Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||8 Years - 17 Years|
- - Moderate to severe atopic dermatitis [assessed by Patient Oriented Eczema Measure (POEM)score of >-8 OR NRS itch score of >= 4].
- - English speaking.
- - Currently receiving treatment at Lurie Children's Hospital for atopic dermatitis.
- - Parent or guardian available to participate in protocol.
- - Have sufficient technology (e.g., cell phone, computer, tablet, etc.) that can be used to access Zoom conference technology for telemedicine visits.
- - Inability to comprehend and complete questionnaires.
- - History of intellectual disability or psychosis.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Amy Paller, MD|
|Principal Investigator Affiliation||Northwestern University|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Active, not recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
Eczema is characterized by chronic itch. Many children develop a chronic focus (rumination) on their itch. Rumination is a maladaptive method of responding to distress, in which the individual thinks obsessively about the source of distress. The rumination on chronic itch in eczema can have detrimental effects on one's quality of life, as well as induce significant anxiety about when itch will return, how long it will last, and how it will affect physical and social functioning. Cognitive behavior therapy (CBT) is a frontline treatment for rumination, as it focuses on teaching strategies so that the individual can examine distressing thoughts objectively and determine their validity, replace negative thinking patterns with more adaptive thought patterns, and increase the individual's awareness to their problematic thought patterns. Additionally, CBT helps the individual to implement behavioral strategies to cope with possibly anxiety-inducing situations, such as scratching while trying to go to sleep. The investigators hypothesize that an Itch CBT intervention is an effective, non-medication-based, easy to implement strategy to improve itch in children with eczema.
Experimental: Itch CBT Arm
Participants randomized to the Itch CBT Arm will participate in 4 weekly telehealth sessions with a therapist to address common areas of anxiety related to atopic dermatitis.
No Intervention: Usual Care Arm
Participants randomized to the Usual Care Arm of the study will receive standard of care eczema educational materials that are typically provided by their health care provider after a clinic (or telehealth) visit.
Behavioral: - Itch CBT
Telemedicine CBT sessions with a therapist to address atopic dermatitis related concerns.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Lurie Children's Hospital
Chicago, Illinois, 60611