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Completed

NCT Number: NCT03486756

Internet-delivered CBT for Asthma-related Anxiety: Feasibility

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).

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Key information

Conditions

Asthma Anxiety Disorders Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Mental Disorders Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Medical Epidemiology and Biostatistics, Karolinska Institutet

Stockholm, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Internet-CBT for anxiety-related asthma

Behavioral

The specific assignments in the intervention will be based on individual behavior analysis for each participant.

Primary outcomes

  1. Catastrophizing about asthma Scale

    Time frame: 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 outcomes

  1. Penn State Worry Questionnaire

    Time frame: 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.

  2. Asthma control test

    Time frame: 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.

  3. Asthma Quality of Life Questionnaire

    Time frame: 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.

  4. Short Health Anxiety Inventory (SHAI)

    Time frame: 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.

  5. Perceived Stress Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Apr 3, 2018
Registry last updated
Dec 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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