Internet-delivered CBT for Asthma-related Anxiety: Feasibility

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03486756
• Other study ID #: MANTRA02
• Status: Completed
• Phase: N/A
• Start date: April 16, 2018
• Est. completion date: April 25, 2019

Study information

• Verified date: December 2019
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 25, 2019
• Est. primary completion date: December 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• Internet-CBT for anxiety-related asthma
The specific assignments in the intervention will be based on individual behavior analysis for each participant.

Locations

Country	Name	City	State
Sweden	Department of Medical Epidemiology and Biostatistics, Karolinska Institutet	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.