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Trial record 2 of 5 for:    cognitive behavioral therapy | Atopic Dermatitis

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04486742
Recruitment Status : Active, not recruiting
First Posted : July 27, 2020
Last Update Posted : February 17, 2022
Sponsor:
Collaborator:
Ann & Robert H Lurie Children's Hospital of Chicago
Information provided by (Responsible Party):
Amy Paller, Northwestern University

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Itching

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.



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)



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04486742


Locations
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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
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Principal Investigator: Amy Paller, MD Northwestern University
  Study Documents (Full-Text)

Documents provided by Amy Paller, Northwestern University:
Informed Consent Form  [PDF] June 19, 2020

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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    Key Record Dates
Last Update Posted: February 17, 2022
Last Verified: February 2022

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