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临床试验/NCT07042451
NCT07042451招募中不适用

Digital Aftercare Assessed: An Evaluation of the Pink Cloud Application in Post-Treatment Substance Use Disorder Support

Loyola Marymount University2 个研究点 分布在 1 个国家目标入组 1,410 人开始时间: 2025年7月9日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
1,410
试验地点
2
主要终点
Change in sobriety status between baseline and 1 month

研究概览

简要总结

This randomized controlled trial (RCT) will evaluate the feasibility and efficacy of Pink Cloud, a mobile health application designed to support recovery from substance and alcohol use disorders (SUD/AUD). The app provides access to over 245,000 in-person and virtual 12-Step meetings, along with features such as a sobriety counter, daily planner, and personal inventory tools. In this study, 1,410 participants in various stages of recovery will be randomly assigned to receive either access to the Pink Cloud app or to a control condition. Participants will complete follow-up assessments at 1, 3, and 6 months. Primary outcomes include number of days sober and frequency of drug and alcohol problems. Secondary outcomes include meeting attendance, proportion of sober individuals in one's social network, and engagement in recovery-related activities. The investigators hypothesize that participants in the Pink Cloud group will report more days sober and fewer substance use problems than those in the control group, and that they will also report attending more meetings, having a greater proportion of sober peers, and engaging more frequently in recovery activities.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

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

  • Participant is 18 years of age or older
  • Participant is willing to attend a 12-Step or peer-to-peer recovery meeting (in person or virtual) within the next week
  • Participant owns a personal smartphone with cellular service
  • Participant is a permanent resident of the United States
  • Participant feels comfortable reading and understanding written English in everyday situations
  • Participant has consumed alcohol and/or used drugs (excluding tobacco or prescribed medication) at some point in their life, but not within the past couple of days
  • Participant is not currently attending outpatient or residential treatment for substance and/or alcohol use
  • Participant does not have a plan to enter substance and/or alcohol treatment in the next 30 days
  • Participant has been invited by the research team to either the intervention or control condition and redeemed their subscription code.
  • Informed consent is provided

排除标准

  • Participant is younger than 18 years of age
  • Participant is unwilling to attend a 12-Step or peer-to-peer recovery meeting (in person or virtual) within the next week
  • Participant does not own a personal smartphone with cellular service
  • Participant is not a permanent resident of the United States
  • Participant does not feel comfortable reading and understanding written English in everyday situations
  • Participant has consumed alcohol or used drugs (excluding tobacco or prescribed medication) within the past couple of days
  • Participant has never consumed alcohol or used drugs
  • Participant is currently attending outpatient or residential treatment for substance and/or alcohol use
  • Participant has a plan to enter substance and/or alcohol treatment in the next 30 days
  • Participant was not invited by the research team or did not redeem their assigned subscription code
  • Informed consent is not provided

结局指标

主要结局

Change in sobriety status between baseline and 1 month

时间窗: baseline, 1 month

Self-reported number of days participant reports not using alcohol or drugs in the past 30 days.

Change in sobriety status between baseline and 3 months

时间窗: baseline, 3 months

Self-reported number of days participant reports not using alcohol or drugs in the past 90 days.

Change in sobriety status between baseline and 6 months

时间窗: baseline, 6 months

Self-reported number of days participant reports not using alcohol or drugs in the past 180 days.

Change in alcohol and drug problems between baseline and 1 month

时间窗: baseline, 1 month

Self-reported frequency of alcohol and drugs problems in the past 30 days.

Change in alcohol and drug problems between baseline and 3 months

时间窗: baseline, 3 months

Self-reported frequency of alcohol and drugs problems in the past 90 days.

Change in alcohol and drug problems between baseline and 6 months

时间窗: baseline, 6 months

Self-reported frequency of alcohol and drugs problems in the past 180 days.

次要结局

  • Change in meeting attendance between baseline and 1 month(baseline, 1 month)
  • Change in meeting attendance between baseline and 3 months(baseline, 3 months)
  • Change in meeting attendance between baseline and 6 months(baseline, 6 months)
  • Change in social network between baseline and 1 month(baseline, 1 month)
  • Change in social network between baseline and 3 months(baseline, 3 months)
  • Change in social network between baseline and 6 months(baseline, 6 months)
  • Change in recovery related activities between baseline and 1 month(baseline, 1 month)
  • Change in recovery related activities between baseline and 3 months(baseline, 3 months)
  • Change in recovery related activities between baseline and 6 months(baseline, 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Joseph LaBrie

Principal Investigator

Loyola Marymount University

研究点 (2)

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