Internet-delivered CBT for Anxiety Related to Asthma

Not Applicable

Active, not recruiting

• Conditions: Asthma; Anxiety

• Registration Number: NCT04230369
• Lead Sponsor: Karolinska Institutet

Brief Summary

This is a randomized controlled trial to investigate efficacy of a internet-delivered CBT for anxiety related to asthma.

Detailed Description

Asthma is one of the most common chronic diseases and is often associated with anxiety. In a two prior studies (ClinicalTrials.gov ID: NCT03158194; NCT03486756) a protocol for exposure-based cognitive behaviour therapy (CBT) for anxiety related to asthma was developed, and standardised to an internet-delivered format and tested for feasibility and acceptability as an internet-CBT. The aim of the current study is to evaluate the efficacy of exposure-based Internet-CBT for anxiety related to asthma compared to Treatment as Usual (TAU). The plan is to include 90 participants consecutively during 2020.

Study Timeline

• Study First Submitted: 2019-12-20
• Study First Submitted QC: 2020-01-14
• Study First Posted: 2020-01-18
• Study Start: 2020-02-11
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-18
• Primary Completion: 2024-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• asthma diagnosed by a physician
• worry about asthma or limitations in daily life due to asthma at

Exclusion Criteria

• a serious psychiatric condition; e.g., suicidality, psychosis or severe substance addiction
• chronic obstructive pulmonary disease (COPD) or other chronic airway disorders other than asthma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Catastrophizing about asthma Scale	Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.	Change in catastrophizing cognitions about asthma measured with a self-rating scale at baseline, weekly during treatment, at 16 weeks, 36 weeks and 12 months for analysis of effect.

Secondary Outcome Measures

Name	Time	Method
Asthma Behaviour Checklist	Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.	Change in behaviour related to asthma anxiety measured with a self-rating scale at baseline, weekly during treatment, at 16 weeks, 36 weeks and 12 months for analysis of effect.
Insomnia Severity Index	Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.	Change in insomnia measured with a self-rating scale at baseline, at 16 weeks, 36 weeks and 12 months for analysis of effect.
Penn State Worry Questionnaire	Time Frame: Baseline to 8 weeks; baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.	Change in subjective worry measured with a self-rating scale measured with a self-rating scale at baseline, at 16 weeks, 36 weeks and 12 months for analysis of effect.
Asthma Quality of Life Questionnaire	Time Frame: Baseline to 8 weeks; baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.	Change in asthma-related quality of life measured with a self-rating scale at baseline, at 16 weeks, 36 weeks and 12 months for analysis of effect.
Perceived Stress Scale	Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.	Change in perceived stress measured with a self-rating scale at baseline, weekly during treatment, at 16 weeks, 36 weeks and 12 months for analysis of effect.
Asthma control test	Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.	Change in asthma control measured with a self-rating scale at baseline, weekly during treatment, at 16 weeks, 36 weeks and 12 months for analysis of effect.
Fear of Asthma Symptoms	Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.	Change in fear of asthma symptoms measured with a self-rating scale at baseline, weekly during treatment, at 16 weeks, 36 weeks and 12 months for analysis of effect.
Asthma Tuner	Time Frame: Baseline to 8 weeks; baseline to16 weeks.	Change in FEV1 measured with a digital spirometer at baseline, posttreatment and at 16 weeks.
Short Health Anxiety Inventory (SHAI)	Time Frame: Baseline to 8 weeks; baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.	Change in health anxiety measured with a self-rating scale at baseline, at 16 weeks, 36 weeks and 12 months for analysis of effect.
Patient Health Questionnaire-9	Time Frame: Baseline to 8 weeks; baseline to16 weeks; baseline to 36 weeks; baseline to 12 months.	Change in depression measured with a self-rating scale at baseline, at 16 weeks, 36 weeks and 12 months for analysis of effect.
WHODAS	Time Frame: Baseline to 8 weeks; Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.	Change in health related quality of life for health economic evaluation measured with a self-rating scale at baseline, at 16 weeks, 36 weeks and 12 months for analysis of effect.
Brunnsviken quality of life scale	Time Frame: Baseline to 8 weeks; baseline to16 weeks; baseline to 36 weeks; baseline to 12 months.	Change in general quality of life measured with a self-rating scale at baseline, at 16 weeks, 36 weeks and 12 months for analysis of effect.
Treatment Inventory of Costs in Patients	Time Frame: Baseline to 8 weeks; baseline to16 weeks; baseline to 36 weeks; baseline to 12 months.	Change in health consumption measured with a self-rating scale at baseline, postreatment and at 16 weeks for analysis of effect.

Trial Locations

Locations (1)

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