Internet-delivered CBT for Anxiety Related to Asthma

Not Applicable

Active, not recruiting

• Conditions: Asthma; Anxiety
• Interventions: Other: Treatment as usual; Behavioral: Exposure-based Internet-CBT

• 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment as usual	Treatment as usual	Patients randomized to treatment as usual will receive the same medical information that participants in the Internet-CBT get, with physiological information about asthma and the importance of medical adherence to achieve well controlled asthma, but without the exposure-based treatment and no therapist support. All participants in both conditions can use any other available treatment, but psychological, from pre-assessments to 2 months after treatment completion. Participants in this arm will be crossed over to Internet-CBT after the primary endpoint at to 2 months follow up.
Internet-CBT	Exposure-based Internet-CBT	The internet-CBT will comprise 8 weekly modules with therapist-support, encouraging exposure for fear of asthma symptoms while ensuring a stable asthma medication through a written medical plan on medical adherence Participants work independently from home with the treatment and receive weekly support from their psychologist through written messages online.

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