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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Controlled Trial of A Digital, Self-Guided, Avatar Assisted- Cognitive Behavioral Therapy Platform to Treat Addiction: RITch®CBT vs. Treatment As Usual

Conditions
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Substance Use Disorders, Alcohol Use Disorder, Stimulant-Related Disorder

Intervention / Treatment
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* Device: Cognitive Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Randomized to either Digital Avatar Assisted CBT or Human Administered CBT
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digital RITch®CBT<br>(Digital RITch®CBT) is a Digital Avatar Assisted Interactive CBT Treatment | Device: Cognitive Behavioral Therapy<br>* All participants will receive Cognitive Behavioral Therapy. They will be randomized to either Digital RITch®CBT or Standard CBT<br>* Other names: Standard CBT;|
| Active Comparator: Standard CBT<br>Standard CBT is a human administered CBT Treatment | Device: Cognitive Behavioral Therapy<br>* All participants will receive Cognitive Behavioral Therapy. They will be randomized to either Digital RITch®CBT or Standard CBT<br>* Other names: Standard CBT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Substance Use Cravings | Self-reported cravings across 84 days as measured by the AUC/DUC | 84 days of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Substance Use | Self report substance use across 84 days as measured by the Timeline Follow Back and verified by objective indicators of substance use (breathalyzer and urine toxicology screens) | 84 days |