Brief Cognitive Behavioral Therapy to Treat Itch Rumination Itch CBT in Eczema

Study Overview
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Brief Summary
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The main purpose of this study is to adapt cognitive behavior therapy (CBT) to improve itch in children with eczema.

Detailed Description
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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.

Official Title
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Brief Cognitive Behavioral Therapy to Treat Itch Rumination Itch CBT in Eczema

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Behavioral: Itch CBT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Inability to comprehend and complete questionnaires. History of intellectual disability or psychosis.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Itch CBT Arm<br>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. | Behavioral: Itch CBT<br>* Telemedicine CBT sessions with a therapist to address atopic dermatitis related concerns.<br>|
| No Intervention: Usual Care Arm<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric