NCT03513965

Allergy Experience Study

Changing Mindsets About Oral Immunotherapy for Peanut Allergies Via Informing Patients That Symptoms Are a Sign of Treatment Efficacy: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 7 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peanut Allergy

Interventions

Type	Name	Description
BEHAVIORAL	Symptoms as Positive Signals Mindset	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.
BEHAVIORAL	Symptoms as Side Effects Mindset	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.

Timeline

• Start date: 2017-01-05
• Primary completion: 2017-08-03
• Completion: 2018-07-01
• First posted: 2018-05-02
• Last updated: 2018-08-07