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

• ClinicalTrials.gov Identifier: NCT04486742
• Recruitment Status: Active, not recruiting
• First Posted: July 27, 2020
• Last Update Posted: February 17, 2022
• Sponsor: Northwestern University
• Collaborator: Ann & Robert H Lurie Children's Hospital of Chicago
• Information provided by (Responsible Party): Amy Paller, Northwestern University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Atopic Dermatitis	Behavioral: Itch CBT	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Brief Cognitive Behavioral Therapy to Treat Itch Rumination "Itch CBT" in Eczema
• Actual Study Start Date: September 1, 2020
• Estimated Primary Completion Date: August 31, 2022
• Estimated Study Completion Date: August 31, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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.
2. Children's Dermatology Life Quality Index [ Time Frame: Baseline to Week 4 ]
   Questionnaire to assess impact of eczema on quality of life.

Secondary Outcome Measures :

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)

Eligibility Criteria

• Ages Eligible for Study: 8 Years to 17 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Illinois

Lurie Children's Hospital

Chicago, Illinois, United States, 60611

Sponsors and Collaborators

Northwestern University

Ann & Robert H Lurie Children's Hospital of Chicago

Investigators

• Principal Investigator: Amy Paller, MD; Northwestern University

  Study Documents (Full-Text)

Documents provided by Amy Paller, Northwestern University:

Study Protocol and Statistical Analysis Plan  [PDF] June 24, 2020

Informed Consent Form  [PDF] June 19, 2020

More Information

• Responsible Party: Amy Paller, Study Principal Investigator, Northwestern University
• ClinicalTrials.gov Identifier: NCT04486742
• Other Study ID Numbers: IRB 2019-2560
• First Posted: July 27, 2020
• Last Update Posted: February 17, 2022
• Last Verified: February 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Amy Paller, Northwestern University:

Pediatric

Additional relevant MeSH terms:

Dermatitis, Atopic; Dermatitis; Skin Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases