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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

Tracking Information
First Submitted Date  ICMJE July 5, 2023
First Posted Date  ICMJE July 13, 2023
Last Update Posted Date July 13, 2023
Estimated Study Start Date  ICMJE September 1, 2023
Estimated Primary Completion Date May 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2023)		 Substance Use Cravings [ Time Frame: 84 days of treatment ]
Self-reported cravings across 84 days as measured by the AUC/DUC
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2023)		 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized Controlled Trial of Digital CBT to Treat Addiction: Digital RITch®CBT vs. Standard CBT
Official Title  ICMJE A Randomized Controlled Trial of A Digital, Self-Guided, Avatar Assisted- Cognitive Behavioral Therapy Platform to Treat Addiction: RITch®CBT vs. Treatment As Usual
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Substance Use Disorders
  • Alcohol Use Disorder
  • Stimulant-Related Disorder
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: Digital RITch®CBT
    (Digital RITch®CBT) is a Digital Avatar Assisted Interactive CBT Treatment
    Intervention: Device: Cognitive Behavioral Therapy
  • Active Comparator: Standard CBT
    Standard CBT is a human administered CBT Treatment
    Intervention: Device: Cognitive Behavioral Therapy
Publications * Easton CJ, Crane CA, Mandel D. A Randomized Controlled Trial Assessing the Efficacy of Cognitive Behavioral Therapy for Substance-Dependent Domestic Violence Offenders: An Integrated Substance Abuse-Domestic Violence Treatment Approach (SADV). J Marital Fam Ther. 2018 Jul;44(3):483-498. doi: 10.1111/jmft.12260. Epub 2017 Nov 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 5, 2023)		 40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2024
Estimated Primary Completion Date May 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Caroline J Easton, PhD 585-475-4065 caroline.easton@rit.edu
Contact: Cory Crane, PhD 585-475-4018 cacihst@rit.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05943171
Other Study ID Numbers  ICMJE UG3DA057042( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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
Current Responsible Party Dr. Caroline Easton, Rochester Institute of Technology
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Rochester Institute of Technology
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Heather Foti, MS Rochester Institute of Technology
PRS Account Rochester Institute of Technology
Verification Date July 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP