Atopic DermatitisNCT04486742
Brief Cognitive Behavioral Therapy to Treat Itch Rumination "Itch CBT" in Eczema
A study testing Itch CBT in people with Atopic Dermatitis, run by Northwestern University at 1 site in United States.
Trial summary
The main purpose of this study is to adapt cognitive behavior therapy (CBT) to improve itch in children with eczema. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Itch CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 21 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Inability to comprehend and complete questionnaires.
- History of intellectual disability or psychosis.
Trial locations and contacts
1 site in 1 country.
About this study
The main purpose of this study is to adapt cognitive behavior therapy (CBT) to improve itch in children with eczema.
Read the 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
- Being tested
- Itch CBT
- Keywords
- Pediatric
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Itch CBTBehavioural
Telemedicine CBT sessions with a therapist to address atopic dermatitis related concerns.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 4
Secondary outcomes (3)
Itch Rumination Questionnaire
Questionnaire to assess common fear and anxiety around itch
Measured: Baseline to Week 4
PROMIS Anxiety and Depression
Questionnaire to assess anxiety and depression symptoms in pediatric populations
Measured: Baseline to Week 4
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)
Measured: Baseline to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start1 Sep 2020
- Primary completion21 Dec 2021
- Study completion21 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Ann & Robert H Lurie Children's Hospital of Chicago
- Responsible party
- Principal investigator, Amy Paller, Northwestern University
- Investigators
- Amy Paller, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04486742
- Sponsor's protocol ID
- IRB 2019-2560
- Status last verified
- Nov 2023
- First submitted
- 14 Jul 2020
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Cognitive Behavioral Therapy to Treat Itch Rumination "Itch CBT" in Eczema
- ClinicalTrials.gov ID
- NCT04486742
- Acronym / sponsor ID
- IRB 2019-2560
- Conditions
- Atopic Dermatitis
- Keywords
- Pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Ann & Robert H Lurie Children's Hospital of Chicago
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 21 Dec 2021 (actual)
- Study completion
- 21 Dec 2021 (actual)
- First posted
- 27 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Itch CBT Arm | Experimental | Behavioral: Itch CBTParticipants 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. |
| 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. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Inability to comprehend and complete questionnaires.
- History of intellectual disability or psychosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Itch CBTTelemedicine CBT sessions with a therapist to address atopic dermatitis related concerns. | Behavioural | Itch CBT Arm |
Primary outcome
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.
3 secondary outcomes
Itch Rumination Questionnaire
Time frame: Baseline to Week 4
PROMIS Anxiety and Depression
Time frame: Baseline to Week 4
PROMIS Pediatric Itch - Short Form 1 (2+6)
Time frame: Baseline to Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Paller, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Itch CBT in people with Atopic Dermatitis, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Itch Severity Numerical Rating Scale (time frame: Baseline to Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.