Allergy Experience Study

NCT ID: NCT03513965

Last Updated: 2018-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-05
• Study Completion Date: 2018-07-01

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.

Conditions

Peanut Allergy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Symptoms as Side Effects Mindset

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Symptoms as Positive Signals Mindset

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Alia Crum

Assistant Professor of Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alia J Crum, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Other Identifiers

36282

Identifier Type: -

Identifier Source: org_study_id