Allergy Experience Study

Not Applicable

Completed

• Conditions: Peanut Allergy
• Interventions: Behavioral: Symptoms as Side Effects Mindset; Behavioral: Symptoms as Positive Signals Mindset

• Registration Number: NCT03513965
• Lead Sponsor: Stanford University

Brief Summary

People who are undergoing oral immunotherapy for food allergy treatment can feel anxious about the treatment process, particularly when they have allergic responses (e.g., hives, vomiting, nausea) during the dosing process. People may commonly believe that these symptoms are simply side effects that must be endured or avoided. However, the investigators propose that changing participants' mindsets about the meaning of symptoms-toward viewing them as a sign that the treatment is working and desensitization is increasing-during the treatment process will reduce anxiety and improve treatment outcomes.

Detailed Description

Participants: The investigators will recruit participants who will receive treatment for peanut allergies through oral immunotherapy at the Sean N. Parker Center for Allergy \& Asthma Research.

Procedures: The investigators will divide recruited participants into two groups (random assignment). Each group will receive different messages about oral immunotherapy, one defined as "Symptoms as Side Effects Mindset" (in which symptoms are described as an unfortunate side effect of treatment). The other group will receive messages that help foster a "Symptoms as Positive Signals Mindset" (in which symptoms are described as a sign of increasing desensitization). These messages will be conveyed verbally and through activities by the study staff and participants will also receive pamphlets emphasizing these messages.

The investigators expect that adopting a "Symptoms as Positive Signals" mindset will improve OIT outcomes in five ways:

1. Decrease anxiety about symptoms,

2. Increase treatment completion,

3. Decrease the likelihood of participants reducing dose size or skipping a dose because of anxiety about symptoms,

4. Reduce the experience of non-life-threatening symptoms during the study, and

5. Improve physiological treatment outcomes at the conclusion of the study, as measured through peanut blood IgG4 and IgE levels.

Study Timeline

• Study Start: 2017-01-05
• Primary Completion: 2017-08-03
• Study First Submitted: 2018-04-12
• Study First Submitted QC: 2018-05-01
• Study First Posted: 2018-05-02
• Study Completion: 2018-07-01
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-06
• Last Update Posted: 2018-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• peanut-specific blood IgE level >=60 Ku/L
• or, if IgE levels <60, need to have a skin prick test greater than 3mm and IgE >5 Ku/L

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Exclusion Criteria

• having previously participated in an OIT treatment or having a family member who had done so (since the study focused on educating participants about OIT)
• being in the updose phase of allergy shots or sublingual therapy
• having been intubated or admitted to an ICU because of allergic reaction
• having a heart disorder
• diagnosed eosinophilic esophagitis
• being on oral steroids or Xolair
• diagnosed anxiety disorders, as we expected this group to have higher baseline anxiety about treatment.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Symptoms as Side Effects Mindset	Symptoms as Side Effects Mindset	Both arms are given identical treatment instructions at their first clinic visit, including practical strategies for taking doses and managing symptoms. Families are given comprehensive instructions for recognizing life-threatening symptoms and administering epinephrine when appropriate. However, information about the implications of non-life-threatening symptoms differs between arms. At the first clinic visit, families are given verbal (e.g., provider explanations) and written information (e.g., brochures on symptom management) informing them about symptoms in different ways. In this arm, families are informed that these non-life-threatening symptoms are an unfortunate part of treatment that must be endured, similar to side effects from common medications.
Symptoms as Positive Signals Mindset	Symptoms as Positive Signals Mindset	Both arms are given identical treatment instructions at their first clinic visit, including practical strategies for taking doses and managing symptoms. Families are given comprehensive instructions for recognizing life-threatening symptoms and administering epinephrine when appropriate. However, information about the implications of non-life-threatening symptoms differs between arms. At the first clinic visit, families are given verbal (e.g., provider explanations) and written information (e.g., brochures on symptom management) informing them about symptoms in different ways. In this arm, families are informed that symptoms are a sign that that their bodies are gradually increasing desensitization, similar to having sore muscles after a difficult workout.

Primary Outcome Measures

Name	Time	Method
Anxiety about symptoms	Throughout 7 months of treatment	Measured through daily REDCap surveys and monthly in clinic surveys; measured through parent contacting staff with concerns about symptoms
Occurrence of non-life-threatening symptoms	Throughout 7 months of treatment	Measured through daily REDCap surveys
Treatment completion	Up to 6 months and 2 weeks after the first clinic visit	Number of patients who complete within 2 weeks of the target end date
Treatment adherence	Throughout 7 months of treatment	Number of doses skipped or reduced because of anxiety
Change in peanut blood IgG4 levels	Change from baseline IgG4 levels after 6 months of treatment	Two blood samples assayed for IgG4 levels; one pre-treatment and one post-treatment
Change in peanut blood IgE levels	Change from baseline IgE levels after 6 months of treatment	Two blood samples assayed for IgE levels; one pre-treatment and one post-treatment