An Exploratory Study to Evaluate a Digital Intervention to Disrupt Scratching in Atopic Dermatitis and Psoriasis

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

Inclusion criteria

• Fluent in written and spoken English, confirmed by ability to read, understand and sign the informed consent form (ICF).
• Lives in the United States.
• Aged 18 years or older.
• Itch NRS ≥ 4 during screening.
• Meets indication-specific inclusion criteria (see Appendix 1), as reported by the study participant with adequate clinical documentation. (Documentation to be provided to the study team upon request.)
• Has an active email address and is willing and able to receive and respond to email messages.
• Has access to an internet connection during the study duration.
• Willing and able to comply with the study protocol and assessments.
• Is the sole user of an iPhone with an iPhone operating system (OS) 14 or later or a smartphone with an Android OS 10 or later for the duration of the study.
• Is willing and able to receive Short Message Service (SMS) text messages and notifications on their smartphone.

Exclusion criteria

• Pregnant or planning to become pregnant.
• Visual, dexterity or cognitive deficit so severe that it precludes the use of an App-based, reaction-time-based activity per investigator judgment.
• Severe psychiatric disorder involving a history of psychosis (e.g., schizophrenia, bipolar disorder or severe personality disorders).
• Psychiatric hospitalization in the past 6 months.
• Participation in any research study (including studies on psychotherapy, mindfulness, cognitive training or pharmacological treatment) during the past 3 months.
• Initiation or change in primary-disease-specific medication within 30 days prior to entering the study.
• Self-reported substance-use disorder within the past 1 year.
• Currently experiencing a skin infection.
• Planning the introduction of new therapies (including studies on psychotherapy, mindfulness, cognitive training or pharmacological treatment) during the 7-week study period.
• Anticipating a change in current pharmacological or psychotherapy treatment regimen during the 7-week study period.