Clinical trial NCT04486742: Brief Cognitive Behavioral Therapy to Treat Itch Rumination "Itch CBT" in Eczema
Official title: Brief Cognitive Behavioral Therapy to Treat Itch Rumination "Itch CBT" in Eczema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Keywords: Pediatric
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Ann & Robert H Lurie Children's Hospital of Chicago
First posted: 2020-07-27
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Itch Severity Numerical Rating Scale
timeFrame: Baseline to Week 4
Secondary outcomes:
measure: Itch Rumination Questionnaire
timeFrame: Baseline to Week 4
measure: PROMIS Anxiety and Depression
timeFrame: Baseline to Week 4
measure: PROMIS Pediatric Itch - Short Form 1 (2+6)
timeFrame: Baseline to Week 4
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Lurie Children's Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Amy Paller, MD
role: PRINCIPAL_INVESTIGATOR
References: