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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04486742
• Other study ID #: IRB 2019-2560
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: December 21, 2021

Study information

• Verified date: November 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 21, 2021
• Est. primary completion date: December 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis

Intervention

Behavioral:
• Itch CBT
Telemedicine CBT sessions with a therapist to address atopic dermatitis related concerns.

Locations

Country	Name	City	State
United States	Lurie Children's Hospital	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Ann & Robert H Lurie Children's Hospital of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Itch Rumination Questionnaire	Questionnaire to assess common fear and anxiety around itch	Baseline to Week 4
Secondary	PROMIS Anxiety and Depression	Questionnaire to assess anxiety and depression symptoms in pediatric populations	Baseline to Week 4
Secondary	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