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Completed

NCT Number: NCT03158194

Cognitive Behavior Therapy for Anxiety-related Asthma in Adults.

This is a study to develop a protocol on Cognitive behavior therapy (CBT) for asthma-related anxiety that in a consecutive study can be translated to internet-delivered CBT.

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Key information

Age range

18 year and older

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. Cognitive behaviour therapy (CBT) has been shown to increase psychological well-being for anxiety-related asthma. Our primary aim is to develop a standardized CBT protocol for asthma-related anxiety that can be transferred to internet-delivered CBT. Ten participants will be included in a single-subject multiple baseline design. They will all receive 10-12 sessions of CBT.

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 (e.g. psychotic disorder, addiction disorder, suicidal ideation).

Treatment and study plan

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. Penn State Worry Questionnaire

    Time frame: Baseline to 12 weeks

    Change in subjective worry measured with a self-rating scale weekly during 1-3 weeks at baseline and at 10 to 12 weeks post treatment for analysis of effect.

Secondary outcomes

  1. Anxiety Sensitivity Index-3

    Time frame: Baseline to 12 weeks

    Change in anxiety sensitivity measured with a self-rating scale weekly during 1-3 weeks at baseline and at 10 to 12 weeks post treatment for analysis of effect.

  2. Short Health Anxiety Inventory (SHAI)

    Time frame: Baseline to 12 weeks

    Change in health anxiety measured with a self-rating scale weekly during 1-3 weeks at baseline and at 10 to 12 weeks post treatment for analysis of effect.

  3. Asthma Quality of Life Questionnaire

    Time frame: Baseline to 12 weeks

    Change in asthma-related quality of life measured with a self-rating scale at pretreatment and at 10 to 12 weeks post treatment for analysis of effect.

  4. Asthma control test

    Time frame: Baseline to 12 weeks

    Change in asthma control measured with a self-rating scale daily during weekly 1-3 weeks at baseline and at 10 to 12 weeks post treatment for analysis of effect.

  5. Catastrophizing about asthma Scale

    Time frame: Baseline to 12 weeks

    Change in catastrophizing cognitions about asthma measured with a self-rating scale weekly during 1-3 weeks at baseline and at 10 to 12 weeks post treatment for analysis of effect.

  6. Perceived Stress Scale

    Time frame: Baseline to 12 weeks

    Change in perceived stress measured with a self-rating scale weekly 1-3 weeks at baseline and at 10 to 12 weeks post treatment for analysis of effect.

  7. Patient Health Questionnaire

    Time frame: Baseline to 12 weeks

    Change in depression measured with a self-rating scale at baseline and at 10 to 12 weeks post treatment for analysis of effect.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 18, 2017
Registry last updated
Mar 8, 2018

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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