Cognitive Behavioral Therapy for Eczema

Overseen By Michelle Taddeo, MPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Intellectual disability, Psychosis

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if cognitive behavioral therapy (CBT) can reduce the urge to scratch in children with eczema. Participants in the experimental group will engage in four weekly telehealth sessions focused on managing anxiety related to their skin condition, a method known as Itch CBT. Another group will continue their usual care routine and receive standard eczema education materials. Children with moderate to severe eczema who are already receiving treatment at Lurie Children's Hospital might be suitable for this study. As an unphased trial, this study provides a unique opportunity for children to potentially benefit from a new therapeutic approach while contributing to valuable research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this cognitive behavior therapy is safe for children with eczema?

Research has shown that Cognitive Behavioral Therapy (CBT) can help people with eczema by reducing itching and improving sleep. Although specific safety data for Itch CBT is not available, CBT in general is known to be safe and well-tolerated.

Online CBT has proven effective with minimal therapist involvement. In one study involving 168 adults, self-guided CBT reduced itchiness and improved overall well-being.

The trial is in a phase called "Not Applicable," indicating that the treatment is considered safe enough to test without the usual early safety trials. Overall, CBT is generally regarded as safe with few risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Itch CBT because it offers a fresh approach to managing eczema by addressing the psychological aspect of the condition, specifically itch rumination. Unlike standard treatments that focus on topical creams or systemic medications to reduce inflammation and itch, Itch CBT uses cognitive behavioral therapy through telehealth sessions to help patients manage anxiety related to their eczema. This method aims to break the cycle of persistent itching by changing thought patterns, which could lead to improved quality of life for patients.

What evidence suggests that Itch CBT is effective for improving itch in children with eczema?

Research has shown that Cognitive Behavioral Therapy (CBT) can help reduce itching in people with eczema. In this trial, participants in the Itch CBT Arm will engage in four weekly telehealth sessions with a therapist to address common anxiety areas related to atopic dermatitis. Studies have found that online CBT significantly lowers itch and stress levels in those with atopic dermatitis, a type of eczema. Another study found that treatments like CBT effectively reduce eczema symptoms and the urge to scratch. These findings suggest that CBT could be a promising way to manage itching in children with eczema. ^{1 2 6 7 8}

Who Is on the Research Team?

Amy Paller, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

Inclusion Criteria

English speaking

You have moderate to severe eczema, which is a skin condition that causes itching and rash.

Currently receiving treatment at Lurie Children's Hospital for atopic dermatitis.

Exclusion Criteria

History of intellectual disability or psychosis

Inability to comprehend and complete questionnaires

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants in the Itch CBT Arm will participate in 4 weekly telehealth sessions with a therapist

4 weeks

4 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Itch CBT

How Is the Trial Designed?

Group I: Itch CBT Arm Experimental Treatment 1 Intervention

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.

Group II: Usual Care Arm Active Control 1 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 Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Ann & Robert H Lurie Children's Hospital of Chicago

Collaborator

Trials

275

Recruited

5,182,000+

Published Research Related to This Trial

A systematic review of 19 studies on cognitive behavioral therapy (CBT) for chronic pain found that psychological factors like anxiety, depression, and negative thoughts about pain significantly influence treatment outcomes, with medium to large effect sizes.

Sociodemographic factors had only small effects on CBT outcomes and were not consistently replicable, highlighting the need for more research to identify reliable predictors and improve the consistency of study designs in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of treatment outcome in cognitive behavioural therapy for chronic pain: a systematic review. Forden, G., Ronaghan, S., Williams, P., et al.[2023]

The feasibility trial involving 25 adults with chronic pain and insomnia showed that 64% of participants completed all sessions of the Hybrid CBT, indicating a reasonable level of adherence to this intensive therapy.

Qualitative feedback from participants revealed satisfaction with the Hybrid CBT content, but suggested improvements such as reducing session length and increasing therapist contact, which could enhance adherence in future trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing a hybrid cognitive-behavioural therapy for pain-related insomnia in primary care: lessons learnt from a mixed-methods feasibility study. Tang, NKY., Moore, C., Parsons, H., et al.[2021]

An Internet-based cognitive-behavioral therapy (ICBT) program for obsessive-compulsive disorder (OCD) was found to be effective, significantly reducing OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) in a study of 40 adults over 10 weeks.

Participants reported high satisfaction with ICBT, which was quicker to implement than traditional face-to-face therapy, suggesting that ICBT could be a valuable option to improve access to effective OCD treatment in the United States.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability, Feasibility, and Effectiveness of Internet-Based Cognitive-Behavioral Therapy for Obsessive-Compulsive Disorder in New York. Patel, SR., Wheaton, MG., Andersson, E., et al.[2020]

The Nitra application, an internet-based cognitive behavioral therapy for insomnia (CBT-i), significantly improved sleep efficiency and various sleep parameters in 40 adults with chronic subthreshold to moderate insomnia over a 4-week intervention period.

Participants who adhered closely to the recommended sleep schedule showed a higher likelihood of achieving normal sleep efficiency, highlighting the importance of consistent sleep habits in managing insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of internet-based CBT-I for the treatment of chronic subthreshold to moderate insomnia. Theppornpitak, W., Hemrungrojn, S., Thienwiwatnukul, K., et al.[2023]

The CBT-i Coach mobile app significantly improved subjective sleep outcomes in veterans, with participants reporting reduced insomnia and better sleep quality after a 6-week intervention, despite a decrease in objective sleep time.

The study highlights the importance of using both subjective and objective sleep measures, as the objective data revealed a decrease in sleep time and no changes in REM sleep or sleep efficiency, suggesting potential undiagnosed sleep apnea in participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile App Use for Insomnia Self-Management: Pilot Findings on Sleep Outcomes in Veterans. Reilly, ED., Robinson, SA., Petrakis, BA., et al.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34009282/

Internet-Delivered Cognitive Behavior Therapy for Atopic ... Secondary analyses indicated that internet-delivered CBT also produced significantly larger reductions in itch intensity, perceived stress, ...

2. jamanetwork.com jamanetwork.com/journals/jamadermatology/fullarticle/2779785

Internet-Delivered Cognitive Behavior Therapy for Atopic ... Conclusions and Relevance Internet-delivered CBT appears to be efficacious for reducing symptoms of atopic dermatitis, despite requiring minimal ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04486742

Brief Cognitive Behavioral Therapy to Treat Itch ... The main purpose of this study is to adapt cognitive behavior therapy (CBT) to improve itch in children with eczema. ... Eczema is characterized by chronic itch.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0365059624000291

Are behavioral interventions a better choice for atopic ... This study suggests that behavioral interventions could be effective in treating atopic dermatitis by reducing eczema and scratching severity.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8135053/

Internet-Delivered Cognitive Behavior Therapy for Atopic ... This randomized clinical trial of 102 adult participants with AD found that internet-delivered CBT produced significantly larger reductions of AD symptoms.

6. withpower.com withpower.com/trial/phase-dermatitis-atopic-8-2020-f2c4a

Brief Cognitive Behavioral Therapy to Treat Itch ... Is Itch CBT safe for humans? The research does not provide specific safety data for Itch CBT in humans, but it discusses placebo and nocebo effects on itch ...

7. jamanetwork.com jamanetwork.com/journals/jamadermatology/article-abstract/2827594

Self-Guided vs Clinician-Guided Online Cognitive ... This randomized clinical noninferiority trial investigates whether a brief online self-guided cognitive behavioral therapy intervention is ...

8. news.ki.se news.ki.se/self-guided-online-treatment-helps-with-atopic-eczema

Self-guided online treatment helps with atopic eczema The study, which included 168 adult participants, shows that the treatment's effectiveness in reducing itching, improving sleep and increasing ...