Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:48 PM
Ignite Modification Date:
2025-12-24 @ 2:48 PM
NCT ID:
NCT06275659
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06275659
Study Brief:
Protocol Section:
NCT06275659