← Back to Search

Behavioural Intervention

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

N/A
Recruiting
Led By Torrey A Creed, 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

AFFECT Trial Summary

This trial will assess a new tech-based solution to help therapists deliver evidence-based psychotherapies to people with mental illness and addiction, which could lead to better outcomes and reduce the global mental health burden.

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.Check my eligibility
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.See study design
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.

AFFECT Trial 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.

AFFECT Trial 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
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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

AFFECT 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.

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
1,994 Previous Clinical Trials
42,877,299 Total Patients Enrolled
1 Trials studying Cognitive Behavioral Therapy
2 Patients Enrolled for Cognitive Behavioral Therapy
Lyssn.io, Inc.Industry Sponsor
3 Previous Clinical Trials
600 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,777 Previous Clinical Trials
2,672,415 Total Patients Enrolled

Media Library

LyssnCBT (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05340738 — N/A
Cognitive Behavioral Therapy Research Study Groups: LyssnCBT, SAU (services-as-usual)
Cognitive Behavioral Therapy Clinical Trial 2023: LyssnCBT Highlights & Side Effects. Trial Name: NCT05340738 — N/A
LyssnCBT (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05340738 — N/A
Cognitive Behavioral Therapy Patient Testimony for trial: Trial Name: NCT05340738 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial accept new participants?

"Clinicaltrials.gov reports that this investigation is actively enrolling participants, having been first advertised on the 9th of March and last revised 4 days later."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
What site did they apply to?
The Penn Collaborative for CBT and Implementation Science
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Despite completing CBT I'm still having some daily issues.
PatientReceived 2+ prior treatments
~1054 spots leftby Jun 2025