Digital RITch®CBT versus standard one-on-one CBT for men with substance use and partner aggression
A Randomized Controlled Trial of A Digital, Self-Guided, Avatar Assisted- Cognitive Behavioral Therapy Platform to Treat Addiction: RITch®CBT vs. Treatment As Usual
This trial will test whether a self-guided digital program called RITch®CBT helps men in addiction treatment who have recently shown aggression toward intimate partners, compared with standard one-on-one CBT.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Male |
| Sponsor | University of Rochester Academic / other |
| Locations | 1 site (Rochester, New York) |
| Trial ID | NCT05943171 on ClinicalTrials.gov |
What this trial studies
This randomized feasibility trial will enroll 40 men entering outpatient substance use treatment and who report recent intimate partner aggression, assigning 20 to self-guided digital RITch®CBT and 20 to standard face-to-face CBT, with weekly 60-minute sessions for 12 weeks. Primary outcomes include self-reported cravings (AUC/DUC), days abstinent from substance use, and days abstinent from aggression measured by Timeline Follow-Back and confirmed by breath, urine toxicology, and collateral reports, with assessments at baseline, weekly, post-treatment, and 3-, 6-, and 9-month follow-ups. Secondary outcomes measure impulsivity (BIS) and distress tolerance (RTC), and tertiary outcomes focus on FDA regulatory feedback and IDE-related submissions. If Phase I shows promise, a larger Phase II effectiveness trial (n≈160 total) is planned in collaboration with the FDA.
Who should consider this trial
Good fit: Men age 18–65 entering outpatient treatment who meet DSM‑5 criteria for substance dependence, used alcohol or stimulants in the prior 30 days, report recent verbal or physical aggression toward an intimate partner, and can read English at a sixth-grade level are ideal candidates.
Not a fit: People currently in acute withdrawal needing detox, those with significant cognitive impairment, psychomotor epilepsy, major neurologic conditions, or who are not male or cannot attend the Rochester site are unlikely to benefit from this specific trial.
Why it matters
Potential benefit: If effective, the digital program could make evidence-based CBT more convenient and widely available, potentially reducing cravings, substance use, and partner aggression.
How similar studies have performed: Digital CBT has shown benefits for some substance use problems in prior research, but combining a digital CBT approach specifically targeting co-occurring substance use and intimate partner aggression is relatively novel and not well established.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Rochester, New York
- Strong Recovery - Part Of Strong Memorial Hospital — Rochester, New York, United States (Recruiting)
Study contacts
- Study coordinator: Caroline J Easton, PhD
- Email: caroline_easton@urmc.rochester.edu
- Phone: 585-475-4065
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.