ClinicalTrials.gg
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

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

Where this study stands

Counted across the records on this site · 2026-11-13

Among 15 studies in Asthma by Karolinska Institutet — 2 open to participants now, 5 under way, none of them phase 3. Asthma · Karolinska Institutet.

Enrollment
11th of 14
30 · median 50
Started
2018
the only one that year
No phase
12 of 15
1 open now
Registered
8th of 15
by date

Among the 15 studies in Asthma by Karolinska Institutet, this one is the 11th largest by enrollment of the 14 interventional ones that give a count, is the only one that started in 2018, is one of 12 with no phase, and was the 8th registered.

Asthma

4,843 studies on the registry are indexed under Asthma; 602 are open to participants now.

Browse Asthma studies →

Open to participants now

2 of the 15 studies in Asthma by Karolinska Institutet are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 2 open studies →

Where they have run

Who these studies take

Of the 417 Asthma studies recruiting now, 140 (34%) set no upper age limit and 205 (49%) stop at 75 or younger; 146 take children under 18; 104 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 15 studies in Asthma by Karolinska Institutet, or all of them as a file.
02

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.

03

Conditions studied

  • Asthma

Keywords

  • Asthma
  • Anxiety
  • Stress
04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • severe psychiatric disorder
  • (COPD) and other chronic airway disorders other than asthma
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

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.

06

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.

07

Study locations

1 site
  • Department of Medical Epidemiology and Biostatistics, Karolinska Institutet
    Stockholm, Sweden
08

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

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2018 to primary completion in Dec 2018, 8 months.

Of 599 non-industry interventional studies with no phase under Asthma, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 50. This study's 8 months is below that.

Counting every sponsor, half of 649 studies reached it within 23 months; a quarter within 10 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 27, 2018
First posted
Apr 3, 2018
StartActual
Apr 16, 2018
Primary completionActual
Dec 20, 2018
CompletionActual
Apr 25, 2019
Last update
Dec 11, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 11, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03486756
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 ↗

Not currently enrolling

This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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