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

Part of paid clinical trials in Rochester, New York.

Sponsor
University of Rochester
Study ID
NCT05943171
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Cognitive Behavioral Therapy — DEVICE
    Digital treatment that deploys CBT.
  • Standard CBT — BEHAVIORAL
    Human Administered Manualized CBT

Study Details

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.

Key Dates

Start date
Nov 27, 2025
Status verified
Jan 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Digital RITch®CBT
    (Digital RITch®CBT) is a Digital Avatar Assisted Interactive CBT Treatment
  • Active Comparator: Human Administered CBT
    Standard CBT is a human administered CBT Treatment

Primary Outcome Measure

Substance Use Cravings [ Time Frame: 84 days of treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Strong Recovery - Part Of Strong Memorial HospitalRochesterNew York14623
Sage Garcia Agrait
[email protected]
Caroline Easton, PhD (PRINCIPAL_INVESTIGATOR)
Cory Crane, PhD (SUB_INVESTIGATOR)
Cassandra Berbary, PhD (SUB_INVESTIGATOR)

Find similar trials in Rochester, NY

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
Strong Recovery - Part Of Strong Memorial Hospital· Rochester, NY

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