Internet-delivered CBT for Asthma-related Anxiety: Feasibility

Study Overview
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Brief Summary
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This is a study to investigate acceptability and feasibility of a novel protocol on exposure-based CBT for asthma-related fear delivered over the Internet (Internet-CBT).

Detailed Description
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Asthma is one of the most common chronic diseases around the world, with a high prevalence of anxiety disorders. In a prior study (ClinicalTrials.gov ID: NCT03158194) a protocol for exposure-based CBT was developed for asthma-related anxiety. The aim of the current study is to evaluate acceptability and feasibility of our protocol for asthma-related fear when delivered over the Internet (Internet-CBT). The plan is to include 30 participants that will all receive the intervention in this uncontrolled feasibility study.

Official Title
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Internet-delivered Cognitive Behavior Therapy for Asthma-related Anxiety: A Feasibility Study

Conditions
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Asthma

Intervention / Treatment
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* Behavioral: Internet-CBT for anxiety-related asthma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: asthma diagnosed by a physician anxiety or stress related to asthma Exclusion Criteria: severe psychiatric disorder chronic obstructive pulmonary disease (COPD) and other chronic airway disorders other than asthma

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is an uncontrolled feasibility study with one arm.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-CBT<br>Internet-CBT for anxiety-related asthma 8 weekly modules of CBT delivered over the internet and targeting enhanced function and decreased symptoms of anxiety. Participants work independently from home with the treatment and receive support from experienced Internet-CBT Psychologists through written messages in the secure platform. | Behavioral: Internet-CBT for anxiety-related asthma<br>* The specific assignments in the intervention will be based on individual behavior analysis for each participant.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Catastrophizing about asthma Scale | Change in catastrophizing cognitions about asthma measured with a self-rating scale at baseline, 8 weeks, 16 weeks and 24 weeks for analysis of effect. | Baseline to 8 weeks; baseline to 16 weeks; baseline to 24 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Penn State Worry Questionnaire | Change in subjective worry measured with a self-rating scale measured with a self-rating scale at baseline, 8 weeks, 16 weeks and 24 weeks for analysis of effect. | Baseline to 8 weeks; baseline to 16 weeks; baseline to 24 weeks. | 
| Asthma control test | Change in asthma control measured with a self-rating scale at baseline, 8 weeks, 16 weeks and 24 weeks for analysis of effect. | Baseline to 8 weeks; baseline to 16 weeks; baseline to 24 weeks. | 
| Asthma Quality of Life Questionnaire | Change in asthma-related quality of life measured with a self-rating scale at baseline, 8 weeks, 16 weeks and 24 weeks for analysis of effect. | Baseline to 8 weeks; baseline to 16 weeks; baseline to 24 weeks. | 
| Short Health Anxiety Inventory (SHAI) | Change in health anxiety measured with a self-rating scale at baseline, 8 weeks, 16 weeks and 24 weeks for analysis of effect. | Baseline to 8 weeks; baseline to 16 weeks; baseline to 24 weeks. | 
| Perceived Stress Scale | Change in perceived stress measured with a self-rating scale at baseline, 8 weeks, 16 weeks and 24 weeks for analysis of effect. | Baseline to 8 weeks; baseline to 16 weeks; baseline to 24 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Anxiety, Stress