Autonomous Digital CBT Intervention for Opioid Use Disorder in Individuals With Co-Occurring Internalizing Disorders - UG3
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Usability
研究概览
简要总结
The primary objective of this protocol is to implement the UG3 phase (Phase 1) of a National Institute on Drug Abuse (NIDA) UG3/UH3 grant (RFA-DA-23-049). This phase is dedicated to the pilot testing of NEAT-O, a digital Cognitive Behavioral Therapy (CBT) program tailored for individuals with opioid use disorder (OUD) and concurrent anxiety or mood disorders - collectively referred to as internalizing disorders (INTDs). NEAT-O is based on an empirically supported CBT framework, specifically modified to address the complexities of comorbidity in substance use disorders (SUDs). This pilot study will evaluate the usability and acceptability of NEAT-O in 15 participants with OUD, with the goal of refining the program's content and delivery methods. The results of the pilot study will inform a comprehensive RCT in the UH3 Phase (Phase 2) (N=300). Progression to the UH3 phase, with its funding, depends on meeting milestones in Phase 1 including demonstrating protocol adherence and the program's acceptability and usability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ages 18 to 65
- •Current DSM-5 diagnosis of OUD (confirmed during MINI 7 interview)
- •Current DSM-5 diagnosis of panic disorder with or without agoraphobia (PD/Ag) generalized anxiety disorder, social anxiety disorder, or major depression (confirmed during MINI 7 interview)
- •Currently in treatment for OUD using MOUD
- •Access to an internet-enabled smartphone for the duration of the study
- •Currently residing in the United States
- •Provision of informed consent
排除标准
- •Current diagnosis of psychosis
- •Current institutionalization (e.g., jail, hospital)
- •Self-reported pregnancy
- •Non-English Speakers
研究组 & 干预措施
Study group
干预措施: NEAT-O program (Behavioral)
结局指标
主要结局
Usability
时间窗: 45 days
Evaluated using the System Usability Scale (SUS) to assess effectiveness, efficiency, and satisfaction. The SUS is a well-validated questionnaire with 10 items. 27 Scores of 70 or above on the SUS are considered acceptable (Post-Tx).
Acceptability
时间窗: 45 days
Measured by the completion rate of NEAT-O modules, app usage frequency, modules accessed, and session length (after each module). Interaction frequency and module completion rates will be quantified using frequency counts and percentages.
Attractiveness and Information Quality
时间窗: 45 days
The Mobile Application Rating Scale (MARS) will be used to evaluate the attractiveness and information quality of NEAT-O. Scores of 3 or higher (out of a maximum score of 5) on the MARS are generally considered acceptable and indicate that the app has a high level of overall quality and content (after each module).
次要结局
- Preliminary Efficacy Indicators(45 days)
- Feasibility of EMA Collection Among Individuals with OUD(45 days)
- Recruitment and Retention Metrics(45 days)