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| Name | Class |
|---|---|
| Ann & Robert H Lurie Children's Hospital of Chicago | OTHER |
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The main purpose of this study is to adapt cognitive behavior therapy (CBT) to improve itch in children with eczema.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Itch CBT Arm | Experimental | 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. |
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| Usual Care Arm | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Itch CBT | Behavioral | Telemedicine CBT sessions with a therapist to address atopic dermatitis related concerns. |
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| Measure | Description | Time Frame |
|---|---|---|
| Itch Severity Numerical Rating Scale | Numerical rating scale to assess itch severity, scale of 0-10, higher score means higher itch severity and worse outcome. | Baseline to Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Itch Rumination Questionnaire | Questionnaire to assess common fear and anxiety around itch | Baseline to Week 4 |
| PROMIS Anxiety and Depression | Questionnaire to assess anxiety and depression symptoms in pediatric populations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy Paller, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lurie Children's Hospital | Chicago | Illinois | 60611 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 24, 2020 | Jul 10, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 19, 2020 | Jul 10, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| Baseline to Week 4 |
| PROMIS Pediatric Itch - Short Form 1 (2+6) | Questionnaire to assess level and severity of itch and common disturbances due to itch (social, emotional, physical) | Baseline to Week 4 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |