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临床试验/NCT05074030
NCT05074030已完成不适用

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

Butler Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年2月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Drinks per Drinking Days

研究概览

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:

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 25 Years(Adult)
性别
All
接受健康志愿者

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.

研究组 & 干预措施

Personalized Normative Feedback (PNF)

Active Comparator

Participants in the PNF condition will receive normative feedback only on their alcohol use.

干预措施: Personalized Normative Feedback (Behavioral)

PFIcope+EMI

Experimental

The 6-week 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).

干预措施: Coping-Motive Specific Personalized Feedback Intervention plus an Ecological Momentary Intervention (PFIcope+EMI) (Behavioral)

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)

Drinks Per Drinking Day

时间窗: 6-week follow-up

Drinks per drinking day assessed using the Addiction Severity Index

次要结局

  • Drinking Motives(6-week follow-up)
  • Alcohol Outcome Expectancies(6-week follow-up)
  • Alcohol-related problems(6-week follow-up)
  • Anxiety Coping Drinking Motives(6-week follow-up)
  • Depression Coping Drinking Motives(6-weeks)
  • Positive Alcohol Outcome Expectancies(6-week follow-up)
  • Negative Alcohol Expectancies(6-weeks)
  • Alcohol-related Problems(6-week follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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