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Mental Health ConditionsNCT06623799

Impact of Help-Seeking Behaviors on Allergic Rhinitis and Mental Health: A Longitudinal Study

An observational study of Mental Health Conditions and Allergic, run by QHSLab, Inc. at 1 site in United States.

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Sites and contacts
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Trial summary

This study explores how help-seeking behaviors for both emotional well-being and allergies impact the management of allergic rhinitis, asthma, and mental health symptoms, including anxiety and depression. Read more about this study

Who is it for?
Ages 4 to 100 yearsHealthy volunteers can take part
Conditions the study is for
Mental Health Conditions, Allergic
How many people
200,000 participants
Where
1 siteUnited States
Study dates
1 Jan 2020to 25 Jan 2027
How long will I take part?
10 Years
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: This repository collects data from primary care patients diagnosed with allergic rhinitis, asthma, anxiety, or depression. The repository aims to track health outcomes, medication usage, and help-seeking behaviors to support future research on the interaction between chronic physical and mental health conditions. The population includes adult patients who consent to the inclusion of their data and who seek care in a primary care setting for the specified conditions.

Who may be able to join

  • Adults (aged 18 years or older) Patients actively receiving care in a primary care setting. Patients who have provided informed consent for their health data to be included in the research repository.

Who cannot join

  • Patients who have not provided informed consent for their health data to be included in the research repository.
  • Patients diagnosed with chronic conditions outside the scope of allergic rhinitis, asthma, or mental health conditions (anxiety, depression).
  • Patients with severe mental health disorders or comorbidities that are unrelated to the conditions of interest (e.g., schizophrenia, bipolar disorder, etc.).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Marcos A Sanchez-Gonzalez, MD, PhD contact

850-559-7676

masanchez@qhslab.com

Troy Grogan contact

troy.grogan@usaqcorp.com

United States1 site, 1 recruiting
  • QHSLab

    West Palm Beach, Florida, 33407

    Marcos A Sanchez-Gonzalez, MD, PhD, 8505597676, masanchez@qhslab.com

    Troy Grogan, (929) 379-6503, troy.grogan@usaqcorp.com

    Recruiting

Other trials in United States

About this study

Official title: Impact of Help-Seeking Behaviors on Allergic Rhinitis, Asthma Control, and Mental Health: A Retrospective and Longitudinal Analysis of Allergy Medication Use

This study explores how help-seeking behaviors for both emotional well-being and allergies impact the management of allergic rhinitis, asthma, and mental health symptoms, including anxiety and depression. The research involves a retrospective and longitudinal analysis of patients who sought treatment for allergic rhinitis and mental health concerns. The goal is to highlight the importance of integrating mental health care into allergy treatment plans to improve overall patient outcomes.

Read the detailed description

This study aims to investigate the impact of help-seeking behaviors (HSB) on allergic rhinitis (AR), asthma control, and mental health outcomes, such as anxiety and depression, using both retrospective and longitudinal data. The study examines patients who have been diagnosed with AR and mental health conditions to assess how seeking professional help for allergies, emotional well-being, or both influences symptom control and quality of life.

The research analyzes data from a diverse patient population to evaluate the effects of AR medications (intranasal steroids, antihistamines, decongestants, and leukotriene blockers) on both AR and mental health symptoms. Additionally, it explores the role of help-seeking behaviors in improving symptom management, specifically through the use of validated tools like the SNOT-22 for AR and the PHQ-GAD16 for mental health.

The study emphasizes the importance of integrating mental health screening and support into the treatment of allergic rhinitis and asthma. By analyzing real-world data, the research seeks to provide insights into how coordinated care approaches can enhance patient outcomes and inform future clinical practices.

Keywords
Allergic Rhinitis, Asthma Control, Mental Health, Help-Seeking Behaviors, Integrated Care
Medical subject headings
Rhinitis, Allergic, Psychological Well-Being, Help-Seeking Behavior

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Allergic Rhinitis Symptom Severity (SNOT-22 Score)

    This outcome measures the long-term change in allergic rhinitis symptom severity over several years using the Sinonasal Outcome Test (SNOT-22). The SNOT-22 is a validated tool that assesses the impact of sinonasal conditions on quality of life. The study will track the effects of help-seeking behaviors for both allergies and mental health (anxiety and depression) on allergic rhinitis symptom control, examining changes in SNOT-22 scores over multiple follow-up periods. Scores range from 0 to 110, with higher scores indicating worse symptoms and lower quality of life.

    Measured: baseline and yearly follow-up for up to 5 years

Secondary outcomes (2)
  1. Change in Depression Symptoms (PHQ-9 Score)

    This outcome measures the change in depressive symptoms using the Patient Health Questionnaire (PHQ-9). The PHQ-9 is a validated tool to assess the severity of depression. Scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. The study will assess how help-seeking behaviors for both allergies and mental health impact the severity of depressive symptoms over time.

    Measured: Baseline and yearly follow-up for up to 5 years

  2. Change in Anxiety Symptoms (GAD-7 Score)

    This outcome measures the change in anxiety symptoms using the Generalized Anxiety Disorder Scale (GAD-7). The GAD-7 is a validated tool to assess the severity of anxiety. Scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms. The study will assess how help-seeking behaviors for both allergies and mental health impact the severity of anxiety symptoms over time.

    Measured: Baseline and yearly follow-up for up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2024
  2. Study start1 Jan 2020
  3. Primary completion25 Jan 2027 (estimated)
  4. Study completion25 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrolment
200,000 participants (estimated)
Target duration
10 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06623799
Sponsor's protocol ID
QHSLab 001-2024
Status last verified
Feb 2026
First submitted
13 Sep 2024
Last updated
11 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared due to privacy concerns and the need to protect patient confidentiality. Data collected in this study is used for internal analysis, and only aggregated, anonymized data will be made available for research purposes. This ensures compliance with privacy regulations such as HIPAA and protects patient identities.

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