Actively Recruiting
Led by University of Rochester · Updated on 2026-01-26
40
Participants Needed
1
Research Sites
N/A
Total Duration
U
University of Rochester
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
Researchers are evaluating a digital, interactive platform called RITch CBT designed to treat Substance Use Disorders (SUD) and co-occurring Intimate Partner Violence (IPV) in men entering addiction treatment. This Phase I and II study involves a randomized controlled trial to compare the digital RITch CBT with standard one-on-one face-to-face Cognitive Behavioral Therapy (CBT). The study aims to explore the feasibility and effectiveness of this digital therapy approach in reducing both addiction and IPV behaviors among a diverse male population. The study will enroll 40 male participants diagnosed with substance dependence and recent IPV behaviors, randomly assigned to either digital RITch CBT or standard CBT groups. Each therapy consists of weekly 60-minute sessions over 12 weeks. The digital RITch CBT uses an avatar-assisted interactive approach allowing participants to engage conveniently from home with practice exercises outside sessions. The standard CBT involves manualized, human-administered treatment. If Phase I shows positive results, a larger Phase II trial with 160 participants will follow to further test effectiveness. Participants will undergo multiple assessments including self-reported cravings, days abstinent from substance use and aggression, breath and urine tests to confirm abstinence, and reports from collateral sources. Primary outcomes are measured weekly during treatment and at follow-ups 3, 6, and 9 months post-treatment. Secondary outcomes include impulsivity and distress tolerance scales, while additional data involve regulatory feedback and submissions. The total participant involvement spans screening, 12 weeks of treatment, and extended follow-ups to monitor progress and safety.
CONDITIONS
A Randomized Controlled Trial of Digital CBT to Treat Addiction: Digital RITch®CBT vs. Standard CBT
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive either a digital avatar assisted interactive CBT treatment or a human administered standard CBT treatment to address substance dependence and related aggression.
Weekly visits for 12 weeks, each lasting 60 minutes
Duration - 9 months
Participants are monitored at 3, 6, and 9 months after treatment to assess substance use cravings, abstinence, and related outcomes.
3 visits (at 3, 6, and 9 months post-treatment)
Total: 1 location
1
Strong Recovery - Part Of Strong Memorial Hospital
Rochester, New York, United States, 14623
Actively Recruiting
C
Caroline J Easton, PhD
C
Cory Crane, PhD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Caroline J Easton, Cory A Crane, Dolores Mandel
https://pubmed.ncbi.nlm.nih.gov/29108096