A Randomized Controlled Trial of Digital CBT to Treat Addiction: Digital RITch®CBT vs. Standard CBT
2 other identifiers
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2023
CompletedFirst Posted
Study publicly available on registry
July 13, 2023
CompletedStudy Start
First participant enrolled
November 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
January 26, 2026
January 1, 2026
9 months
July 5, 2023
January 22, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Substance Use Cravings
Self-reported cravings across 84 days as measured by the AUC/DUC
84 days of treatment
Secondary Outcomes (1)
Substance Use
84 days
Study Arms (2)
Digital RITch®CBT
EXPERIMENTAL(Digital RITch®CBT) is a Digital Avatar Assisted Interactive CBT Treatment
Human Administered CBT
ACTIVE COMPARATORStandard CBT is a human administered CBT Treatment
Interventions
Digital treatment that deploys CBT.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Rochesterlead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
Strong Recovery - Part Of Strong Memorial Hospital
Rochester, New York, 14623, United States
Related Publications (1)
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.
PMID: 29108096BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
James Filingeri
University of Rochester
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Academic Division Chief of Addiction Psychiatry, Professor of Psychiatry, Director of Digital Therapeautics
Study Record Dates
First Submitted
July 5, 2023
First Posted
July 13, 2023
Study Start
November 27, 2025
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
August 31, 2026
Last Updated
January 26, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- 3-6 months after the study ends
- Access Criteria
- Caroline\ Easton@URMC.Rochester.Edu
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.