CT-155 is a novel prescription digital therapeutic (PDT) being developed by Click Therapeutics, Inc. (Click) and Boehringer Ingelheim (BI) using an interactive, software-based intervention to treat schizophrenia
CT-155 is a novel prescription digital therapeutic (PDT) being developed by Click Therapeutics, Inc. (Click) and Boehringer Ingelheim (BI). CT-155 delivers an interactive, software-based intervention for schizophrenia. This is a multi-center, exploratory, single-arm study to evaluate the feasibility and acceptability of medication tracking and educational component of a clinical learning study version of CT-155 in adults diagnosed with schizophrenia. Eligible participants must have a diagnosis of schizophrenia per Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). Participants that meet eligibility criteria will be enrolled in the study on Day 1. The study consists of an up to 7-day screening period, a 49-day engagement period, and an up to 7-day follow-up period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
48
The study app is designed to provide 7-weeks of the medication tracking and educational components in a clinical learning study version of CT-155. This design allows inferences to be made about the usability and acceptability of these components of CT-155. Eligible participants will be enrolled during an in-person clinic visit on Day 1. Participants will then be directed to access the study app and perform tasks each day for the 49-day engagement period.
CT-155 Center
Anaheim, California, United States
CT-155 Center
Torrance, California, United States
CT-155 Center
Hialeah, Florida, United States
CT-155 Center
Lake Mary, Florida, United States
To explore feasibility and acceptability of the medication tracking and educational components of a clinical learning study version of the CT-155 app
Degree of participant engagement with the study app as measured by participant app use data captured in-app
Time frame: Day 49 at the end of treatment period
Change from Week 3 of the Mobile Agnew Relationships Measure
To explore the establishment of a digital working alliance over the course of the Study as assessed by the change from Week 3 to Week 7 of the Mobile Agnew Relationships Measure. The Mobile Agnew Relationships Measures is on a 7-item scale that ranges from "Strongly Disagree" as scale 1 to "Strongly Agree" as scale 7.
Time frame: Change from Week 3 to Week 7 of the Mobile Agnew Relationships Measure
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CT-155 Center
Miami, Florida, United States
CT-155 Center
Irving, Texas, United States
CT-155 Center
Richmond, Texas, United States