Brief Cognitive Behavioral Therapy to Treat Itch Rumination "Itch CBT" in Eczema
Phase: NA
Conditions: Atopic Dermatitis
Sponsor: Northwestern University

Brief Cognitive Behavioral Therapy to Treat Itch Rumination “Itch CBT” in Eczema 
 
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PROTOCOL TITLE: Brief Cognitive Behavioral Therapy to Treat Itch Rumination 
“Itch CBT” in Eczema 
 
Funded by the National Eczema Association  
 
 
 
PRINCIPAL INVESTIGATOR: 
Amy Paller, MD 
 
 
 
Professor 
 
 
 
Northwestern University and Lurie Children’s Hospital 
 
 
 
Department of Dermatology 
 
 
 
Feinberg School of Medicine 
676 N Saint Clair Street, Suite 1600 
Chicago, IL 60611 
 
Anna Fishbein, MD 
 
 
 
Assistant Professor of Pediatrics 
 
 
 
Ann & Robert H. Lurie Children’s Hospital of Chicago 
 
 
 
Department of Pediatrics 
 
 
 
Feinberg School of Medicine 
 
 
 
255 E Chicago Ave, Box #60 
 
 
 
Chicago, IL 60611 
 
 
 
 
James Griffith, PhD 
 
 
 
Associate Professor 
 
 
 
Northwestern University 
 
 
 
Department of Medical Social Sciences 
 
 
 
Feinberg School of Medicine 
 
 
 
625 N Michigan Ave, Floor 27 
 
 
 
Chicago, IL 60611 
                                     
 
 
VERSION NUMBER: Version 3 
 
VERSION DATE:  6/24/2020 
 
 
 

Brief Cognitive Behavioral Therapy to Treat Itch Rumination “Itch CBT” in Eczema 
 
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Table of Contents 
1.0 
Objectives ................................................................................................................ 3 
2.0 
Background .............................................................................................................. 3 
3.0 
Hypothesis and Specific Aims ................................................................................. 4 
4.0 
Inclusion and Exclusion Criteria .............................................................................. 4 
5.0 
Procedures Involved ................................................................................................. 5 
6.0 
Data Management .................................................................................................. 10 
7.0 
Risks and Benefits to Subjects ............................................................................... 11 
8.0 
Ethical Considerations ........................................................................................... 12 
9.0 
References .............................................................................................................. 13 
 
 
LIST OF ABBREVIATIONS 
AD 
Atopic Dermatitis 
CBT 
Cognitive-behavioral therapy  
PROMIS  Patient-Reported Outcomes Measurement Information Systems 
IRB 
 Institutional Review Board 
      PRO 
Patient Reported Outcomes 
      QOL 
Quality of life 
      PSC-C 
Pain Castastrophization Scale for Children adapted for itch  
      PIQ-C  
PROMIS Itch Questionnaire-Children 
      CDLQI 
Children’s Dermatology Life Quality Index 
      NRS 
Numeric Rating Scale 
      POEM 
Patient Orientated Eczema Measure 
       
       
    
 
 

Brief Cognitive Behavioral Therapy to Treat Itch Rumination “Itch CBT” in Eczema 
 
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1.0 
Objectives 
 
Chronic itch is one of the most difficult to treat symptoms in atopic dermatitis 
(AD; eczema). Many children with eczema suffer from a chronic focus (rumination) on 
itch. Cognitive Behavioral Therapy (CBT) intervention is effective in treating rumination 
on pain in other chronic diseases, and would likely be successful to treat itch in eczema. 
In this project we will develop an “Itch CBT” intervention specific for itch rumination in 
eczema. After developing a standard protocol based on input from patients, parents, 
clinicians and the National Eczema Association, we will then pilot the intervention in our 
multidisciplinary eczema clinic. The total intervention will last approximately one month. 
The intervention will consist of four 60-minute telehealth sessions with children and their 
parent/guardian. The first visit will be done ~60  directly after a telehealth clinic visit to 
assess areas of difficulty followed by 3 weekly telehealth visits  to assess progress and 
implementation, provide further instruction, and review as necessary. At each time-point, 
we will assess how much the intervention decreased itch, improved medication 
adherence, and improved other quality of life concerns (anxiety, depression, sleep, and 
stigma). Future directions will include making the Itch CBT protocol widely available 
and securing an NIH grant to broadly test the efficacy. 
 
2.0 
Background 
 
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, its possible causes 
and correlates. 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-behavioral 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. Through behavioral strategies, such as mindfulness and meditation 
activities, exposure, or distraction, the individual can learn to function in spite of their 
physical symptoms and cope more effectively.  
 
We propose to create a protocol for Itch CBT that focuses on itch rumination and 
anxiety in eczema for children ages 8-17 years. We hypothesize that an Itch CBT 
intervention is an effective, non-medication based, easy to implement strategy to improve 
itch in children with eczema. Our first aim was to develop an Itch CBT protocol specific 
for children with eczema. With the input of children with eczema and their families as to 
the nature of their symptom-related distress, we created a brief intervention and 
questionnaire to measure itch-related distress and rumination and a set of cognitive, 

Brief Cognitive Behavioral Therapy to Treat Itch Rumination “Itch CBT” in Eczema 
 
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behavioral, and relaxation strategies to combat itch rumination. With expert input from 
the National Eczema Association and our research team, we have formalized a protocol 
for Itch CBT. In our second aim, we will pilot the protocol in a brief (4 session) 
intervention as part of an interdisciplinary AD clinic, comparing Itch CBT to usual care 
(our standard educational handouts).  
 
Because each group will have similar levels of eczema severity and will be 
receiving the same level of medical care, we will be able to attribute changes over time 
between the two groups to this mental health intervention. We predict that patients treated 
with Itch CBT will show significantly less itch and less severe itch, as well as 
significantly greater quality of life, at follow-up compared to those receiving standard 
treatment. Predicted secondary outcomes include decreased rumination on itch, sleep 
disturbance, depression, and anxiety, as well as improved medication adherence, and 
social/family functioning. This pilot study will allow us to measure itch rumination, its 
effects on children with AD, and the efficacy of Itch CBT in itch rumination. With this 
preliminary data, we can apply for NIH funding to provide more extensive evidence for 
the efficacy of Itch CBT in treating itch rumination; ideally we hope to develop an Itch 
CBT protocol that can easily be implemented by trained personnel in the clinic setting or 
even as an online tool for patients. The National Eczema Association is the perfect 
partner for our research team to help develop and disseminate this intervention. 
 
 
3.0 
Hypothesis and Specific Aims 
 
Hypothesis: Our overall hypothesis is that a brief CBT intervention to treat itch 
rumination is an effective adjunctive strategy to improve itch in AD.  
 
Aim 1: Develop and refine a brief, user-friendly, easily deployable CBT intervention to 
treat itch rumination (Itch CBT) for pediatric AD. We will conduct semi-structured 
interviews of 20 patient/parent dyads to tailor a CBT rumination intervention for itch in 
AD to determine the best cognitive and behavioral strategies to implement in Itch CBT. 
Both open- and close-ended questioning will be used to allow for patient suggestions for 
new material, as well as input on proposed materials and strategies. 
 
Aim 2: Determine the efficacy of the itch rumination intervention in reducing distress 
related to AD and itch, as well as correlates of AD that affect quality of life, such as 
social concerns and sleep disturbance. Preliminary data will also be collected to 
determine the validity of a child and parent-proxy questionnaire designed to measure 
rumination on itch in AD.    
 
 
4.0 
Inclusion and Exclusion Criteria  
 
4.1 Inclusion Criteria: 
1. Moderate to severe atopic dermatitis [assessed by Patient Oriented Eczema Measure 
(POEM) score of >-8 OR NRS itch score of >= 4]. 

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2. English speaking (restriction of PROMIS measure). 
3. Age 8-17 years. 
4. Currently receiving treatment at Lurie Children’s Hospital for atopic dermatitis. 
5. Parent or guardian available to participate in protocol. 
6. For Aim 2, Have sufficient technology (e.g., cell phone, computer, tablet, etc.) that can 
be used to access Zoom conference technology for telemedicine visits. 
4.2 Exclusion Criteria: 
1. Inability to comprehend and complete questionnaires. 
2. History of intellectual disability or psychosis. 
3. For Aim 2, enrollment in Aim 1.  
5.0 
Procedures Involved 
5.1 Overall Study Design 
The overall study design is to develop a brief CBT intervention tailored to itch 
rumination via qualitative methods, including creating an interview guide with closed-
and open-ended questions for stakeholders concerning itch-related distress and 
rumination. From these interviews, the itch rumination CBT will be created to address 
common fears and anxiety around itch,  ruminative thoughts concerning itch, and other 
correlates associated with lowered quality of life in AD. This intervention will then be 
tested in a pilot RCT to compare the brief CBT intervention to usual care. Although 
therapists will not be blinded to intervention group, the research assistant assessing and 
analyzing outcomes with patients and their caregiver will be blinded to which 
intervention they received. Figure 1 summarizes our interventional model of CBT Itch.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Target Population: A convenience sample of children (8-17 years) with moderate-severe 
AD (and one parent) will be recruited from our group’s multidisciplinary AD clinic.  
Figure 1. Model of Improving Itch in atopic dermatitis 
using the “CBT Itch” Intervention 
 
Figure Caption. Chronic itch leads to anxiety, rumination, and 
worry about symptoms, in turn leading to sleep disturbance and 
a continued focus on itch sensations. By reducing rumination, 
anxiety, and worry, CBT can perturb these maladaptive processes 
leading to less itch, less attention to itch, and better sleep. Dotted 
lines indicate the hypothesized relationships improved by CBT.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Atopic 
dermatitis 
Chronic itch 
 Rumination 
 Anxiety 
 Perseverative worrying 
Worsening itch 
Scratch 
Sleep disturbance 
Increased 
attention to itch 
 
CBT 

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Patients are referred into this clinic through several “recruitment sites.” The diverse racial 
and ethnic demographics are summarized in Table I. The age group is chosen because all 
measures are validated in this age group, and cognitive interventions are easiest to 
implement in this narrow age group for a pilot study. Future work would expand to 
younger age groups. 
 
 
 
 
 
 
 
 
 
 
A strength of this application is the volume and diversity of patients seeking treatment at 
the interdisciplinary pediatric allergy/dermatology clinic Lurie Children’s Hospital, 
allowing for a wide range of racial, ethnic, and socioeconomic diversity. 
 
Participants in the active and control conditions will be matched for age, gender, and 
disease severity. All participants will be compensated $25 for each visit for their time and 
to cover the cost of transportation. Inclusion and exclusion criteria are listed above in the 
previous section. 
 
5.2 Aim 1 Study Design 
Step 1: Conduct Qualitative Interviews to Develop Itch CBT 
The CBT for itch rumination protocol and measure will be derived from 
qualitative (semi-structured) interviews with patients and families with AD from the 
interdisciplinary clinic at Ann & Robert H. Lurie Children’s Hospital, as well as via 
expert input from the study team. Qualitative interviews will be one-on-one with the 
patient and caregiver separately and will begin with open-ended questions to avoid 
biasing the participants with our own preconceptions of their needs. Example questions 
will include “When are you [your child] thinking about the itch most?” and “What would 
help take your mind off the itch?”. After open-ended questions, we will present 
participants with our conceptualization of itch rumination to ensure it accurately reflects 
their experiences, as well as questions adapted from the PCS-C for itch to determine 
whether these questions accurately reflect their experiences of itch rumination. 
Participants will also be presented with various options and directed questions about their 
preferences for strategies to cope with itch rumination. Options for discussion will 
include behavioral strategies, such as pleasant activities to distract from the itch; 
cognitive interventions, such as self-questioning to de-escalate catastrophizing the itch 
(e.g. “The itching will never stop” and fears of the itch returning); and relaxation 
strategies, such as progressive muscle relaxation and diaphragmatic breathing when 
distraction is not possible, such as during the night. These strategies are the primary 
Table I. Racial and Ethnic Demographics of Recruitment Sites                              
 Recruitment Sites 
African-
American 
Hispanic 
Caucasian 
Asian 
Other 
Clark-Deming Outpatient 
36% 
46% 
15% 
3% 
<1% 
Uptown Clinic 
38% 
35% 
13% 
9% 
5% 
La Rabida Hospital 
74% 
11% 
8% 
unknown 
6% 
Northbrook Lurie 
Outpatient 
2% 
7% 
80% 
6% 
5% 
Lurie Children's Outpatient 
9% 
23% 
47% 
4% 
17% 
 

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interventions of CBT and have been found particularly beneficial in treating physical 
difficulties, such as chronic pain 25.  
 
For Aim 1, 20 patient-parent dyads (40 participants) of children with moderate/severe 
AD will be recruited for qualitative interviewing with a research assistant to provide 
feedback on the concept of itch rumination and therapeutic techniques to be included in 
CBT for itch rumination. Sample size for the interviews is based on our study team’s 
experience conducting qualitative research in support of protocol development and 
clinical health research. To ensure that qualitative findings are representative, research 
must 1) include key characteristics of the population thought to influence the outcomes of 
interest in the study sample; 2) confirm that the concepts are adequately described by 
study participants; and 3) bring participants into the study until no new themes, or 
relevant concepts, are obtained.  This point of redundancy is known as theoretical 
saturation 54,55. It has been suggested that 20 patient-parent dyads is generally adequate to 
reach saturation 56-58. 
Step 2: Develop and refine the Itch CBT protocol. 
 
Qualitative data from Step 1 will be analyzed systematically using a constant 
comparative approach 59. Trained coders will independently generate a preliminary list of 
emergent themes 60.  Next, the coders will meet to discuss initial thoughts, insights, and 
observations for the development of initial coding categories. Through a systematic 
analysis process, analysts will continually refine themes by collapsing redundant and 
removing irrelevant themes and suggested treatments. Once no new categories have 
emerged, coding dictionaries will be developed for the remaining analysis 61. We will 
construct a saturation grid to track themes as they emerge and determine when no new 
relevant information is obtained.  Coded data will be summarized and the most important 
themes in terms of prevalence and/or impact will be identified. These themes, data 
representing the themes in the words of patients and families, will form the basis for the 
Itch CBT intervention. 
  
The study team and key stakeholder (National Eczema Association) will then 
meet and agree to the best protocol to target and address themes related to itch rumination 
generated during qualitative interviews. The result of Aim 1 will be a standardized 
protocol that can be tested in Aim 2. 
5.3 Aim 2 Study Design 
Step 3 Implement CBT Itch compared to usual care in a RCT.  
 
Based upon the interviews conducted in Aim 1, patients with atopic dermatitis 
reported significant concerns in addition to preoccupation with itch and scratching, 
specifically regarding social difficulties, anxiety, sleep challenges, and difficulty with 
concentration. Thus, the treatment was expanded to address these multiple areas of 
concern. Additionally, parents of patients reported significant concerns about scheduling 
office appointments because of absences from work and school due to multiple 
appointments for medical providers. For this reason, it was decided that the primary 
method of intervention would be provided via telemedicine.   
 

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We plan to recruit 24 patient-parent dyads (48 total participants) stratified by 
child’s age (n =6: 8-12, n = 6: 12-17 years) to the CBT itch rumination intervention. 
Usual care will be provided to 12 AD patients, matched on gender and itch severity. Itch 
severity will be based on the NRS Itch Severity score. Potential participants will be 
recruited from Lurie Children’s Dermatology and Allergy Departments. If patients have 
an upcoming clinic (or remote clinic visit) scheduled, they will be contacted prior to their 
clinic visit by a study coordinator/provider and will be provided with a brief description 
of the study to determine interest in order to allow patients to schedule sufficient time for 
study activities following their clinic appointment. If patients do not have an upcoming 
clinic visit, they will be contacted by phone by a study coordinator/provider and given a 
brief description of the study. If interested, participants will be screened using the 
inclusion/exclusion criteria (see Screening Questionnaire). If eligible, patients will be e-
consented to the study using REDCap e-consent procedures by a study coordinator. A 
study coordinator will email a link to the e-consent form to the participant and then 
thoroughly explain the study, allowing time for participants to ask questions. If 
participant is still interested, they will be instructed to sign the e-consent form using the 
link. After participants have been e-consented, they will be randomized to one of the 
study conditions (usual care vs. CBT). Following e-consent, participants will be emailed 
a copy of their signed e-consent form. Following their clinic appointment, all participants 
will complete study questionnaires (see Table of Assessments below).  
 
Randomization Procedures: Participants will be randomized to one of two groups: 
(1) Itch CBT or (2) Usual care. Randomization will occur on a 1:1 ratio and within strata, 
which are gender (male vs. female) and Itch Numerical Rating Scale (4-6 vs. 7-10). 
Participants will be randomized to treatment based on a predetermined list within each 
strata created using the blockrand package of R. Randomization will occur by blocks, 
with varying block sizes, in accord with recommended methods for RCTs. The 
randomization key will be linked to a unique study ID number, as well as to a treatment 
condition (Itch CBT vs. Usual Care). Participants will be aware that there are different 
arms they can be assigned to and will know which randomization group they are 
assigned. 
 
 
For participants randomized to the Usual Care Arm: 
Participants randomized to the Usual Care arm of the study will receive eczema 
educational materials that are typically provided by their health care provider after a 
clinic (or telehealth) visit. Examples include an eczema action plan that is created by the 
provider with the patient and includes daily skincare as well as special skincare 
instructions for eczema flares, handouts on recommendations for dry skin, etc. 
Participants in the Usual Care arm will complete the same schedule of study surveys (see 
Table of Assessments below) as participants randomized to the CBT arm.  
 
For participant randomized to the CBT Arm: 
Participants randomized to the CBT arm of the study will be contacted by their study 
therapist to complete an initial telehealth assessment (see Assessment Interview 
document) about understanding of AD, adherence to medication, strategies they use to 

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cope with itch, social concerns, mood and anxiety concerns related to AD, sleep 
concerns, and areas of functional impairment due to AD.  
 
Following their assessment, families will be instructed on how to download a free version 
of the Zoom application onto their internet-capable personal device, with specific details 
on how to connect for follow-up telehealth visits. Resources will be provided to families 
for technical support. Therapists will then follow up with participants for three sessions 
on a weekly basis via telehealth on Northwestern Zoom, which is encrypted to increase 
security and privacy. Sessions will include instruction on mindfulness-based activities, 
behavioral interventions to improve adherence, action planning during flares, and coping 
mechanisms to help cope with social challenges (see CBT Supplemental Materials). 
Participants will review the session with their parents, in conjunction with their therapist, 
and be given homework to complete for the following week. Following each therapy 
session, participants will complete study surveys via REDcap and at 4 weeks following 
the intervention. Participants will have up to 2 weeks to complete the follow-up 
questionnaires. 
Table of Assessments for Children: 
Assessments: 
Visit 1 
Visit 2 
Visit 3 
Visit 4 
Follow-Up 
Itch Rumination Questionnaire - Child 
X 
 
 
 
X 
X 
Stigma Short-Form 
X 
 
 
X 
X 
PROMIS Pediatric Profile – Anxiety & 
Depression 
 
X 
 
 
 
 
 
 
X 
 
X 
PROMIS Sleep – Child 
X 
 
 
X 
X 
PROMIS Pediatric Itch 
X 
 
 
X 
X 
VAS Dose 
X 
X 
X 
X 
X 
POEM 
X 
 
 
X 
X 
Child’s Derm Life Quality Index 
(CDLQI) 
X 
 
 
X 
X 
Mood NRS 
X 
X 
X 
X 
X 
Itch Severity VAS 
X 
X 
X 
X 
X 
PROMIS Positive Affect 
X 
 
 
X 
X 
PROMIS Meaning and Purpose SF 
X 
 
 
X 
X 
 
Table of Assessments for Parents/Guardians: 
Assessments: 
Visit 1 
Visit 2 
Visit 3 
Visit 4 
Follow-Up 
Itch Rumination 
Questionnaire - Parent 
X 
 
 
 
X 
X 
 

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Parent Proxy Pediatric Itch 
– Short Form 1 (2+6) 
X 
 
X 
 
X 
 
X 
 
X 
 
PROMIS Parent Proxy – 
Anxiety & Depression 
X 
 
 
 
 
X 
X 
 
PROMIS Parent Proxy—
Positive Affect 
X 
 
 
X 
X 
PROMIS Sleep - Parent 
X 
 
 
X 
X 
VAS Dose 
X 
X 
X 
X 
X 
Itch Severity VAS 
X 
X 
X 
X 
X 
Five Facet Mindfulness 
Questionnaire SF 
X 
 
 
X 
X 
PROMIS Family 
Relationships 
X 
 
 
X 
X 
 
5.4 Statistical Analysis Plan – Aim 2 
Because this a clinical trial, our primary statistical approach will be a response profile 
analysis. In this model, the effect of treatment and other variables are used predict the 
outcome over time, but an influence of treatment is not posited for pre-treatment 
assessments. This method is recommended for analyzing clinical trials. We will include 
participants using the intent-to-treat criterion, in which all randomized participants are 
included in the analysis. All aspects of this clinical trial will be reported in accord with 
CONSORT guidelines. Although the response profile analysis will be our primary 
approach, we will also explore alternative approaches. Latent growth curve models use 
all available data (i.e., they do not discard observations with missing data) and provide 
valid inferences in the presence of missing outcome data under the missing at random 
(MAR) assumption. 
 
The primary outcome measures will be the NRS Itch Severity and the CDLQI. All other 
questionnaires will be used as secondary outcome measures.  
Primary outcomes: 
1. NRS Itch Severity 
2. CDLQI 
Secondary outcomes:All other questionnaires listed above. 
 
 
6.0 
Data Management 
 
All of the data will be collected at Lurie Children’s hospital and saved on a secure 
research server that is maintained by Northwestern University. Survey data will be 
maintained within Northwestern University’s secure REDCap system. Only members of 
the authorized study team will have access to these systems.  
 
Protected health information (PHI) necessary for study management (subject name and 
email addresses) is separated from the study data and non-PHI clinical data. This 

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provides additional data security to prevent unauthorized access or release of PHI. 
Subjects will be given a unique subject ID and that will be the link between PHI data and 
non-PHI clinical data. PHI will be marked appropriately in REDCap so data will not be 
exported with identifiers. Any review of data outside of the IRB-approved research team 
will be done only using de-identified data and/or summary tables or figures once the 
appropriate data use agreements are in place.  
 
 
Data Storage for project 
 
The team will create a central database for storage of data on the FSM research server 
within the Department of Medical Social Sciences. Data will be deidentified with a 
separate coded identifier list with subject IDs.  
 
 
7.0 
Risks and Benefits to Subjects 
7.1 Risks: 
Because the study procedures take the form of interviews, there are no safety risks to 
consider in this study. Participation in this study does not involve any physical or 
emotional risk to participants beyond that of everyday life. 
 
Interviews and Questionnaires: Interview participants and/or those completing 
questionnaires can choose to not answer a question, skip a question, request a break, or to 
stop/leave the interview/focus group at any time. Breaks will also be offered to 
participants throughout the interview. There is a very small risk of loss of confidentiality. 
Every measure to safeguard the information will be taken by the research team, including 
keeping all identifying in a locked cabinet and/or password-protected and keeping all 
questionnaire data de-identified using a study ID number. 
 
Audio Recordings: There is a risk of loss of confidentiality with the audio recordings. 
Audio recordings will be destroyed after the study team has reviewed all interview notes 
and confirmed they are complete. In the interim, audio recordings will be kept in a 
secure, locked area to ensure access is only granted to the authorized research personnel. 
 
7.2 Benefits: 
Participants may not have any direct benefit from being in this research study but taking 
part in this research study may enable investigators to create a comprehensive pool of 
items that fully describe the patient experience with AD and itch. It is possible that 
participants randomized to the CBT arm may receive direct benefit in the form of 
decreased symptom/symptom bother from the intervention being tested in this study. 
 
Compensation for Arm 2:  
Participants randomized to the CBT arm will be paid up to a maximum of $130 for their 
participation over the course of the study. Participants randomized to the Usual Care arm 
will be paid up to a maximum of $90 for their participation. Participants will be paid 
according to the following schedule: 

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Payment for 
Assessments (Usual 
Care arm AND 
CBT arm) 
Payment for 
Therapy Visits 
(CBT arm ONLY) 
Visit 1 
$20 
$10 
Visit 2 
$10 
$10 
Visit 3 
$10 
$10 
Visit 4 
$20 
$10 
Follow-up visit 
$20 
$0 
Bonus (for 
completing all 
assessments) 
$10 
$0 
Total per subject 
$90 
$40 
 
Participants will be paid at the end of the study or when they are withdrawn/drop-out. 
Participants will only be paid for the portions of the study that they complete. Payment 
will be in the form of e-gift cards emailed to participants within 2-4 weeks of completing 
their participation in the study. 
 
8.0 
Ethical Considerations 
 
8.1  Human Subjects Protection 
A periodic review must be submitted to the IRB at least once a year. The IRB 
must be notified of completion of the study. After study completion or termination, a 
final report must be provided to close the study. The investigator must maintain an 
accurate and complete record of all submissions made to the IRB, including a list of all 
reports and documents submitted. Adverse events must be submitted promptly to the IRB 
per IRB guidelines. At least once per year, the IRB must review and give written 
approval in order to continue the study. This trial will be conducted in accordance with 
Good Clinical Practices and the Declaration of Helsinki. 
 
8.2 Consent Form 
Prior to study entry, a written parental consent form must be obtained. Assent will be also 
obtained from subjects participating who are 12 years and older. A copy of the consent 
and assent form will be retained in the appropriate study file.  
 
8.3 Protocol Amendments 
All changes must be submitted to the IRB. Protocol modifications that impact subject 
safety or the validity of the study must be approved by the IRB before initiation. 
 
8.4 Retention of Records 
Food and Drug Administration and Good Clinical Practice guidelines require that an 
Investigator retain subject identification codes, subject files, and source data for the 
maximum period of time permitted by the hospital, institution, or private practice, but not 
less than 15 years after the completion or discontinuation of the trial. 

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8.5 Use of Information and Publication 
The Principal Investigator, sub-investigators may publish the results of this study in 
conjunction will appropriate scientific and medical personnel. 
 
9.0 
References 
 
1. 
Shaw TE, Currie GP, Koudelka CW, Simpson EL. Eczema prevalence in the United 
States: data from the 2003 National Survey of Children's Health. J Invest Dermatol. Jan 
2011;131(1):67-73. 
2. 
Koinis-Mitchell D, Craig T, Esteban CA, Klein RB. Sleep and allergic disease: a 
summary of the literature and future directions for research. The Journal of allergy and 
clinical immunology. Dec 2012;130(6):1275-1281. 
3. 
Chamlin SL, Mattson CL, Frieden IJ, et al. The price of pruritus: sleep disturbance and 
cosleeping in atopic dermatitis. Archives of pediatrics & adolescent medicine. Aug 
2005;159(8):745-750. 
4. 
Hon KL, Leung TF, Wong KY, Chow CM, Chuh A, Ng PC. Does age or gender 
influence quality of life in children with atopic dermatitis? Clinical and experimental 
dermatology. Nov 2008;33(6):705-709. 
5. 
Camfferman D, Kennedy JD, Gold M, Martin AJ, Lushington K. Eczema and sleep and 
its relationship to daytime functioning in children. Sleep medicine reviews. Dec 
2010;14(6):359-369. 
6. 
Sack R, Hanifin J. Scratching below the surface of sleep and itch. Sleep medicine 
reviews. Dec 2010;14(6):349-350. 
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