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Идёт набор NCT07740395

Connecting Loved Ones to Support and Empowering Recovery

Без фазы С лечением Substance Use Disorder (SUD) mHealth

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: KulaMind-Recovery.
Кому может быть актуально
Состояния в реестре: Substance Use Disorder (SUD), mHealth. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Harnessing mHealth to Support Loved Ones of Individuals in Recovery From Substance Use Disorders

Обзор

Substance use disorders are highly prevalent. However, recovery from them is possible. The recovery process can benefit greatly from support from loved ones. Loved ones may need guidance in the most helpful ways to support recovery. This study aims to refine and test a web-based intervention, known as KulaMind-Recovery, which offers online skill building and educational modules, one-on-one video sessions and "on-demand" text-based support from a coach, and access to a community forum to connect with others with shared experience.

Подробное описание

Substance use disorders (SUDs) are one of the most prevalent chronic behavioral health issues in the United States and are responsible for significant morbidity and mortality. However, there is a high rate of recovery from SUDs. The loved ones of those in recovery can be an important source of support. Unfortunately, relationships are often strained by the chronic relapsing and remitting nature of SUDs, and SUD-related stigma may impede support from loved ones. Efforts to implement evidence-based interventions for loved ones have been hampered by a number of factors, including required specialized training for interventionists and the lengthy nature of the interventions. Efficacious and scalable interventions are therefore needed to guide the loved ones of those in recovery in evidence-based approaches to support the recovery process. mHealth facilitated interventions could be used to address these barriers, allowing for more efficient use of interventionist time through automation while maintaining "on demand" availability and the human touch that many find helpful. The goal of this project is to refine the KulaMind-Recovery Platform (KM-R), which is an AI-powered online program that aims to improve healthy family/social network behaviors and self- regulation skills of loved ones of those in recovery to strengthen the social support network. In addition to online skill building and educational modules, each loved one is matched with a coach who provides emotional support, accountability, and troubleshooting via group-based video sessions and "on demand" text-based support. Lastly, KM-R includes access to a community forum that allows loved ones to connect with others with shared experience. To accomplish our goal of refining this intervention, we will conduct an open label pilot study with 30 dyads (individual in early recovery and a loved one), in which the loved ones receive access to KM-R for 3 months, to examine the feasibility, acceptability, and preliminary signs of efficacy of the intervention.

Вмешательства

  • Поведенческое KulaMind-Recovery
    KulaMind-Recovery (KM-R) is an AI-powered web-based support platform that provides psychoeducation and training in evidenced-based cognitive behavioral skills and family interventions for substance use disorder. Loved ones will be matched with a human coach who will create a custom program of skills, psychoeducation materials, and other interventions. The coach will deliver these assignments through the AI digital tools on the KM-R platform, so loved ones can learn or practice skills at their co

Первичные конечные точки

  • Recovery Capital Score measured with the Assessment of Recovery Capital (ARC) [Срок оценки: Baseline & 3-Month Follow-up]
  • Substance Use Disorder-Related Stigma measured by the Stigma of Drug Users Scale [Срок оценки: Baseline & 3-Month Follow-up]
Вторичные конечные точки (4)
  • Satisfaction with the Relationship measured with the Relationship Assessment Scale [Срок оценки: Baseline & 3-Month Follow-up]
  • Substance use assessed with the Timeline Followback Interview [Срок оценки: Baseline & 3-Month Follow-up]
  • Knowledge Regarding Substance Use Disorders and their Treatment Assessed with a 20-Item Knowledge Inventory [Срок оценки: Baseline & 3-Month Follow-up]
  • Self-Efficacy to Support Recovery Measured with the Generalized Self-Efficacy Scale [Срок оценки: Baseline & 3-Month Follow-up]

Критерии участия

Inclusion Criteria for Individuals in Recovery:

  • 18+
  • have met criteria for a substance use disorder (with or without concomitant alcohol use disorder) in the past 24 months
  • have taken steps in the past 12 months to quit using drugs, cut down on drug use, or change the way in which they use drugs in order to improve the quality of their lives
  • willing to nominate a loved one to receive KulaMind-Recovery
  • have a loved one who is willing to participate in the study
  • able to understand and speak English and provide written and verbal consent

Inclusion Criteria for Loved Ones:

  • 18+
  • have a sustained relationship with the individual in recovery and are perceived to be an important person in the individual in recovery's life
  • do not provide professional substance use disorder-related services to the individual in recovery
  • have regular access to a device to engaged with KulaMind-Recovery
  • able to understand and speak English and provide written and verbal informed consent
  • do not endorse current (past month) suicidality

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Другое

Центры проведения

США · 1 центр
  • Rhode Island Hospital — Providence

Идентификаторы

NCT: NCT07740395 · 1R61DA064698-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗