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临床试验/NCT05074030
NCT05074030
进行中(未招募)
不适用

Project CHOICE: Developing a Personalized-Feedback EMA/EMI Intervention for Emerging Adults Leaving Psychiatric Partial Hospitalization

Butler Hospital1 个研究点 分布在 1 个国家目标入组 60 人2023年2月6日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Alcohol Use Disorder
发起方
Butler Hospital
入组人数
60
试验地点
1
主要终点
Drinks per Drinking Days
状态
进行中(未招募)
最后更新
去年

概览

简要总结

The goal of this proposed study is to evaluate an ecological momentary assessment plus an ecological momentary intervention (EMA+EMI) for emerging adults in a psychiatric partial hospitalization program who drink to cope with negative affect (NA) as compared to personalized feedback only. This intervention combines a personalized feedback intervention (PFI) with EMA technology and tailored EMI text messaging (PFICope+EMI). PFICope+EMI not only aims to reduce drinking to cope, but also alcohol use and NA. This study consists of a 6-week randomized controlled treatment trial to test the PFIcope+EMI intervention as compared to personalized normative feedback only (PNF).

详细描述

Given the relationship between mental health and alcohol problems, there is a need to address comorbidity among emerging adults (EAs) with anxiety and/or depression. The weeks after psychiatric hospitalization are a risky time for problematic alcohol use and recurrence of psychiatric symptoms. The delivery of tailored, coping skills-based, real-time messages could have a significant impact on problematic drinking and depression/anxiety outcomes by reducing the likelihood that an individual drinks to cope with NA. The aim of this study is to test a 6-week PFIcope+EMI intervention as compared to personalized normative feedback only (PNF) for EA in a partial hospitalization program who drink to cope and binge drink (n=60). The PFIcope+EMI includes: 1) an in-person personalized feedback session to present feedback on problems with drinking to cope, discuss the individual's use of alcohol to cope, and generate coping skills messages to be used in the EMI intervention; 2) EMA to monitor affect, intention to drink, coping skills usage, alcohol use, drinking to cope post-discharge; 3) tailored text messages (EMI) based on EMA (individualized coping skills messages when NA and intention to drink are reported). The Personalized Normative Feedback condition (PNF) will receive a personalized normative feedback report but no EMA or EMI. Participants' alcohol outcomes and psychiatric symptomatology at 6-weeks, 12-weeks, and 6-months will be assessed to determine outcomes and feasibility/acceptability. It is hypothesized that: 1. Individuals in PFIcope+EMI arm will report between-subjects reductions in drinking to cope, alcohol use, alcohol-related problems, and NA as compared to PNF. 2. PFIcope+EMI will be feasible to implement and result in high rates of participant satisfaction. Mechanisms that may underlie the efficacy of the intervention for the PFIcope+EMI group utilizing the daily EMA data will be explored. It is hypothesized that: 1. In response to NA, participants will report an increase in coping skills utilization and decreased intent to drink at the following EMA assessment point. 2. NA reductions and increased coping skills utilization will be related to improvements in alcohol use rates and problems at the following EMA assessment.

注册库
clinicaltrials.gov
开始日期
2023年2月6日
结束日期
2025年10月1日
最后更新
去年
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • between 18 and 25 years of age
  • reported alcohol use at least 3x weekly over past month and at least one day per week, on average, of binge drinking (as defined as 4+ drinks/2 hours for men and 3+ drinks/2 hours for women)
  • self-reported use of coping motive (mean of 2+ on coping subscale of MDMQ-R, indicating they drink to cope at least "some of the time")
  • current anxiety and/or depression symptomatology (as assessed CES-D scores above cut-off for high risk for clinical depression and GAD-7 scores above cut-off for moderate to severe anxiety)
  • owns a smartphone capable of downloading EMA app.

排除标准

  • current DSM-5 diagnosis of moderate/severe substance use disorder (other than alcohol, cannabis, or nicotine) as assessed by research staff via SCID
  • a history of psychotic disorder or current psychotic symptoms as assessed by research staff via SCID
  • current suicidal/homicidal ideation.

结局指标

主要结局

Drinks per Drinking Days

时间窗: 6-week follow-up

Drinks per drinking day assessed using the Timeline Followback (TLFB)

次要结局

  • Drinking Motives(6-week follow-up)
  • Alcohol Outcome Expectancies(6-week follow-up)
  • Alcohol-related problems(6-week follow-up)

研究点 (1)

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