Internet-delivered CBT for Asthma-related Anxiety: Feasibility

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Behavioral: Internet-CBT for anxiety-related asthma

• Registration Number: NCT03486756
• Lead Sponsor: Karolinska Institutet

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-03-27
• Study First Submitted QC: 2018-04-02
• Study First Posted: 2018-04-03
• Study Start: 2018-04-16
• Primary Completion: 2018-12-20
• Study Completion: 2019-04-25
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-10
• Last Update Posted: 2019-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• asthma diagnosed by a physician
• anxiety or stress related to asthma

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Exclusion Criteria

• severe psychiatric disorder
• chronic obstructive pulmonary disease (COPD) and other chronic airway disorders other than asthma

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Internet-CBT	Internet-CBT for anxiety-related asthma	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.

Primary Outcome Measures

Name	Time	Method
Catastrophizing about asthma Scale	Baseline to 8 weeks; baseline to 16 weeks; baseline to 24 weeks.	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Medical Epidemiology and Biostatistics, Karolinska Institutet; 🇸🇪 Stockholm, Sweden