An Exploratory Study to Evaluate a Digital Intervention to Disrupt Scratching in Atopic Dermatitis and Psoriasis
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full description
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
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
120 participants in 4 patient groups
Trial contacts and locations
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Central trial contact
Research Coordinator
Data sourced from clinicaltrials.gov
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