Autonomous Digital CBT Intervention for Opioid Use Disorder in Individuals With Co-Occurring Internalizing Disorders

NCT06545071 | Active Not Recruiting Phase 1

• 2 other identifiers: 32774UG3DA059414
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use Disorder; Anxiety; Depression

Outcome Measures

Primary Outcomes (3)

• Acceptability

  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.

  45 days

• Usability

  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).

  45 days

• Attractiveness and Information Quality

  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).

  45 days

Secondary Outcomes (3)

• Feasibility of EMA Collection Among Individuals with OUD

  45 days

• Recruitment and Retention Metrics

  45 days

• Preliminary Efficacy Indicators

  45 days

Study Arms (1)

Study group

EXPERIMENTAL

Behavioral: NEAT-O program

Interventions

NEAT-O program BEHAVIORAL

NEAT-O's curriculum is designed to interrupt the cycle of negative emotions and opioid use through a multifaceted approach encompassing physiological, psychological, and behavioral strategies. The program includes interactive modules that capture the core therapeutic components of CBT and teach skills to support OUD recovery.

Study group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Current diagnosis of psychosis
• Current institutionalization (e.g., jail, hospital)
• Self-reported pregnancy
• Non-English Speakers

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 9, 2024
• Study Start: August 21, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

US (1)