Managing anxiety to improve asthma treatment adherence

Remote Management Strategies and Adherence Improvement for Anxiety-related ICS Resistance in Asthma Patients: an Open-label, Multicenter, Randomized Controlled Trial

This study is testing whether a personalized phone program that helps manage anxiety can improve medication use in adults with asthma who struggle to take their inhalers regularly.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 216 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: First Affiliated Hospital of Ningbo University (Research network)
• Locations: 11 sites (Harbin and 10 other locations)
• Trial ID: NCT06732141 on ClinicalTrials.gov

What this trial studies

The Remote Anxiety Management for ICS-resistant Asthma Study (RAMICS) aims to enhance medication adherence and manage anxiety in asthma patients who struggle with inhaled corticosteroid (ICS) use due to anxiety. This multicenter, open-label, randomized controlled trial will enroll 216 adult participants with poor ICS adherence and clinically significant anxiety. Participants will receive personalized telephone-based interventions, including medication education, progressive muscle relaxation, motivational interviewing, and lung rehabilitation guidance, compared to standard care with weekly follow-up calls.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with asthma who have been on ICS therapy for at least six months and experience clinically significant anxiety.

Not a fit: Patients with acute asthma exacerbations or those not experiencing anxiety related to ICS use may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly improve asthma management and quality of life for patients who are anxious about their medication.

How similar studies have performed: While there is limited data on similar approaches, the integration of psychological support in chronic disease management has shown promise in other contexts.

Eligibility criteria

Inclusion Criteria:

1. Age Requirement:

   Participants must be aged 18 to 80 years, ensuring they are adults capable of making decisions and responding effectively to interventions.
2. Diagnosed Asthma:

   1. 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.
   2. 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.
3. ICS Treatment History:

   1. Participants must have been on inhaled corticosteroid (ICS) therapy for at least six months, ensuring sufficient treatment history for adherence and effect evaluation.
   2. No major changes to asthma control medication regimen in the past six months, ensuring adherence and intervention outcomes are not confounded by treatment changes.
4. Poor Medication Adherence:

   Identified using the Medication Adherence Report Scale (MARS-10), with an average score \<4.5, indicating suboptimal adherence.
5. Presence of Anxiety Symptoms:

   1. Confirmed through the Hamilton Anxiety Rating Scale (HAMA), with a score ≥14, indicating clinically significant anxiety.
   2. 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.
6. Ability to Communicate by Phone:

   Participants must have stable access to a phone and be willing to engage in telephone-based psychological interventions.
7. Stable Health Condition:

Asthma status must be stable, with no acute exacerbations or significant changes in the past month.

Exclusion Criteria:

1. Severe Psychiatric or Cognitive Disorders:

   1. 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.
   2. Presence of cognitive impairments or neurological conditions, such as dementia or post-stroke complications, that may affect comprehension or adherence to the intervention.
   3. Current psychiatric treatment involving antipsychotics, antidepressants, or sedatives that could interfere with the intervention's outcomes.
2. 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.
3. Severe Comorbidities:

   1. 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.
   2. Chronic diseases requiring long-term systemic corticosteroid therapy, such as rheumatic or autoimmune diseases, that may interfere with ICS treatment and study outcomes.
4. Pregnancy or Lactation:

   Pregnant or breastfeeding women are excluded due to the unclear risks of ICS treatment and anxiety management interventions in these populations.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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.

Where this trial is running

Harbin and 10 other locations

• Second Affiliated Hospital of Harbin Medical University — Harbin, China (Recruiting)
• Anhui Chest Hospital — Hefei, China (Recruiting)
• The First Affiliated Hospital of Anhui Medical University — Hefei, China (Recruiting)
• The Second Affiliated Hospital of Anhui Medical University — Hefei, China (Recruiting)
• Jingzhou Central Hospital — Jingzhou, China (Recruiting)
• Haishu District People's Hospital — Ningbo, China (Not_yet_recruiting)
• Ningbo Medical Center Lihuili Hospital — Ningbo, China (Recruiting)
• Qianhu Hospital — Ningbo, China (Recruiting)
• The First Affiliated Hospital of Ningbo University — Ningbo, China (Recruiting)
• Ninghai County First Hospital — Ninghai, China (Recruiting)
• Taizhou Central Hospital — Taizhou, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Chao Cao

Conditions Asthma