Remote Anxiety Management for ICS-resistant Asthma Study

Inclusion criteria

• 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.

Exclusion criteria

• 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 significantly impact asthma control and overall health.
• 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 Interventional Clinical Trials:

Participation in another interventional clinical trial within the past three months, particularly those involving respiratory diseases or medication adherence management, to avoid confounding effects on outcomes.

• 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 and effectiveness of the study.

• 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 outcomes.