Digital RITch®CBT versus standard one-on-one CBT for men with substance use and partner aggression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.