Allergy Experience Study
Condition: Peanut Allergy
MeSH terms: Hypersensitivity; Peanut Hypersensitivity
Study type: Interventional

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.
    

Intervention name(s): Symptoms as Positive Signals Mindset; Symptoms as Side Effects Mindset
Intervention type(s): Behavioral; Behavioral
Intervention description(s): In this intervention, both arms receive the same strategies for managing symptoms and receive the same level of support regarding symptoms. However, Symptoms as Positive Signals Mindset families are additionally encouraged to think of symptoms as a positive signal that their immune system is becoming increasingly desensitized to their allergen. For each arm, four families (six to seven patients per group) meet monthly for eight months in the clinic with at least two members of the patient support team. These visits are an opportunity for families to harness peer support and ask questions, and include a variety of activities that depict symptoms in different ways.; In this intervention, both arms receive the same strategies for managing symptoms and receive the same level of support regarding symptoms. For each arm, four families (six to seven patients per group) meet monthly for eight months in the clinic with at least two members of the patient support team. These visits are an opportunity for families to harness peer support and ask questions, and include a variety of activities that depict symptoms in different ways.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: food allergy; oral immunotherapy; mindsets; patient experience