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

University of Rochester1 个研究点分布在 1 个国家目标入组 40 人2025年11月27日

适应症Substance Use Disorders Alcohol Use Disorder Stimulant-Related Disorder

干预措施Cognitive Behavioral Therapy Standard CBT

概览

阶段: 不适用
干预措施: Cognitive Behavioral Therapy
疾病 / 适应症: Substance Use Disorders
发起方: University of Rochester
入组人数: 40
试验地点: 1
主要终点: Substance Use Cravings
状态: 招募中
最后更新: 3个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

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.

详细描述

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.

注册库

clinicaltrials.gov

开始日期

2025年11月27日

结束日期

2026年8月31日

最后更新

3个月前

研究类型

Interventional

研究设计

Parallel

性别

Male

研究者

发起方

University of Rochester

责任方

Principal Investigator

主要研究者

Caroline Easton

Academic Division Chief of Addiction Psychiatry, Professor of Psychiatry, Director of Digital Therapeautics

University of Rochester

入排标准

入选标准

•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.

排除标准

•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).