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

NCT04486742 | Completed

• 1 other identifier: IRB 2019-2560
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atopic Dermatitis

Keywords

Pediatric

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Itch Rumination Questionnaire

  Baseline to Week 4

• PROMIS Anxiety and Depression

  Baseline to Week 4

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

  Baseline to Week 4

Study Arms (2)

Itch CBT Arm

EXPERIMENTAL

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

Usual Care Arm

NO INTERVENTION

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.

Interventions

Itch CBT BEHAVIORAL

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

Itch CBT Arm

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Inability to comprehend and complete questionnaires.
• History of intellectual disability or psychosis.

Sponsors & Collaborators

• Northwestern University: lead
• Ann & Robert H Lurie Children's Hospital of Chicago: collaborator

Study Sites (1)

Lurie Children's Hospital

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Amy Paller, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 27, 2020
• Study Start: September 1, 2020
• Primary Completion: December 21, 2021
• Study Completion: December 21, 2021
• Last Updated: November 9, 2023

Record last verified: 2023-11

Locations

US (1)