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Completed

NCT Number: NCT03513965

Allergy Experience Study

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.

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Key information

Conditions

Peanut Allergy Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nut and Peanut Hypersensitivity Peanut Hypersensitivity

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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:

  • Decrease anxiety about symptoms,
  • Increase treatment completion,
  • Decrease the likelihood of participants reducing dose size or skipping a dose because of anxiety about symptoms,
  • Reduce the experience of non-life-threatening symptoms during the study, and
  • Improve physiological treatment outcomes at the conclusion of the study, as measured through peanut blood IgG4 and IgE levels.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Symptoms as Positive Signals Mindset

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.

Symptoms as Side Effects Mindset

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.

Primary outcomes

  1. Anxiety about symptoms

    Time frame: Throughout 7 months of treatment

    Measured through daily REDCap surveys and monthly in clinic surveys; measured through parent contacting staff with concerns about symptoms

  2. Occurrence of non-life-threatening symptoms

    Time frame: Throughout 7 months of treatment

    Measured through daily REDCap surveys

  3. Treatment completion

    Time frame: 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

  4. Treatment adherence

    Time frame: Throughout 7 months of treatment

    Number of doses skipped or reduced because of anxiety

  5. Change in peanut blood IgG4 levels

    Time frame: Change from baseline IgG4 levels after 6 months of treatment

    Two blood samples assayed for IgG4 levels; one pre-treatment and one post-treatment

  6. Change in peanut blood IgE levels

    Time frame: Change from baseline IgE levels after 6 months of treatment

    Two blood samples assayed for IgE levels; one pre-treatment and one post-treatment

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
May 2, 2018
Registry last updated
Aug 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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