Clinical trial NCT03513965: Allergy Experience Study
Official title: Changing Mindsets About Oral Immunotherapy for Peanut Allergies Via Informing Patients That Symptoms Are a Sign of Treatment Efficacy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peanut Allergy
Keywords: food allergy
oral immunotherapy
mindsets
patient experience
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-05-02
Enrollment: 50
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

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.

Primary outcomes:
measure: Anxiety about symptoms
timeFrame: Throughout 7 months of treatment
measure: Occurrence of non-life-threatening symptoms
timeFrame: Throughout 7 months of treatment
measure: Treatment completion
timeFrame: Up to 6 months and 2 weeks after the first clinic visit
measure: Treatment adherence
timeFrame: Throughout 7 months of treatment
measure: Change in peanut blood IgG4 levels
timeFrame: Change from baseline IgG4 levels after 6 months of treatment
measure: Change in peanut blood IgE levels
timeFrame: Change from baseline IgE levels after 6 months of treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Stanford University
name: Alia J Crum, PhD
role: PRINCIPAL_INVESTIGATOR
References: