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New treatment option for Asthma
Official title Remote Anxiety Management for ICS-resistant Asthma Study
ClinicalTrials.gov ID: NCT06732141
What this study is testing
- What it's testing
- This study, the Remote Anxiety Management for ICS-resistant Asthma Study (RAMICS), explores strategies to improve medication adherence and anxiety management in asthma patients who are resistant to using inhaled corticosteroids (ICS) due to anxiety. Asthma is a chronic respiratory disease affecting millions worldwide, and ICS therapy is essential for controlling symptoms and preventing severe exacerbations.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Age Requirement: Participants must be aged 18 to 80 years, ensuring they are adults capable of making decisions and responding effectively to...
- Diagnosed Asthma:
- Diagnosis must meet the criteria of the Global Initiative for Asthma (GINA) or the American Academy of Asthma guidelines, with at least one confirmed...
- Asthma severity must range from mild to moderate persistent, in the chronic management phase, excluding patients in acute exacerbation phases for...
- ICS Treatment History:
You likely can't join if
- Severe Psychiatric or Cognitive Disorders:
- Diagnosis of major psychiatric disorders, such as major depressive disorder, bipolar disorder, schizophrenia, or other severe mental illnesses within...
- Presence of cognitive impairments or neurological conditions, such as dementia or post-stroke complications, that may affect comprehension or...
- Current psychiatric treatment involving antipsychotics, antidepressants, or sedatives that could interfere with the intervention's outcomes.
- Substance Abuse or Dependence: History of alcohol or drug abuse within the past six months, including but not limited to opioids, benzodiazepines, or...
- Severe Comorbidities:
See the full eligibility criteria
Who can join
- Age Requirement: Participants must be aged 18 to 80 years, ensuring they are adults capable of making decisions and responding effectively to interventions.
- Diagnosed Asthma:
- Diagnosis must meet the criteria of the Global Initiative for Asthma (GINA) or the American Academy of Asthma guidelines, with at least one confirmed diagnosis by a specialist in the past six months.
- Asthma severity must range from mild to moderate persistent, in the chronic management phase, excluding patients in acute exacerbation phases for clearer evaluation of adherence and intervention effects.
- ICS Treatment History:
- Participants must have been on inhaled corticosteroid (ICS) therapy for at least six months, ensuring sufficient treatment history for adherence and effect evaluation.
- No major changes to asthma control medication regimen in the past six months, ensuring adherence and intervention outcomes are not confounded by treatment changes.
- Poor Medication Adherence: Identified using the Medication Adherence Report Scale (MARS-10), with an average score \<4.5, indicating suboptimal adherence.
- Presence of Anxiety Symptoms:
- Confirmed through the Hamilton Anxiety Rating Scale (HAMA), with a score ≥14, indicating clinically significant anxiety.
- Anxiety symptoms must be related to asthma treatment, particularly concerns about ICS side effects or long-term use, ensuring the psychological intervention targets relevant issues.
- Ability to Communicate by Phone: Participants must have stable access to a phone and be willing to engage in telephone-based psychological interventions.
- Stable Health Condition: Asthma status must be stable, with no acute exacerbations or significant changes in the past month.
What rules you out
- Severe Psychiatric or Cognitive Disorders:
- Diagnosis of major psychiatric disorders, such as major depressive disorder, bipolar disorder, schizophrenia, or other severe mental illnesses within the past six months, based on DSM-5 criteria.
- Presence of cognitive impairments or neurological conditions, such as dementia or post-stroke complications, that may affect comprehension or adherence to the intervention.
- Current psychiatric treatment involving antipsychotics, antidepressants, or sedatives that could interfere with the intervention's outcomes.
- Substance Abuse or Dependence: History of alcohol or drug abuse within the past six months, including but not limited to opioids, benzodiazepines, or illicit substances.
- Severe Comorbidities:
- Uncontrolled respiratory or cardiovascular conditions, such as chronic obstructive pulmonary disease (COPD), bronchiectasis, interstitial lung disease, heart failure, or uncontrolled hypertension, that could...
- Chronic diseases requiring long-term systemic corticosteroid therapy, such as rheumatic or autoimmune diseases, that may interfere with ICS treatment and study outcomes.
- Pregnancy or Lactation: Pregnant or breastfeeding women are excluded due to the unclear risks of ICS treatment and anxiety management interventions in these populations.
- Allergic Bronchopulmonary Aspergillosis (ABPA) or Related Conditions: Diagnosed ABPA or other respiratory diseases with mechanisms distinct from asthma, which could confound the assessment of ICS treatment effects.
- Participation in Other treatment Clinical Trials: Participation in another treatment clinical trial within the past three months, particularly those involving respiratory diseases or medication adherence management, to...
- Incompatibility with Telephone-Based Interventions: Inability to reliably receive or engage in telephone-based psychological interventions due to hearing impairments, communication barriers, or other reasons.
- Adverse Reactions to Psychological Interventions: Documented refusal of or adverse reactions to psychological interventions, such as phone-based relaxation or motivational interviewing, that could affect the feasibility...
- History of Major Surgery or Hospitalization: History of major surgery or hospitalization (unrelated to asthma) within the past six months that might impact current health status and introduce bias into the study...
The study team makes the final eligibility decision.
Where it's taking place
- Harbin, China
- Hefei, China
- Jingzhou, China
- Ningbo, China
- Ninghai, China
- Taizhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Harbin, China; Hefei, China; Jingzhou, China; Ningbo, China; Ninghai, China; Taizhou, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.