AsthmaNCT03486756
Internet-delivered CBT for Asthma-related Anxiety: Feasibility
A study testing Internet-CBT for anxiety-related asthma in people with Asthma, run by Karolinska Institutet at 1 site in Sweden.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- Internet-CBT for anxiety-related asthma
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 16 Apr 2018to 25 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- asthma diagnosed by a physician
- anxiety or stress related to asthma
Who cannot join
- severe psychiatric disorder
- chronic obstructive pulmonary disease (COPD) and other chronic airway disorders other than asthma
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Medical Epidemiology and Biostatistics, Karolinska Institutet
Stockholm
About this study
Official title: Internet-delivered Cognitive Behavior Therapy for Asthma-related Anxiety: A Feasibility Study
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.
- Conditions
- Asthma
- Being tested
- Internet-CBT for anxiety-related asthma
- Keywords
- Asthma, Anxiety, Stress
- Medical subject headings
- Asthma, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-CBT for anxiety-related asthmaBehavioural
The specific assignments in the intervention will be based on individual behavior analysis for each participant.
| Study group | Role | What they receive |
|---|---|---|
| Internet-CBT | Experimental | 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. Receives: Behavioral: Internet-CBT for anxiety-related asthma |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 8 weeks; baseline to 16 weeks; baseline to 24 weeks.
Secondary outcomes (5)
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.
Measured: Baseline to 8 weeks; baseline to 16 weeks; baseline to 24 weeks.
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.
Measured: Baseline to 8 weeks; baseline to 16 weeks; baseline to 24 weeks.
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.
Measured: Baseline to 8 weeks; baseline to 16 weeks; baseline to 24 weeks.
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.
Measured: Baseline to 8 weeks; baseline to 16 weeks; baseline to 24 weeks.
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.
Measured: Baseline to 8 weeks; baseline to 16 weeks; baseline to 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start16 Apr 2018
- Primary completion20 Dec 2018
- Study completion25 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an uncontrolled feasibility study with one arm.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catarina Almqvist Malmros, Karolinska Institutet
- Investigators
- Catarina Almqvist Malmros, MD PhD, Principal investigator, Department of Medical Epidemiology and Biostatistics, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03486756
- Sponsor's protocol ID
- MANTRA02
- Status last verified
- Dec 2019
- First submitted
- 27 Mar 2018
- Last updated
- 11 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-delivered Cognitive Behavior Therapy for Asthma-related Anxiety: A Feasibility Study
- ClinicalTrials.gov ID
- NCT03486756
- Acronym / sponsor ID
- MANTRA02
- Conditions
- Asthma
- Keywords
- Asthma, Anxiety, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 16 Apr 2018 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 25 Apr 2019 (actual)
- First posted
- 3 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an uncontrolled feasibility study with one arm.
| Arm | Type | Receives |
|---|---|---|
| Internet-CBT | Experimental | Behavioral: Internet-CBT for anxiety-related asthmaInternet-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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- asthma diagnosed by a physician
- anxiety or stress related to asthma
Key exclusion criteria (2 listed)
- severe psychiatric disorder
- chronic obstructive pulmonary disease (COPD) and other chronic airway disorders other than asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-CBT for anxiety-related asthmaThe specific assignments in the intervention will be based on individual behavior analysis for each participant. | Behavioural | Internet-CBT |
Primary outcome
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.
5 secondary outcomes
Penn State Worry Questionnaire
Time frame: Baseline to 8 weeks; baseline to 16 weeks; baseline to 24 weeks.
Asthma control test
Time frame: Baseline to 8 weeks; baseline to 16 weeks; baseline to 24 weeks.
Asthma Quality of Life Questionnaire
Time frame: Baseline to 8 weeks; baseline to 16 weeks; baseline to 24 weeks.
Short Health Anxiety Inventory (SHAI)
Time frame: Baseline to 8 weeks; baseline to 16 weeks; baseline to 24 weeks.
Perceived Stress Scale
Time frame: Baseline to 8 weeks; baseline to 16 weeks; baseline to 24 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
- Derived from this study: PubMed 34401374Bonnert 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catarina Almqvist Malmros, MD PhD principal investigator
Department of Medical Epidemiology and Biostatistics, Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-CBT for anxiety-related asthma in people with Asthma, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Catastrophizing about asthma Scale (time frame: Baseline to 8 weeks; baseline to 16 weeks; baseline to 24 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03486756, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2019.