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

NCT ID: NCT04486742

Last Updated: 2023-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2021-12-21

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Itch CBT

Intervention Type: BEHAVIORAL

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Itch CBT

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Amy Paller

Study Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amy Paller, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Lurie Children's Hospital

Chicago, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB 2019-2560

Identifier Type: -

Identifier Source: org_study_id