An Evaluation of the Pink Cloud Application in Post- Treatment Substance Use Disorder Support

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое Pink Cloud
  Participants randomized to the Pink Cloud condition will receive a subscription code to access the Pink Cloud mobile application for approximately 365 days. The app includes features such as a searchable database of over 245,000 12-Step meetings (in-person and virtual), a sobriety counter, customizable daily planners, personal inventory tools, and a resentment journal. Participants are encouraged to use the app as they see fit throughout the study period. No prompts or required usage schedules w
• Поведенческое Active Control
  Participants randomized to the control condition will receive a code to access recovery-related resources hosted on a private study website. These materials include links to mutual-help groups, crisis support services, and educational content and treatment options. Participants may access the website at their discretion and engage with the resources as often and in whatever ways they choose. No prompts or required usage schedules will be imposed.

Первичные конечные точки

• Change in sobriety status between baseline and 1 month [Срок оценки: baseline, 1 month]
• Change in sobriety status between baseline and 3 months [Срок оценки: baseline, 3 months]
• Change in sobriety status between baseline and 6 months [Срок оценки: baseline, 6 months]
• Change in alcohol and drug problems between baseline and 1 month [Срок оценки: baseline, 1 month]
• Change in alcohol and drug problems between baseline and 3 months [Срок оценки: baseline, 3 months]
• Change in alcohol and drug problems between baseline and 6 months [Срок оценки: baseline, 6 months]

Вторичные конечные точки (9)

• Change in meeting attendance between baseline and 1 month [Срок оценки: baseline, 1 month]
• Change in meeting attendance between baseline and 3 months [Срок оценки: baseline, 3 months]
• Change in meeting attendance between baseline and 6 months [Срок оценки: baseline, 6 months]
• Change in social network between baseline and 1 month [Срок оценки: baseline, 1 month]
• Change in social network between baseline and 3 months [Срок оценки: baseline, 3 months]
• Change in social network between baseline and 6 months [Срок оценки: baseline, 6 months]
• Change in recovery related activities between baseline and 1 month [Срок оценки: baseline, 1 month]
• Change in recovery related activities between baseline and 3 months [Срок оценки: baseline, 3 months]
• Change in recovery related activities between baseline and 6 months [Срок оценки: baseline, 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Loyola Marymount — Los Angeles

Идентификаторы

NCT: NCT07042451 · R44DA061662

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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