Enhancing the quality of cognitive behavioral therapy in community mental health through artificial intelligence generated fidelity feedback (Project AFFECT): a study protocol.

Background: Each year, millions of Americans receive evidence-based psychotherapies (EBPs) like cognitive behavioral therapy (CBT) for the treatment of mental and behavioral health problems. Yet, at present, there is no scalable method for evaluating the quality of psychotherapy services, leaving EBP quality and effectiveness largely unmeasured and unknown. Project AFFECT will develop and evaluate an AI-based software system to automatically estimate CBT fidelity from a recording of a CBT session. Project AFFECT is an NIMH-funded research partnership between the Penn Collaborative for CBT and Implementation Science and Lyssn.io, Inc. ("Lyssn") a start-up developing AI-based technologies that are objective, scalable, and cost efficient, to support training, supervision, and quality assurance of EBPs. Lyssn provides HIPAA-compliant, cloud-based software for secure recording, sharing, and reviewing of therapy sessions, which includes AI-generated metrics for CBT. The proposed tool will build from and be integrated into this core platform.

Methods: Phase I will work from an existing software prototype to develop a LyssnCBT user interface geared to the needs of community mental health (CMH) agencies. Core activities include a user-centered design focus group and interviews with community mental health therapists, supervisors, and administrators to inform the design and development of LyssnCBT. LyssnCBT will be evaluated for usability and implementation readiness in a final stage of Phase I. Phase II will conduct a stepped-wedge, hybrid implementation-effectiveness randomized trial (N = 1,875 clients) to evaluate the effectiveness of LyssnCBT to improve therapist CBT skills and client outcomes and reduce client drop-out. Analyses will also examine the hypothesized mechanism of action underlying LyssnCBT.

Discussion: Successful execution will provide automated, scalable CBT fidelity feedback for the first time ever, supporting high-quality training, supervision, and quality assurance, and providing a core technology foundation that could support the quality delivery of a range of EBPs in the future.

Trial Registration: ClinicalTrials.gov; NCT05340738 ; approved 4/21/2022.