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.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Behavioral: Itch CBT

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Lurie Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 15 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Itch CBT Arm; 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; Telemedicine CBT sessions with a therapist to address atopic dermatitis related concerns.
No Intervention: Usual Care Arm; 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?

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

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: Ann & Robert H Lurie Children's Hospital of Chicago
• Investigators: Principal Investigator: Amy Paller, MD, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): December 21, 2021
• Study Completion (Actual): December 21, 2021

Study Registration Dates

• First Submitted: July 14, 2020
• First Submitted That Met QC Criteria: July 21, 2020
• First Posted (Actual): July 27, 2020

Study Record Updates

• Last Update Posted (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 6, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Pediatric
• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis
• Other Study ID Numbers: IRB 2019-2560

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No