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NCT05340738 · ClinicalTrials.gov registry record · NA

AI-Based Fidelity Feedback to Enhance CBT

A NA study of Cognitive Behavioral Therapy and Therapy, sponsored by University of Pennsylvania.

Recruiting
Registry status
NA
Development phase
425
Enrollment target
1
Study location

NCT05340738: Recruiting NA study of Cognitive Behavioral Therapy and Therapy, sponsored by University of Pennsylvania.

NCT05340738 is a NA study of Cognitive Behavioral Therapy and Therapy that is actively recruiting participants, run by University of Pennsylvania. The registered enrollment target is 425 participants, above the 135-participant average among 8 other Cognitive Behavioral Therapy trials with a reported enrollment target (215% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05340738, a NA study of Cognitive Behavioral Therapy and Therapy, is actively recruiting participants, sponsored by University of Pennsylvania.

RECRUITING
Registry status
NA
Development phase
425 participants
Enrollment target
1
Study location

Study 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,

Primary Outcome

CBT Fidelity will be assessed by AI-generated Cognitive Therapy Rating Scale (CTRS) scores for every recorded therapy session, which will be recorded via the Lyssn platform during both SAU and LyssnCBT phases of the study. CBT sessions are scored on different session components (agenda, feedback, understanding, etc.) with the CTRS on a scale of 0-6, from "poor" to "excellent", where higher scores indicate a greater degree of CBT fidelity. CTRS deviation scores will be created.Mean CTRS scores du

Interventions

  • OTHER LyssnCBT

Study Locations (1)

Pennsylvania

  • The Penn Collaborative for CBT and Implementation Science - Philadelphia

Trial Details

FieldValue
Enrollment Target 425 participants
Start Date 2023-03-09
Est. Completion 2026-01-31
Phase NA
University of Pennsylvania

1,423 total trials

What NCT05340738 shows while recruiting

NCT05340738 is an interventional study that assigns participants to a tested intervention. The registered 425 participants enrollment target is mid-sized for trials with a published cap, above the 135-participant average among 8 other Cognitive Behavioral Therapy trials with a reported enrollment target (215% higher).

The record links to 2 conditions, with Cognitive Behavioral Therapy appearing as the primary indexed condition, and to 1 intervention - of which LyssnCBT is the first listed.

NCT05340738 reports a single indexed study location in Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT05340738 about?

NCT05340738 is a clinical study titled "AI-Based Fidelity Feedback to Enhance CBT". 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 ...

What is the current status of trial NCT05340738?

This trial is currently recruiting. It is a NA study. The enrollment target is 425 participants. The study started on 2023-03-09. Estimated completion is 2026-01-31.

What conditions does trial NCT05340738 study?

This clinical trial studies the following conditions: Cognitive Behavioral Therapy, Therapy.

What interventions are being tested in trial NCT05340738?

The interventions under investigation include: LyssnCBT (OTHER).

Who is sponsoring clinical trial NCT05340738?

This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05340738 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Cognitive Behavioral Therapy

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05340738's enrollment target sits among peer trials

425 1st of 8 higher than 8 of 8 other Cognitive Behavioral Therapy trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Cognitive Behavioral Therapy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05340738, the US trial registry maintained by the National Library of Medicine. NCT05340738 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.