Internet-delivered CBT for Asthma-related Anxiety: Feasibility

Not Applicable

Completed

• Conditions: 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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