A Randomized Controlled Trial of Digital CBT to Treat Addiction: Digital RITch®CBT vs. Standard CBT

A Randomized Controlled Trial of A Digital, Self-Guided, Avatar Assisted- Cognitive Behavioral Therapy Platform to Treat Addiction: RITch®CBT vs. Treatment As Usual

Substance Use Disorders continue to increase across the United States with significant adverse effects resulting in more than $700 billion annually (NIDA, 2017) with high co-occurring rates of IPV. The negative consequences are devastating to families and society. This team has developed a digital, interactive platform, RITch®CBT for the convenience of participants' within their own home & with out of session practice exercises. We propose to conduct a Phase I and II Study: UG3 (Phase I) and UH3 (Phase II) in collaboration with the FDA regarding ongoing feedback and regulatory processes. In Phase I, we propose a feasibility study, a randomized controlled trial to test the efficacy of RITch®CBT (n=20) among SUD-IPV diverse male clients entering addiction treatment comparing it to face to face 1:1 CBT (TAU, n=20). If efficacious, a Phase II (UH3, n=80) trial will be conducted to test the effectiveness of RITch®CBT among SUD-IPV compared to TAU (n=80) in reducing addiction and IPV.

Study Overview

• Status: Recruiting
• Conditions: Substance Use Disorders; Alcohol Use Disorder; Stimulant-Related Disorder
• Intervention / Treatment: Device: Cognitive Behavioral Therapy; Behavioral: Standard CBT

Detailed Description

We propose to conduct a feasibility study across years 1-2 in collaboration with FDA's clinical data validation requirements to test the efficacy related endpoints of RITch®CBT by conducting a randomized trial. A total of 40 ethnically diverse male participants entering a substance abuse treatment facility, who meet current DSM-V criteria for substance dependence and have histories of IPV will be randomized to either "self-guided" 1:1 digital RITch®CBT Therapy (n=20) or 1:1 Standard CBT Therapy (n=20, non-digitized, 1:1 talk CBT). Each 60-minute session will occur 1x/week across 12 weeks of treatment.

• Primary outcomes will measure self-reported cravings via the AUC/DUC, number of days abstinent from substance use and number total days abstinent from aggression, both measured by the Timeline Follow-Back method, with confirmation via breath samples, urine toxicology screens, and verified by collateral reports.
• Primary Outcomes will be assessed at baseline, weekly through treatment, post-treatment, and at follow-ups 3, 6, and 9 months.
• Secondary outcome measures will be impulsivity and distress tolerance as measured by the Barratt Impulsiveness Scale (BIS) and Response to Conflict Scale (RTC), respectively.
• Tertiary outcomes will be Q-submissions, FDA feedback on regulatory pathways and IDE approval/confirmation of IDE required filings across the protocol.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Caroline J Easton, PhD; Phone Number: 585-475-4065; Email: caroline_easton@urmc.rochester.edu
• Study Contact Backup: Name: Cory Crane, PhD; Phone Number: 585-; Email: cory_crane@urmc.rochester.edu

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14623
      • Recruiting
      • Strong Recovery - Part Of Strong Memorial Hospital
      • Contact: Sage Garcia Agrait; Email: Sage_GarciaAgrait@urmc.rochester.edu
      • Principal Investigator: Caroline Easton, PhD
      • Sub-Investigator: Cory Crane, PhD
      • Sub-Investigator: Cassandra Berbary, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Participants between the ages of 18-65 will be 40 men entering outpatient treatment who

(1) meet current DSM-V criteria substance dependence (and use alcohol and/or stimulants within the 30 days prior to the screening session); (2) report verbal aggression, conflict/aggression in a current intimate relationship (e.g., yelling, screaming, pushing, slapping) within 30 days prior to screening; and (3) can read English at a 6th grade level.

Exclusion Criteria:

Participants will be excluded if they: 1) Are currently in withdrawal from substance and in need of detoxification (such individuals may be re-evaluated following detoxification); 2) Have cognitive impairment (a mini mental state score <25); 3) Have psychomotor epilepsy (e.g. impulsivity or rage related symptoms secondary to a seizure disorder, as this medical diagnosis is likely to be a confound in the proposed study); 4) Have major medical complications such as a head injury/trauma, or HIV dementia that may also be a confound in the study interventions; 5) Are currently receiving either substance abuse or IPV treatment elsewhere; 6.) Have a lifetime history of any psychotic or bipolar disorder; or 7) Are currently suicidal or homicidal or 8) severe violence (punching, chocking, use of weapons).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digital RITch®CBT; (Digital RITch®CBT) is a Digital Avatar Assisted Interactive CBT Treatment	Device: Cognitive Behavioral Therapy; Digital treatment that deploys CBT.; Other Names: Device (Digital RITch®CBT)
Active Comparator: Human Administered CBT; Standard CBT is a human administered CBT Treatment	Behavioral: Standard CBT; Human Administered Manualized CBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Substance Use Cravings	Self-reported cravings across 84 days as measured by the AUC/DUC	84 days of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Substance Use	Self report substance use across 84 days as measured by the Timeline Follow Back and verified by objective indicators of substance use (breathalyzer and urine toxicology screens)	84 days

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Study Chair: James Filingeri, University of Rochester

Publications and helpful links

General Publications

• Easton CJ, Crane CA, Mandel D. A Randomized Controlled Trial Assessing the Efficacy of Cognitive Behavioral Therapy for Substance-Dependent Domestic Violence Offenders: An Integrated Substance Abuse-Domestic Violence Treatment Approach (SADV). J Marital Fam Ther. 2018 Jul;44(3):483-498. doi: 10.1111/jmft.12260. Epub 2017 Nov 6.

Helpful Links

• Addiction Violence Research with Digital Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: July 5, 2023
• First Submitted That Met QC Criteria: July 5, 2023
• First Posted (Actual): July 13, 2023

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Alcoholism; Substance-Related Disorders
• Other Study ID Numbers: STUDY00010815; 7UG3DA057042-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The proposed research may result in new technologies and methodologies to treat SUD and IPV. Since this study is a Phase I and II trial, and if results show that RITch®CBT is more effective than TAU in reducing Addiction and IPV, the data are intended to prepare this investigative team for a larger trial through dissemination across multiple sites. The data may also be applicable and useful to the community, the approaches and key results. Should there be requests for the raw datasets, these will be considered and we will be careful to review with our IRB and RRH CD clinic to ensure there is no possibility of violating the rights of any participants.
• IPD Sharing Time Frame: 3-6 months after the study ends
• IPD Sharing Access Criteria: Caroline_Easton@URMC.Rochester.Edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No