AI-Based CBT Enhancement for Mental Health

(AFFECT Trial)

Overseen By Ana DeCesare, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Unwilling to share recordings

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

425 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a digital tool called LyssnCBT to improve the quality of Cognitive Behavioral Therapy (CBT) for mental health treatments. The researchers aim to determine if this technology can help therapists deliver better therapy compared to usual care. The tool uses AI to provide feedback on therapy sessions, eliminating human error and making the process faster and more cost-effective. Suitable participants are those receiving therapy in English at community mental health centers in Philadelphia and willing to have their session recordings used for research. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance therapy quality for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on therapy sessions rather than medication use.

What prior data suggests that this technology is safe for enhancing mental health treatments?

Research shows that the digital tool LyssnCBT helps therapists by providing real-time feedback during therapy sessions. This tool uses AI to assist therapists in refining their methods and ensuring adherence to proven techniques.

While detailed safety information about LyssnCBT is not available, it is important to note that this tool is neither a medication nor a medical device. Instead, it supports therapists by offering insights into their sessions, with no known side effects directly linked to its use.

The tool has been tested in community mental health settings, demonstrating its practicality and non-disruptive nature for both therapists and clients. As the study is in an early phase, more information on potential issues may emerge, but no major problems have been reported so far. In short, LyssnCBT aims to enhance therapy without introducing new risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about LyssnCBT because it leverages AI to enhance cognitive behavioral therapy (CBT) sessions. Unlike traditional CBT, LyssnCBT offers real-time tools such as speech-to-text transcription, annotation, and AI-generated metrics, empowering therapists with immediate insights and feedback. These features can potentially make therapy sessions more efficient and tailored to individual client needs, leading to improved mental health outcomes.

What evidence suggests that the LyssnCBT tool is effective for enhancing the quality of Cognitive Behavioral Therapy?

Research has shown that the LyssnCBT tool can enhance the quality of Cognitive Behavioral Therapy (CBT) by using artificial intelligence to assess how well therapists adhere to proven methods. In this trial, one group of therapists will use the full LyssnCBT tool, which includes features like speech-to-text transcription, annotation tools, and AI-generated metrics, to improve therapy outcomes by providing feedback on their performance. Another group will use the LyssnCBT tool only for recording and session-sharing functionalities, without access to additional features. The tool reviews recorded therapy sessions and offers tips for therapist improvement, which is crucial for effective therapy. This technology aims to make therapy more consistent and effective on a large scale by ensuring therapists follow best practices. ^{1 3 4 5 6}

Who Is on the Research Team?

Torrey A Creed, PhD

Principal Investigator

Director, The Penn Collaborative for CBT and Implementation Science

David Atkins, PhD

Principal Investigator

CEO, Lyssn

Are You a Good Fit for This Trial?

This trial is for therapists, their supervisors, and clients at Philadelphia community mental health centers. Participants must be able to conduct therapy in English, agree to use session recordings for research, and have internet access.

Inclusion Criteria

I can participate in therapy sessions in English.

Therapists: Employed at a Philadelphia CMH treatment center that allows the recruitment and participation of therapists in research-related activities

I can participate in therapy sessions in English.

Exclusion Criteria

I am not willing to let researchers access my therapy session recordings.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pilot Field Trial

A single-arm pilot field trial to identify and address barriers to implementing LyssnCBT in a community mental health context

2 weeks

4 sessions per therapist

Main Trial

A randomized stepped-wedge study comparing LyssnCBT to services as usual across multiple community mental health clinics

18 months

Weekly therapy sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LyssnCBT

Trial Overview The study tests LyssnCBT, a digital tool designed to improve the quality of Cognitive Behavioral Therapy (CBT). It will compare the effectiveness of CBT with LyssnCBT support against usual care without this technology.

How Is the Trial Designed?

Group I: LyssnCBT Active Control 1 Intervention

Therapists will use the LyssnCBT tool with clients for recording and session-sharing functionalities. Therapists and supervisors will also have access to LyssnCBT features like speech-to-text transcription, annotation tools, and AI-generated metrics.

Group II: SAU (services-as-usual) Active Control 1 Intervention

Therapists will use the LyssnCBT tool with clients for recording and session-sharing functionalities. No other LyssnCBT features will be available for therapist or supervisor review.

LyssnCBT is already approved in United States for the following indications:

Approved in United States as LyssnCBT for:

• Cognitive Behavioral Therapy (CBT) for mental health disorders and addiction

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Lyssn.io, Inc.

Industry Sponsor

Trials

4

Recruited

2,500+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

In a study involving 1,205 users of the Wysa app for mental health, users reported a strong therapeutic alliance with the AI conversational agent, with scores comparable to traditional therapy methods like CBT.

Over a brief period of 3 days, users' perceptions of their bond with Wysa improved, indicating that digital mental health services can effectively foster a therapeutic relationship similar to that found in face-to-face therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Therapeutic Alliance With a Free-Text CBT Conversational Agent (Wysa): A Mixed-Methods Study. Beatty, C., Malik, T., Meheli, S., et al.[2022]

The study involving 594 patients showed that implementing computerized outcome feedback (OF) technology in therapy for depression and anxiety did not significantly change clinical outcomes, as measured by PHQ-9 and GAD-7 scores, compared to traditional methods.

However, the use of OF led to a significant reduction in the average duration and cost of treatment, suggesting that OF can enhance the efficiency of stepped care psychological services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving the efficiency of psychological treatment using outcome feedback technology. Delgadillo, J., Overend, K., Lucock, M., et al.[2018]

Project AFFECT aims to create an AI-based software, LyssnCBT, to automatically assess the quality of cognitive behavioral therapy (CBT) sessions, which could enhance training and supervision for therapists and improve treatment outcomes for clients.

In a planned Phase II trial involving 1,875 clients, the effectiveness of LyssnCBT will be evaluated to see if it can improve therapist skills, client outcomes, and reduce client drop-out rates, marking a significant step towards scalable quality assurance in psychotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing the quality of cognitive behavioral therapy in community mental health through artificial intelligence generated fidelity feedback (Project AFFECT): a study protocol. Creed, TA., Salama, L., Slevin, R., et al.[2023]

An automated feedback system using machine learning and speech processing technologies was developed to provide therapists with real-time quality metrics on their motivational interviewing skills, making the feedback process more efficient and scalable.

In a study with 21 therapists, the majority found the system easy to use and reported that the feedback aligned with their self-assessment, indicating strong potential for integrating this technology into regular psychotherapy training and practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design feasibility of an automated, machine-learning based feedback system for motivational interviewing. Imel, ZE., Pace, BT., Soma, CS., et al.[2022]

The moderated online social therapy (MOST) web application is being developed as a cost-effective and engaging alternative for youth mental health interventions, particularly for those recovering from early psychosis, as part of a 5-year randomized controlled trial.

MOST aims to enhance user engagement and therapy content delivery through advanced computational and artificial intelligence methods, including natural language analysis and chatbot technologies, demonstrating its potential viability in clinical research settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Artificial Intelligence-Assisted Online Social Therapy for Youth Mental Health. D'Alfonso, S., Santesteban-Echarri, O., Rice, S., et al.[2020]

This study will evaluate the effectiveness of an innovative internet-based cognitive behavioral therapy (iCBT) program enhanced by artificial intelligence (AI) technologies to improve depression among 1400 healthy workers during the COVID-19 pandemic.

The program, called SMART-CBT, consists of a 6-week course with machine-guided exercises and aims to provide a cost-effective mental health solution that can be widely disseminated, marking the first randomized controlled trial of its kind.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of an Internet-Based Machine-Guided Stress Management Program Based on Cognitive Behavioral Therapy for Improving Depression Among Workers: Protocol for a Randomized Controlled Trial. Kawakami, N., Imamura, K., Watanabe, K., et al.[2021]

A systematic review of 10 studies found that using artificial intelligence (AI), particularly conversational AI agents like chatbots, can significantly enhance psychotherapy outcomes and reduce symptoms in patients with emotional disorders.

Patients reported high satisfaction and engagement when AI was integrated into therapy, suggesting that AI can make psychological interventions more personalized and effective, although further robust research is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Artificial Intelligence to Enhance Ongoing Psychological Interventions for Emotional Problems in Real- or Close to Real-Time: A Systematic Review. Gual-Montolio, P., Jaén, I., Martínez-Borba, V., et al.[2022]

Citations

1. lyssn.io lyssn.io/

Lyssn Lyssn invented the only artificial intelligence training and QI platform that uses gold-standard evaluation tools to assess and improve fidelity to evidence- ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36127689/

Enhancing the quality of cognitive behavioral therapy in ... Project AFFECT will develop and evaluate an AI-based software system to automatically estimate CBT fidelity from a recording of a CBT session.

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05340738/ai-based-fidelity-feedback-to-enhance-cbt

AI-Based Fidelity Feedback to Enhance CBT This study will implement a technology to assess and enhance the quality of EBPs like Cognitive Behavioral Therapy (CBT)

4. withpower.com withpower.com/trial/phase-cognitive-behavioral-therapy-6-2022-c1829

AI-Based CBT Enhancement for Mental Health This trial tests a digital tool called LyssnCBT, which helps therapists improve their therapy sessions by providing feedback. The study targets therapists ...

5. lyssn.io lyssn.io/first-ai-study-of-its-kind-now-underway/

First AI study of its kind now underway The scalable fidelity tool will estimate the effectiveness of CBT in recorded therapeutic sessions and support behavioral health providers in ...

6. trialx.com trialx.com/clinical-trials/listings/259300/ai-based-fidelity-feedback-to-enhance-cbt/

AI-Based Fidelity Feedback to Enhance CBT This study will implement LyssnCBT in 5 community mental health agencies, beginning with a single-arm pilot field trial to identify and address ...