Brief Cognitive Behavioral Therapy to Treat Itch Rumination "Itch CBT" in Eczema
Primary Purpose
Atopic Dermatitis
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Itch CBT
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring Pediatric
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.
Sites / Locations
- Lurie Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Itch CBT Arm
Usual Care Arm
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Children's Dermatology Life Quality Index
Questionnaire to assess impact of eczema on quality of life.
Secondary Outcome Measures
Itch Rumination Questionnaire
Questionnaire to assess common fear and anxiety around itch
PROMIS Anxiety and Depression
Questionnaire to assess anxiety and depression symptoms in pediatric populations
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)
Full Information
NCT ID
NCT04486742
First Posted
July 14, 2020
Last Updated
August 14, 2022
Sponsor
Northwestern University
Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
1. Study Identification
Unique Protocol Identification Number
NCT04486742
Brief Title
Brief Cognitive Behavioral Therapy to Treat Itch Rumination "Itch CBT" in Eczema
Official Title
Brief Cognitive Behavioral Therapy to Treat Itch Rumination "Itch CBT" in Eczema
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Pediatric
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Itch CBT Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care Arm
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Itch CBT
Intervention Description
Telemedicine CBT sessions with a therapist to address atopic dermatitis related concerns.
Primary Outcome Measure Information:
Title
Itch Severity Numerical Rating Scale
Description
Numerical rating scale to assess itch severity, scale of 0-10, higher score means higher itch severity and worse outcome.
Time Frame
Baseline to Week 4
Title
Children's Dermatology Life Quality Index
Description
Questionnaire to assess impact of eczema on quality of life.
Time Frame
Baseline to Week 4
Secondary Outcome Measure Information:
Title
Itch Rumination Questionnaire
Description
Questionnaire to assess common fear and anxiety around itch
Time Frame
Baseline to Week 4
Title
PROMIS Anxiety and Depression
Description
Questionnaire to assess anxiety and depression symptoms in pediatric populations
Time Frame
Baseline to Week 4
Title
PROMIS Pediatric Itch - Short Form 1 (2+6)
Description
Questionnaire to assess level and severity of itch and common disturbances due to itch (social, emotional, physical)
Time Frame
Baseline to Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Paller, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lurie Children's Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Brief Cognitive Behavioral Therapy to Treat Itch Rumination "Itch CBT" in Eczema
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