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.
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
- Are there results?
- Not yet: the study is under way
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.
Troy Grogan contact
United States1 site, 1 recruiting
- 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
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.
- Conditions
- Mental Health Conditions, Allergic
- 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.
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)
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
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.
- First posted2 Oct 2024
- Study start1 Jan 2020
- Primary completion25 Jan 2027 (estimated)
- Study completion25 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- QHSLab, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Help-Seeking Behaviors on Allergic Rhinitis, Asthma Control, and Mental Health: A Retrospective and Longitudinal Analysis of Allergy Medication Use
- ClinicalTrials.gov ID
- NCT06623799
- Acronym / sponsor ID
- QHSLab 001-2024
- Conditions
- Mental Health Conditions, Allergic
- Keywords
- Allergic Rhinitis, Asthma Control, Mental Health, Help-Seeking Behaviors, Integrated Care
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200,000 participants (estimated)
- Lead sponsor
- QHSLab, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 25 Jan 2027 (estimated)
- Study completion
- 25 Jan 2027 (estimated)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 4 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Allergic Rhinitis Symptom Severity (SNOT-22 Score)
Time frame: baseline and yearly follow-up for up to 5 years
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.
2 secondary outcomes
Change in Depression Symptoms (PHQ-9 Score)
Time frame: Baseline and yearly follow-up for up to 5 years
Change in Anxiety Symptoms (GAD-7 Score)
Time frame: Baseline and yearly follow-up for up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Troy Grogan contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health Conditions and Allergic, run by QHSLab, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marcos A Sanchez-Gonzalez, MD, PhD (850-559-7676, masanchez@qhslab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Allergic Rhinitis Symptom Severity (SNOT-22 Score) (time frame: baseline and yearly follow-up for up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.