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CompletedNCT03486756Updated Dec 11, 2019

Internet-delivered CBT for Asthma-related Anxiety: Feasibility

An interventional study of Internet-CBT for anxiety-related asthma in Asthma, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-12-11.

Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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).

Read the detailed 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.

02

Conditions studied

  • Asthma

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Keywords

  • Asthma
  • Anxiety
  • Stress
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • asthma diagnosed by a physician
  • anxiety or stress related to asthma

Exclusion criteria

Exclusion Criteria:

  • severe psychiatric disorder
  • chronic obstructive pulmonary disease (COPD) and other chronic airway disorders other than asthma
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Internet-CBT

    Internet-CBT for anxiety-related asthma 8 weekly modules of CBT delivered over the internet and targeting enhanced function and decreased symptoms of anxiety. Participants work independently from home with the treatment and receive support from experienced Internet-CBT Psychologists through written messages in the secure platform.

    Behavioral: Internet-CBT for anxiety-related asthma

Interventions

  • BehavioralInternet-CBT for anxiety-related asthma

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

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline to 8 weeks; baseline to 16 weeks; baseline to 24 weeks.

Secondary outcomes

  1. 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.

    Time frame: Baseline to 8 weeks; baseline to 16 weeks; baseline to 24 weeks.

  2. 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.

    Time frame: Baseline to 8 weeks; baseline to 16 weeks; baseline to 24 weeks.

  3. 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.

    Time frame: Baseline to 8 weeks; baseline to 16 weeks; baseline to 24 weeks.

  4. 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.

    Time frame: Baseline to 8 weeks; baseline to 16 weeks; baseline to 24 weeks.

  5. 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.

    Time frame: Baseline to 8 weeks; baseline to 16 weeks; baseline to 24 weeks.

06

Study locations

1 site
  • Department of Medical Epidemiology and Biostatistics, Karolinska Institutet
    Stockholm, Sweden
07

References and documents

Publications

  • Bonnert M, Sarnholm J, Andersson E, Bergstrom SE, Lalouni M, Lundholm C, Serlachius E, Almqvist C. Targeting excessive avoidance behavior to reduce anxiety related to asthma: A feasibility study of an exposure-based treatment delivered online. Internet Interv. 2021 Jun 17;25:100415. doi: 10.1016/j.invent.2021.100415. eCollection 2021 Sep. PubMed 34401374 ↗

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT03486756
Lead sponsor
Karolinska Institutet
Responsible party
Catarina Almqvist Malmros (Professor, Karolinska Institutet) — Principal investigator
First posted
Apr 3, 2018
Start date
Apr 16, 2018
Primary completion
Dec 20, 2018
Completion
Apr 25, 2019
Last update
Dec 11, 2019

Study contacts

Catarina Almqvist Malmros, MD PhD
principal investigator · Department of Medical Epidemiology and Biostatistics, Karolinska Institutet

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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