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

NCT ID: NCT05943171

Last Updated: 2026-01-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-27
• Study Completion Date: 2026-08-31

Brief Summary

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.

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.

Conditions

Substance Use Disorders; Alcohol Use Disorder; Stimulant-Related Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Digital RITch®CBT

(Digital RITch®CBT) is a Digital Avatar Assisted Interactive CBT Treatment

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy

Intervention Type: DEVICE

Digital treatment that deploys CBT.

Human Administered CBT

Standard CBT is a human administered CBT Treatment

Group Type: ACTIVE_COMPARATOR

Standard CBT

Intervention Type: BEHAVIORAL

Human Administered Manualized CBT

Interventions

Cognitive Behavioral Therapy

Digital treatment that deploys CBT.

Intervention Type: DEVICE

Standard CBT

Human Administered Manualized CBT

Intervention Type: BEHAVIORAL

Other Intervention Names

Device (Digital RITch®CBT)

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Caroline Easton

Academic Division Chief of Addiction Psychiatry, Professor of Psychiatry, Director of Digital Therapeautics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James Filingeri

Role: STUDY_CHAIR

University of Rochester

Locations

Strong Recovery - Part Of Strong Memorial Hospital

Rochester, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Caroline J Easton, PhD

Role: CONTACT

caroline_easton@urmc.rochester.edu

585-475-4065

Cory Crane, PhD

Role: CONTACT

cory_crane@urmc.rochester.edu

585-

Facility Contacts

Sage Garcia Agrait

Role: primary

Sage_GarciaAgrait@urmc.rochester.edu

References

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.

Reference Type: BACKGROUND

PMID: 29108096 (View on PubMed)

Other Identifiers

7UG3DA057042-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00010815

Identifier Type: -

Identifier Source: org_study_id