Leveraging mHealth to Promote Opioid Use Recovery and Mental Health Among Residents of a Medium-Sized Midwestern City
2026年6月22日 更新者：Washington University School of Medicine
Leveraging mHealth to Promote Recovery From Opioid Use Disorder and Commonly Occurring Mental Health Disorders Among Residents of a Medium-Sized Midwestern City
The sequential trial compares recovery and mHealth engagement outcomes among Black participants who participated in the mHealth intervention uMAT-R or uMAT-R + enhanced community engagement.
The mHealth intervention seeks to support people in various stages of recovery who are also seeking other forms of substance use treatment.
Participants are recruited from community-based substance use treatment facilities and recovery services.
Participants must be adults who have or are currently using opioids and/or stimulants.
研究概览
地位
招聘中
研究类型
介入性
注册 (估计的)
300
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Hannah Szlyk
- 电话号码：917-836-4225
- 邮箱：szlyk@wustl.edu
研究联系人备份
- 姓名：Elecia Worley
- 邮箱：e.m.worley@wustl.edu
学习地点
-
-
Missouri
-
St Louis、Missouri、美国、63110
- 招聘中
- Washington University School of Medicine
-
接触：
- Hannah Szlyk, PhD
- 电话号码：917-836-4225
- 邮箱：szlyk@wustl.edu
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Have a history of opioid and/or stimulant use
- Identify as Black and/or African American
- Seek treatment at local substance use treatment centers
- Fluent in English
- U.S. resident
- 18 years of age or older at the time of data collection.
Exclusion Criteria:
- Self-reported cognitive impairment that would limit ability to participate in research.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：非随机化
- 介入模型：顺序分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：uMAT-R + enhanced community engagement
uMAT-R + enhanced community engagement involves an optimized community engagement strategy employed by the intervention team.
|
uMAT-R + enhanced community engagement involves an optimized community engagement strategy employed by the intervention team.
This involves in-person interactions with eligible participants and recruitment sites.
|
|
有源比较器：Original uMAT-R supplementary mHealth recovery intervention
uMAT-R supplementary mHealth recovery intervention is the original intervention disseminated without optimization of the community engagement approach.
|
uMAT-R supplementary mHealth recovery intervention is the original intervention without optimization of the community engagement approach.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Abstinence/ Changes in Substance Use
大体时间：Time 0 (Baseline) and Time 1 (One Month)
|
Frequency of opioid use, stimulant, and/or other substance use (e.g., discordant with prescribed usage) or other substances (e.g., stimulants, other non-opioid illicit drugs) in the past 30-day will be assessed by items from the National Survey on Drug Use and Health (NSDUH) questionnaire.
The score indicates days on using any substance listed above over past 30-day, ranging from 0 to 30, with a higher score reflecting more frequent substance use.
|
Time 0 (Baseline) and Time 1 (One Month)
|
|
Opioid use/ Stimulant use disorder symptoms
大体时间：Time 0 (Baseline) and Time 1 (One Month)
|
The number of DSM-5-TR diagnostic criteria met for opioid use disorder (OUD) and stimulant use disorder (StUD) will be assessed.
Scores range from 0 to 11, with higher scores indicating that more diagnostic criteria are met for the disorder.
|
Time 0 (Baseline) and Time 1 (One Month)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Depression symptoms
大体时间：Time 0 (Baseline) and Time 1 (One-Month)
|
The Patient Health Questionnaire-9 (PHQ-9) will be used to assess depression symptoms.
The potential scale scores range from 0 to 27, with higher scores indicating more severe depressive symptoms.
Continuous variables will be created to assess the total scores at baseline and the 1-month follow-up, respectively.
|
Time 0 (Baseline) and Time 1 (One-Month)
|
|
Anxiety Symptoms
大体时间：Time 0 (Baseline) and Time 1 (One-Month)
|
The Generalized Anxiety Disorder Assessment-7 (GAD-7) will be used to assess anxiety symptoms.
Each item is scored on a scale of 0 (not at all) to 3 (nearly every day), allowing for a comprehensive evaluation of anxiety symptoms in the past 2 weeks, such as 'Feeling nervous, anxious, or on edge' or 'Becoming easily annoyed or irritable...' The potential scale scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms.
To examine the changes in GAD-7 scores from baseline to the 1-month follow-up, continuous variables will be created to assess the scores at the respective time points.
|
Time 0 (Baseline) and Time 1 (One-Month)
|
|
Basic needs
大体时间：Time 0 (Baseline) and Time 1 (One-Month)
|
The adapted Wellbeing and Basic Needs Survey will be used to assess confidence in meeting their basic needs.
Participants were asked to rate their confidence in meeting their basic needs on a Likert scale ranging from "very confident" (1) to "not confident at all" (8).
To examine changes in scores continuous variables were created to capture the baseline and 1-month follow-up scores, respectively.
Scores may range from 8 to 64, which higher scores indicating less confidence in attending to basic needs.
|
Time 0 (Baseline) and Time 1 (One-Month)
|
|
Medication for Opioid Use Disorder (MOUD) Attitudes
大体时间：Time 0 (Baseline), and Time 1 (One-Month)
|
We will measure Medication for Opioid Use Disorder (MOUD) attitudes using an 8-item subscale to evaluate participants' attitudes towards MOUD modified from the Attitudes of Methadone Scale.
Participants will provide responses on a 5-point Likert scale, ranging from 'strongly disagree' (1) to 'strongly agree' (5).
Sample items include: 'Taking MOUD is only replacing one addiction with another,' 'A person is better off taking MOUD than opioids,' and 'MOUD is as dangerous as opioids.'
The total score will be calculated by summing all items, resulting in a potential scoring range of 8 to 40 with higher scores indicating greater negative attitudes toward MOUD use.
|
Time 0 (Baseline), and Time 1 (One-Month)
|
|
Substance Use Disorder (SUD) Treatment Engagement
大体时间：Time 0 (Baseline), and Time 1 (One-Month)
|
Participants will be asked if they are enrolled and receive specialty substance use care, and/or medication for Opioid Use Disorder, assessed by self-report. "Are you currently enrolled in a treatment plan or program for substance use care?" "Are you currently being prescribed medication for opioid use disorder (MOUD)" Response options will include "yes" or "no." If a participant responds "yes" to at least one question, the final outcome for substance use treatment engagement will be coded as "yes." "No" responses to both questions will be coded as "No." |
Time 0 (Baseline), and Time 1 (One-Month)
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Client/User Experience
大体时间：Time 1 (One-Month)
|
Participants discuss ease of use and learning, usefulness, and likability of using uMAT-R, and their overall experience pursuing substance use recovery.
|
Time 1 (One-Month)
|
|
uMAT-R App Engagement
大体时间：From Time 0 to Time 1
|
Participants who logged into the mobile app 1 or more times during the 1 month intervention will be considered engaged in the app.
The outcome will be binary (yes/no).
|
From Time 0 to Time 1
|
|
uMAT-R E-coach Engagement
大体时间：Time 0 to Time 1
|
Will be assessed by whether participants sent at least one message to the e-coach and the outcome will be binary (yes/no).
|
Time 0 to Time 1
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年8月31日
初级完成 (估计的)
2026年12月31日
研究完成 (估计的)
2027年2月28日
研究注册日期
首次提交
2026年6月17日
首先提交符合 QC 标准的
2026年6月22日
首次发布 (实际的)
2026年6月29日
研究记录更新
最后更新发布 (实际的)
2026年6月29日
上次提交的符合 QC 标准的更新
2026年6月22日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.