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

Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Study group
  • Behavioral: NEAT-O program
    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.

Recruiting Locations

More Details

Status
Recruiting
Sponsor
University of Minnesota

Study Contact

Justin Anker, Ph.D
612-625-7546
anke0022@umn.edu

If you are in crisis please dial 988 for the Suicide & Crisis Lifeline. Please note: ADAA is not a direct service organization. ADAA does not provide psychiatric, psychological, or medical advice, diagnosis, or treatment.
Donate Today Find a Therapist