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Life sciences · Interventional Study
ClinicalTrials.gov · October 26, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT05340738). This is a study registration, not published results. Lead sponsor: University of Pennsylvania. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 448 participants (ACTUAL). Conditions: Cognitive Behavioral Therapy, Therapy. Interventions: OTHER: LyssnCBT. Primary outcome measures: Change in therapist CBT fidelity as assessed by CTRS scores , Phase 2; Immediately after every recorded therapy session; Acceptability of LyssnCBT tools (Acceptability of Intervention Measure; AIM) , After three months of engagement with the LyssnCBT tools; Appropriateness of LyssnCBT tools (Intervention Appropriateness Measure; IAM) , Phase 2; Three months after the site moves from SAU to LyssnCBT; Feasibility of LyssnCBT tools (Feasibility of Intervention Measure; FIM) , Phase 2; Three months after the site moves from SAU to LyssnCBT; Usability of LyssnCBT tools (System Usability Scale; SUS) , Phase 2; Three months after the site moves from SAU to LyssnCBT; Change in client depression symptoms (Patient Health Questionnaire; PHQ-9) , Immediately before weekly therapy sessions for the duration of treatment or through study completion, a maximum of 18 months; Change in client anxiety symptoms (General Anxiety Disorder; GAD-7) , Immediately before weekly therapy sessions for the duration of treatment or through study completion, a maximum of 18 months; Client drop-out/premature termination from therapeutic engagement , Immediately before weekly therapy sessions for the duration of treatment or through study completion, a maximum of 18 months. Brief summary: This study is being conducted together by researchers at the University of Pennsylvania and Lyssn.io, Inc., ("Lyssn"), a technology start-up developing digital tools to support evidence-based psychotherapies (EBPs) for mental health disorders and addiction. This study will implement a technology to assess and enhance the quality of EBPs like Cognitive Behavioral Therapy (CBT) that includes a user interface geared to clinical, supervision, and administrative workflows and needs, and then assess this technology for effectiveness in comparison to usual care. There is a tremendous global burden of mental illness: Over 50 million American adults have a diagnosable mental health disorder, and major depression on its own is the leading cause of disability worldwide. In the face of this burden, clinical research has documented a variety of effective EBPs (e.g. CBT), and these psychotherapies are utilized on a massive scale. Systems have invested over $2 billion in training providers in specific EBPs. Once trained, however, therapists' adherence to the EBP, also called fidelity, is both crucial for effectiveness and difficult to assess. There is no scalable method to assess the fidelity and quality of EBPs in community practice settings. This is a foundational problem for healthcare systems. Advances in speech processing and machine learning make technology a promising solution to this problem. The use of technology - instead of humans - to evaluate EBPs means that objective, performance-based feedback can be provided quickly, efficiently, cost-effectively, and without human error. If successful, the present research will be among the first examples of a method for building, monitoring, and assessing the quality of therapy that can scale up to large, real-world healthcare settings. In this study, the investigators will implement an existing, fully-functional prototype (LyssnCBT) that includes a user interface geared to community mental health (CMH) clinical, supervision, and administrative workflows and needs, and then assess for effectiveness of psychotherapy supported by LyssnCBT in comparison to usual care. This study will implement LyssnCBT in 5 community mental health agencies, beginning with a single-arm pilot field trial to identify and address any specific barriers to implementing the tool in a community mental health context. The study team will then conduct a larger study in community mental health agencies comparing LyssnCBT to services as usual.