerCHESS (Behavioral)
A-CHESS Partner
Patient's partner randomized to the A-CHESS group will receive the A-CHESS app on a smartphone.
干预措施: A-CHESS (Behavioral)
PartnerCHESS Partner
Patient's partner randomized to the PartnerCHESS group will receive all A-CHESS services listed above, plus learning modules and resources from Alcohol-based Couple Therapy.
干预措施: PartnerCHESS (Behavioral)
结局指标
主要结局
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.
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.
次要结局
- 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)
- 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)