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.
調査の概要
状態
募集
研究の種類
介入
入学 (推定)
300
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Hannah Szlyk
- 電話番号：917-836-4225
- メール：szlyk@wustl.edu
研究連絡先のバックアップ
- 名前：Elecia Worley
- メール：e.m.worley@wustl.edu
研究場所
-
-
Missouri
-
St Louis、Missouri、アメリカ、63110
- 募集
- Washington University School of Medicine
-
コンタクト：
- Hannah Szlyk, PhD
- 電話番号：917-836-4225
- メール：szlyk@wustl.edu
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：非ランダム化
- 介入モデル：順次割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
アクティブコンパレータ：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Abstinence/ Changes in Substance Use
時間枠：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
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Depression symptoms
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Client/User Experience
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2025年8月31日
一次修了 (推定)
2026年12月31日
研究の完了 (推定)
2027年2月28日
試験登録日
最初に提出
2026年6月17日
QC基準を満たした最初の提出物
2026年6月22日
最初の投稿 (実際)
2026年6月29日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月29日
QC基準を満たした最後の更新が送信されました
2026年6月22日
最終確認日
2026年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。