a randomized controlled trial of digital cbt to treat addiction: digital ritch®cbt vs. standard cbt

Conditions: Substance Use Disorders; Alcohol Use Disorder; Stimulant-Related Disorder

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.

we propose to conduct a feasibility study across years 1-2 in collaboration with fda's clinical data validation requirements to test the efficacy related endpoints of ritch®cbt by conducting a randomized trial. a total of 40 ethnically diverse male participants entering a substance abuse treatment facility, who meet current dsm-v criteria for substance dependence and have histories of ipv will be randomized to either "self-guided" 1:1 digital ritch®cbt therapy (n=20) or 1:1 standard cbt therapy (n=20, non-digitized, 1:1 talk cbt). each 60-minute session will occur 1x/week across 12 weeks of treatment. * primary outcomes will measure self-reported cravings via the auc/duc, number of days abstinent from substance use and number total days abstinent from aggression, both measured by the timeline follow-back method, with confirmation via breath samples, urine toxicology screens, and verified by collateral reports. * primary outcomes will be assessed at baseline, weekly through treatment, post-treatment, and at follow-ups 3, 6, and 9 months. * secondary outcome measures will be impulsivity and distress tolerance as measured by the barratt impulsiveness scale (bis) and response to conflict scale (rtc), respectively. * tertiary outcomes will be q-submissions, fda feedback on regulatory pathways and ide approval/confirmation of ide required filings across the protocol.

Eligibility 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).