COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Autonomous Digital CBT Intervention for Opioid Use Disorder in Individuals With Co-Occurring Internalizing Disorders - UG3

Quick Facts

Study Start:2025-08-21
Study Completion:2025-12-14
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06545071

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults ages 18 to 65
  2. * Current DSM-5 diagnosis of OUD (confirmed during MINI 7 interview)
  3. * 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)
  4. * Currently in treatment for OUD using MOUD
  5. * Access to an internet-enabled smartphone for the duration of the study
  6. * Currently residing in the United States
  7. * Provision of informed consent
  1. * Current diagnosis of psychosis
  2. * Current institutionalization (e.g., jail, hospital)
  3. * Self-reported pregnancy
  4. * Non-English Speakers

Contacts and Locations

Study Locations (Sites)

University of Minnesota
Minneapolis, Minnesota, 55455
United States

Collaborators and Investigators

Sponsor: University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-21
Study Completion Date2025-12-14

Study Record Updates

Study Start Date2025-08-21
Study Completion Date2025-12-14

Terms related to this study

Additional Relevant MeSH Terms

  • Opioid Use Disorder
  • Anxiety
  • Depression