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

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ClinicalTrials.gov Identifier: NCT05943171
Recruitment Status : Not yet recruiting
First Posted : July 13, 2023
Last Update Posted : July 13, 2023
Sponsor:
Information provided by (Responsible Party):
Dr. Caroline Easton, Rochester Institute of Technology

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Substance Use Disorders Alcohol Use Disorder Stimulant-Related Disorder Device: Cognitive Behavioral Therapy Not Applicable

Detailed Description:

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Randomized to either Digital Avatar Assisted CBT or Human Administered CBT
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of A Digital, Self-Guided, Avatar Assisted- Cognitive Behavioral Therapy Platform to Treat Addiction: RITch®CBT vs. Treatment As Usual
Estimated Study Start Date : September 1, 2023
Estimated Primary Completion Date : May 1, 2024
Estimated Study Completion Date : August 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Digital RITch®CBT
(Digital RITch®CBT) is a Digital Avatar Assisted Interactive CBT Treatment
 Device: Cognitive Behavioral Therapy
All participants will receive Cognitive Behavioral Therapy. They will be randomized to either Digital RITch®CBT or Standard CBT
Other Names:
  • Device (Digital RITch®CBT)
  • Standard CBT
Active Comparator: Standard CBT
Standard CBT is a human administered CBT Treatment
 Device: Cognitive Behavioral Therapy
All participants will receive Cognitive Behavioral Therapy. They will be randomized to either Digital RITch®CBT or Standard CBT
Other Names:
  • Device (Digital RITch®CBT)
  • Standard CBT


Outcome Measures
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Primary Outcome Measures :
  1. Substance Use Cravings [ Time Frame: 84 days of treatment ]
    Self-reported cravings across 84 days as measured by the AUC/DUC


Secondary Outcome Measures :
  1. Substance Use [ Time Frame: 84 days ]
    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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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).

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05943171


Contacts
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Contact: Caroline J Easton, PhD 585-475-4065 caroline.easton@rit.edu
Contact: Cory Crane, PhD 585-475-4018 cacihst@rit.edu

Sponsors and Collaborators
Rochester Institute of Technology
Investigators
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Study Chair: Heather Foti, MS Rochester Institute of Technology
More Information
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Publications:

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Responsible Party: Dr. Caroline Easton, Principal Investigator, Rochester Institute of Technology
ClinicalTrials.gov Identifier: NCT05943171    
Other Study ID Numbers: UG3DA057042 ( U.S. NIH Grant/Contract )
First Posted: July 13, 2023    Key Record Dates
Last Update Posted: July 13, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The proposed research may result in new technologies and methodologies to treat SUD and IPV. Since this study is a Phase I and II trial, and if results show that RITch®CBT is more effective than TAU in reducing Addiction and IPV, the data are intended to prepare this investigative team for a larger trial through dissemination across multiple sites. The data may also be applicable and useful to the community, the approaches and key results. Should there be requests for the raw datasets, these will be considered and we will be careful to review with our IRB and RRH CD clinic to ensure there is no possibility of violating the rights of any participants.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 3-6 months after the study ends
Access Criteria: Caroline.Easton@Rit.Edu
URL: http://www.rit.edu/favtech/contact-us

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Substance-Related Disorders
Alcoholism
Chemically-Induced Disorders
Mental Disorders
Alcohol-Related Disorders