CT-100 is a platform that provides interactive, software based therapeutic components that may be used as part of a treatment in future software-based prescription digital therapeutics. One class of CT-100 components are Digital Neuro-activation and Modulation (DiNaMo TM) components. DiNaMo components target key neural systems (including but not limited to systems related to sensory-, perceptual-, affective-, pain-, attention-, cognitive control, social- and self- processing) to optimally improve a participant's health.
CT-100 is a platform that provides interactive, software based therapeutic components that may be used as part of a treatment in future software-based prescription digital therapeutics. One class of CT-100 components are Digital Neuro-activation and Modulation (DiNaMo TM) components. DiNaMo components target key neural systems (including but not limited to systems related to sensory-, perceptual-, affective-, pain-, attention-, cognitive control, social- and self- processing) to optimally improve a participant's health. The purpose of the proposed study is to evaluate initial effects of the DiNaMo component on measures of undesired behavior intensity and related outcomes in a variety of conditions, such as atopic dermatitis and psoriasis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
120
Digital Neuro-activation and Modulation (DiNaMo) component uses implicit training to strengthen inhibitory control. This intervention could help improve cognitive capabilities to help participants overcome the urge to scratch in response to an itch.
The CT-100-D-004-B Processing speed training component uses implicit training targeting processing speed. This intervention could help improve cognitive capabilities to help participants overcome the urge to scratch in response to an itch.
Click Therapeutics
New York, New York, United States
Change in Peak Pruritus Numerical Rating Scale
Change from baseline to Week 4 in the Peak Pruritus Numerical Rating Scale (PP-NRS)
Time frame: Baseline to Week 4
Change in Dermatology Life Quality Index
Change from baseline to Week 4 in the Dermatology Life Quality Index (DLQI)
Time frame: Baseline to Week 4
Change in Quality of Life symptoms
Change in QoL symptoms assessed with the PROMIS®-29+2 Profile v2.1 (PROMIS-29+2 Preference \[PROPr\]) scales (including mood, fatigue, pain interference, sleep, ability to participate in social functioning and cognitive function) from baseline to Week 4
Time frame: Baseline to Week 4
Time in App
Engagement with the App as measured by daily time in the App
Time frame: Baseline to Week 4
Experience with Study App
Experience with the Study App as assessed by the User Experience Questionnaire after the Study App treatment period
Time frame: Week 5
Improved global rating of change
Proportion of participants with an improvement as measured by the Global Rating of Change (GRC) score at Week 4
Time frame: Baseline to Week 4
Frequency of Adverse Events
Frequency of adverse events (AEs)
Time frame: Baseline to Week 5
Severity of Adverse Events
Severity of adverse events (AEs)
Time frame: Baseline to Week 5
Frequency of Serious Adverse Events
Frequency of Serious Adverse Events (AEs)
Time frame: Baseline to Week 5
Severity of Serious Adverse Events
Severity of Serious Adverse Events (AEs)
Time frame: Baseline to Week 5
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