What is the mechanism of action of this treatment?

Cognitive Behavioral Therapy (CBT) works by helping patients identify and modify negative thought patterns and behaviors that contribute to their mental health issues. Key mechanisms include cognitive restructuring, which involves challenging and changing unhelpful thoughts, and behavioral activation, which encourages engagement in positive activities to improve mood. These mechanisms are crucial for patients as they provide practical tools to manage and reduce symptoms. Technologies like LyssnCBT enhance these treatments by using speech processing and machine learning to provide objective, performance-based feedback, ensuring high fidelity and quality in therapy sessions. This can lead to more consistent and effective treatment outcomes for patients.

What side effects are associated with this type of intervention?

Cognitive Behavioral Therapy (CBT) is generally well-tolerated with minimal side effects. Common side effects may include temporary increases in anxiety or emotional discomfort as patients confront challenging thoughts and behaviors. Some individuals may experience fatigue or stress due to the effort required to engage in therapy. When CBT is enhanced with technology, such as in the LyssnCBT trial, additional side effects could include frustration or discomfort with using digital tools. However, these side effects are typically mild and transient, making CBT a safe and effective treatment option for many mental health disorders.

What prior FDA approvals exist?

Cognitive Behavioral Therapy (CBT) is a widely used psychotherapy for treating mental health disorders such as depression and anxiety. While CBT itself does not involve FDA-approved drugs, several medications are often used in conjunction with CBT for these conditions. For example, selective serotonin reuptake inhibitors (SSRIs) like fluoxetine and sertraline are FDA-approved for depression and anxiety. The LyssnCBT trial focuses on enhancing the quality and fidelity of CBT through advanced technology, including speech processing and machine learning, to provide objective, performance-based feedback, which represents a significant innovation in the delivery of evidence-based psychotherapies.

What other types of research exist?

Promising alternatives to LyssnCBT for enhancing CBT quality and fidelity include: 1) Woebot, an AI-driven chatbot that provides real-time mental health support and CBT techniques; 2) SilverCloud, a digital mental health platform offering structured CBT programs with therapist support; 3) Mindstrong, which uses digital phenotyping and AI to provide personalized mental health interventions; 4) Talkspace, an online therapy platform that connects users with licensed therapists and offers CBT-based treatment plans; 5) BetterHelp, another online therapy service providing access to licensed therapists with CBT expertise. These tools leverage technology to provide scalable, efficient, and effective mental health care.

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Behavioural Intervention

AI-Based CBT Enhancement for Mental Health (AFFECT Trial)

N/A

Recruiting

Led By David Atkins, PhD

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Clients: Able to participate in therapy sessions conducted in English

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately before weekly therapy sessions for the duration of treatment or through study completion, a maximum of 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a digital tool called LyssnCBT, which helps therapists improve their therapy sessions by providing feedback. The study targets therapists and their clients at community mental health agencies. LyssnCBT uses advanced technology to analyze recorded therapy sessions and offer suggestions for improvement. LyssnCBT is an AI-based software system developed to automatically evaluate therapy sessions, supporting high-quality training and supervision.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

As this trial involves a non-medical intervention focusing on therapy quality assessment through technology rather than medication or medical procedures, traditional side effects are not applicable.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can participate in therapy sessions in English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately before weekly therapy sessions for the duration of treatment or through study completion, a maximum of 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately before weekly therapy sessions for the duration of treatment or through study completion, a maximum of 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately before weekly therapy sessions for the duration of treatment or through study completion, a maximum of 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability of LyssnCBT tools (Acceptability of Intervention Measure; AIM)

Appropriateness of LyssnCBT tools (Intervention Appropriateness Measure; IAM)

Change in client anxiety symptoms (General Anxiety Disorder; GAD-7)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: LyssnCBTActive Control1 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 Control1 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.

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cognitive Behavioral Therapy (CBT) works by helping patients identify and modify negative thought patterns and behaviors that contribute to their mental health issues. Key mechanisms include cognitive restructuring, which involves challenging and changing unhelpful thoughts, and behavioral activation, which encourages engagement in positive activities to improve mood. These mechanisms are crucial for patients as they provide practical tools to manage and reduce symptoms. Technologies like LyssnCBT enhance these treatments by using speech processing and machine learning to provide objective, performance-based feedback, ensuring high fidelity and quality in therapy sessions. This can lead to more consistent and effective treatment outcomes for patients.