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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a special type of talk therapy to help children with eczema manage their itching. The therapy teaches kids to change how they think about their itch and find better ways to cope with it. This approach aims to improve their quality of life without using medication.

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 data supports the effectiveness of the treatment Itch CBT?

Research shows that cognitive-behavioral therapy (CBT) is effective for chronic pain by addressing negative thought patterns and behaviors. Since chronic itching shares similar psychological mechanisms with chronic pain, such as catastrophizing and avoidance, CBT may also help reduce itching and improve quality of life. ^{1 2 3 4 5}

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, which are generally considered safe as they involve suggestions rather than active treatments. ^{6 7 8 9 10}

How is Itch CBT treatment different from other treatments for this condition?

Itch CBT is unique because it uses cognitive behavioral therapy (CBT), which is a psychological approach that helps change negative thought patterns and behaviors, to specifically address itching. This is different from standard treatments that might focus more on physical symptoms rather than the psychological aspects of itching. ^{2 11 12 13 14}

Research Team

Amy Paller, MD

Principal Investigator

Northwestern University

Eligibility Criteria

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

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

Treatment Details

Interventions

• Itch CBT

Participant Groups

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+

Findings from Research

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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Predictors of treatment outcome in cognitive behavioural therapy for chronic pain: a systematic review. [2023]

2. England pubmed.ncbi.nlm.nih.gov

From the clinic to the lab (and back)-a call for laboratory research to optimize cognitive behavioural treatment of pain. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Cognitive, behavioral, and physiological reactivity to chronic itching: analogies to chronic pain. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Acceptability, Feasibility, and Effectiveness of Internet-Based Cognitive-Behavioral Therapy for Obsessive-Compulsive Disorder in New York. [2020]

5. England pubmed.ncbi.nlm.nih.gov

"Living more and struggling less": a qualitative descriptive study of patient experiences of physiotherapy informed by Acceptance and Commitment Therapy within a multidisciplinary pain management programme. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

[Placebo and nocebo effects on itch : Methodological and clinical implications]. [2019]

7. Singapore pubmed.ncbi.nlm.nih.gov

Recent advances in pathophysiology and current management of itch. [2020]

8. Sweden pubmed.ncbi.nlm.nih.gov

Placebo Effects of Open-label Verbal Suggestions on Itch. [2018]

9. Netherlands pubmed.ncbi.nlm.nih.gov

A new chronic itch model accompanied by skin lesions in hairless mice. [2013]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Open- and Closed-Label Nocebo and Placebo Suggestions on Itch and Itch Expectations. [2020]

11. England 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. [2021]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Cognitive behavioural therapy monotherapy for insomnia: A meta-analysis of randomized controlled trials. [2020]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of internet-based CBT-I for the treatment of chronic subthreshold to moderate insomnia. [2023]

14. Canada pubmed.ncbi.nlm.nih.gov

Mobile App Use for Insomnia Self-Management: Pilot Findings on Sleep Outcomes in Veterans. [2020]