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OpenTrials
Completed

NCT Number: NCT04486742

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

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

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Key information

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lurie Children's Hospital

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Itch CBT

Behavioral

Telemedicine CBT sessions with a therapist to address atopic dermatitis related concerns.

Primary outcomes

  1. Itch Severity Numerical Rating Scale

    Time frame: Baseline to Week 4

    Numerical rating scale to assess itch severity, scale of 0-10, higher score means higher itch severity and worse outcome.

Secondary outcomes

  1. Itch Rumination Questionnaire

    Time frame: Baseline to Week 4

    Questionnaire to assess common fear and anxiety around itch

  2. PROMIS Anxiety and Depression

    Time frame: Baseline to Week 4

    Questionnaire to assess anxiety and depression symptoms in pediatric populations

  3. PROMIS Pediatric Itch - Short Form 1 (2+6)

    Time frame: Baseline to Week 4

    Questionnaire to assess level and severity of itch and common disturbances due to itch (social, emotional, physical)

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Ann & Robert H Lurie Children's Hospital of Chicago

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 27, 2020
Registry last updated
Nov 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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