Autonomous Digital CBT Intervention for Opioid Use Disorder in Individuals With Co-Occurring Internalizing Disorders
- Conditions
- AnxietyDepressionOpioid Use Disorder
- Interventions
- Behavioral: NEAT-O program
- Registration Number
- NCT06545071
- Lead Sponsor
- University of Minnesota
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 15
- 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
- Current diagnosis of psychosis
- Current institutionalization (e.g., jail, hospital)
- Self-reported pregnancy
- Non-English Speakers
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Study group NEAT-O program -
- Primary Outcome Measures
Name Time Method Usability 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 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 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).
- Secondary Outcome Measures
Name Time Method Preliminary Efficacy Indicators 45 days Patterns of opioid use (e.g., EMA data, Pre and Post-Tx measures), quality of life (WHODAS 2.0 scores), measures derived from the neurobiological domains of the addiction. These measures will be analyzed using descriptive and inferential statistics to identify early patterns and improvements.
Feasibility of EMA Collection Among Individuals with OUD 45 days Compliance with the EMA procedure will be assessed by tracking the number of days EMA prompts are completed as well as the average number of prompts completed per day using frequency counts and percentages.
Recruitment and Retention Metrics 45 days Recruitment effectiveness and participant retention will be monitored through descriptive statistics, including counts, percentages, and adherence rates to the recruitment timeline.