AsthmaNCT04230369
Internet-delivered CBT for Anxiety Related to Asthma
A study testing Exposure-based Internet-CBT and Treatment as usual in people with Asthma and Anxiety, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
This is a randomized controlled trial to investigate efficacy of a internet-delivered CBT for anxiety related to asthma. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Exposure-based Internet-CBT and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSweden
- Study dates
- 11 Feb 2020to 30 Sep 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- asthma diagnosed by a physician
- worry about asthma or limitations in daily life due to asthma at
Who cannot join
- a serious psychiatric condition; e.g., suicidality, psychosis or severe substance addiction
- chronic obstructive pulmonary disease (COPD) or 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 Behaviour Therapy for Anxiety Related to Asthma: A Randomized Controlled Trial
This is a randomized controlled trial to investigate efficacy of a internet-delivered CBT for anxiety related to asthma.
Read the detailed description
Asthma is one of the most common chronic diseases and is often associated with anxiety. In a two prior studies (ClinicalTrials.gov ID: NCT03158194; NCT03486756) a protocol for exposure-based cognitive behaviour therapy (CBT) for anxiety related to asthma was developed, and standardised to an internet-delivered format and tested for feasibility and acceptability as an internet-CBT. The aim of the current study is to evaluate the efficacy of exposure-based Internet-CBT for anxiety related to asthma compared to Treatment as Usual (TAU). The plan is to include 90 participants consecutively during 2020.
- Being tested
- Exposure-based Internet-CBT, Treatment as usual
- 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.
Exposure-based Internet-CBTBehavioural
Also called Online exposure therapy
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. All participants in both conditions can use any other available treatment (TAU), but psychological, from pre-assessments to 2 months after treatment completion.
Treatment as usualOther
Also called TAU
Patients randomized to treatment as usual will receive the same medical information that participants in the Internet-CBT get, with physiological information about asthma and the importance of medical adherence to achieve well controlled asthma, but without the exposure-based treatment and no therapist support. All participants in both conditions can use any other available treatment (TAU), but psychological, from pre-assessments to 2 months after treatment completion.
| Study group | Role | What they receive |
|---|---|---|
| Internet-CBT | Experimental | The internet-CBT will comprise 8 weekly modules with therapist-support, encouraging exposure for fear of asthma symptoms while ensuring a stable asthma medication through a written medical plan on medical adherence Participants work independently from home with the treatment and receive weekly support from their psychologist through written messages online. Receives: Behavioral: Exposure-based Internet-CBT |
| Treatment as usual | Other | Patients randomized to treatment as usual will receive the same medical information that participants in the Internet-CBT get, with physiological information about asthma and the importance of medical adherence to achieve well controlled asthma, but without the exposure-based treatment and no therapist support. All participants in both conditions can use any other available treatment, but psychological, from pre-assessments to 2 months after treatment completion. Participants in this arm will be crossed over to Internet-CBT after the primary endpoint at to 2 months follow up. Receives: Other: Treatment as usual |
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, weekly during treatment, at 16 weeks, 36 weeks and 12 months for analysis of effect.
Measured: Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
Secondary outcomes (13)
Asthma control test
Change in asthma control measured with a self-rating scale at baseline, weekly during treatment, at 16 weeks, 36 weeks and 12 months for analysis of effect.
Measured: Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
Penn State Worry Questionnaire
Change in subjective worry measured with a self-rating scale measured with a self-rating scale at baseline, at 16 weeks, 36 weeks and 12 months for analysis of effect.
Measured: Time Frame: Baseline to 8 weeks; baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
Asthma Quality of Life Questionnaire
Change in asthma-related quality of life measured with a self-rating scale at baseline, at 16 weeks, 36 weeks and 12 months for analysis of effect.
Measured: Time Frame: Baseline to 8 weeks; baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
Short Health Anxiety Inventory (SHAI)
Change in health anxiety measured with a self-rating scale at baseline, at 16 weeks, 36 weeks and 12 months for analysis of effect.
Measured: Time Frame: Baseline to 8 weeks; baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
Perceived Stress Scale
Change in perceived stress measured with a self-rating scale at baseline, weekly during treatment, at 16 weeks, 36 weeks and 12 months for analysis of effect.
Measured: Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
Fear of Asthma Symptoms
Change in fear of asthma symptoms measured with a self-rating scale at baseline, weekly during treatment, at 16 weeks, 36 weeks and 12 months for analysis of effect.
Measured: Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
Asthma Behaviour Checklist
Change in behaviour related to asthma anxiety measured with a self-rating scale at baseline, weekly during treatment, at 16 weeks, 36 weeks and 12 months for analysis of effect.
Measured: Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
Insomnia Severity Index
Change in insomnia measured with a self-rating scale at baseline, at 16 weeks, 36 weeks and 12 months for analysis of effect.
Measured: Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
Patient Health Questionnaire-9
Change in depression measured with a self-rating scale at baseline, at 16 weeks, 36 weeks and 12 months for analysis of effect.
Measured: Time Frame: Baseline to 8 weeks; baseline to16 weeks; baseline to 36 weeks; baseline to 12 months.
WHODAS
Change in health related quality of life for health economic evaluation measured with a self-rating scale at baseline, at 16 weeks, 36 weeks and 12 months for analysis of effect.
Measured: Time Frame: Baseline to 8 weeks; Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
Brunnsviken quality of life scale
Change in general quality of life measured with a self-rating scale at baseline, at 16 weeks, 36 weeks and 12 months for analysis of effect.
Measured: Time Frame: Baseline to 8 weeks; baseline to16 weeks; baseline to 36 weeks; baseline to 12 months.
Treatment Inventory of Costs in Patients
Change in health consumption measured with a self-rating scale at baseline, postreatment and at 16 weeks for analysis of effect.
Measured: Time Frame: Baseline to 8 weeks; baseline to16 weeks; baseline to 36 weeks; baseline to 12 months.
Asthma Tuner
Change in FEV1 measured with a digital spirometer at baseline, posttreatment and at 16 weeks.
Measured: Time Frame: Baseline to 8 weeks; baseline to16 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start11 Feb 2020
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Randomised
- Intervention model
- Crossover
- Model description
- The participants will be randomised to immediate internet-CBT or 4 months of treatment as usual before cross-over to internet-CBT.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 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 A Almqvist, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04230369
- Sponsor's protocol ID
- MANTRA03
- Status last verified
- Jun 2024
- First submitted
- 20 Dec 2019
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bonnert M, Nash S, Andersson EM, Bergstrom SEE, Gorling J 1, Janson C, Sarnholm J, Almqvist C. Online cognitive behaviour therapy for asthma-related anxiety: a randomised controlled trial. Thorax. 2026 Jul 15;81(8):766-773. doi: 10.1136/thorax-2025-223886.
PubMed 41494908Bonnert M, Nash S, Andersson EM, Bergstrom SE, Janson C, Almqvist C. Internet-delivered cognitive-behaviour therapy for anxiety related to asthma: study protocol for a randomised controlled trial. BMJ Open Respir Res. 2024 May 27;11(1):e002035. doi: 10.1136/bmjresp-2023-002035.
PubMed 38802281
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-delivered Cognitive Behaviour Therapy for Anxiety Related to Asthma: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04230369
- Acronym / sponsor ID
- MANTRA03
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 11 Feb 2020 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 18 Jan 2020 (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 randomized controlled trial to investigate efficacy of a internet-delivered CBT for anxiety related to asthma.
Detailed description
Asthma is one of the most common chronic diseases and is often associated with anxiety. In a two prior studies (ClinicalTrials.gov ID: NCT03158194; NCT03486756) a protocol for exposure-based cognitive behaviour therapy (CBT) for anxiety related to asthma was developed, and standardised to an internet-delivered format and tested for feasibility and acceptability as an internet-CBT. The aim of the current study is to evaluate the efficacy of exposure-based Internet-CBT for anxiety related to asthma compared to Treatment as Usual (TAU). The plan is to include 90 participants consecutively during 2020.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The participants will be randomised to immediate internet-CBT or 4 months of treatment as usual before cross-over to internet-CBT.
| Arm | Type | Receives |
|---|---|---|
| Internet-CBT | Experimental | Behavioral: Exposure-based Internet-CBTThe internet-CBT will comprise 8 weekly modules with therapist-support, encouraging exposure for fear of asthma symptoms while ensuring a stable asthma medication through a written medical plan on medical adherence Participants work independently from home with the treatment and receive weekly support from their psychologist through written messages online. |
| Treatment as usual | Other | Other: Treatment as usualPatients randomized to treatment as usual will receive the same medical information that participants in the Internet-CBT get, with physiological information about asthma and the importance of medical adherence to achieve well controlled asthma, but without the exposure-based treatment and no therapist support. All participants in both conditions can use any other available treatment, but psychological, from pre-assessments to 2 months after treatment completion. Participants in this arm will be crossed over to Internet-CBT after the primary endpoint at to 2 months follow up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- asthma diagnosed by a physician
- worry about asthma or limitations in daily life due to asthma at
Key exclusion criteria (2 listed)
- a serious psychiatric condition; e.g., suicidality, psychosis or severe substance addiction
- chronic obstructive pulmonary disease (COPD) or 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 |
|---|---|---|
| Exposure-based Internet-CBTAlso: Online exposure therapyInternet-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. All participants in both conditions can use any other available treatment (TAU), but psychological, from pre-assessments to 2 months after treatment completion. | Behavioural | Internet-CBT |
| Treatment as usualAlso: TAUPatients randomized to treatment as usual will receive the same medical information that participants in the Internet-CBT get, with physiological information about asthma and the importance of medical adherence to achieve well controlled asthma, but without the exposure-based treatment and no therapist support. All participants in both conditions can use any other available treatment (TAU), but psychological, from pre-assessments to 2 months after treatment completion. | Other | Treatment as usual |
Primary outcome
Catastrophizing about asthma Scale
Time frame: Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
Change in catastrophizing cognitions about asthma measured with a self-rating scale at baseline, weekly during treatment, at 16 weeks, 36 weeks and 12 months for analysis of effect.
13 secondary outcomes
Asthma control test
Time frame: Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
Penn State Worry Questionnaire
Time frame: Time Frame: Baseline to 8 weeks; baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
Asthma Quality of Life Questionnaire
Time frame: Time Frame: Baseline to 8 weeks; baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
Short Health Anxiety Inventory (SHAI)
Time frame: Time Frame: Baseline to 8 weeks; baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
Perceived Stress Scale
Time frame: Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
Fear of Asthma Symptoms
Time frame: Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
Asthma Behaviour Checklist
Time frame: Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
Insomnia Severity Index
Time frame: Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
Patient Health Questionnaire-9
Time frame: Time Frame: Baseline to 8 weeks; baseline to16 weeks; baseline to 36 weeks; baseline to 12 months.
WHODAS
Time frame: Time Frame: Baseline to 8 weeks; Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
Brunnsviken quality of life scale
Time frame: Time Frame: Baseline to 8 weeks; baseline to16 weeks; baseline to 36 weeks; baseline to 12 months.
Treatment Inventory of Costs in Patients
Time frame: Time Frame: Baseline to 8 weeks; baseline to16 weeks; baseline to 36 weeks; baseline to 12 months.
Asthma Tuner
Time frame: Time Frame: Baseline to 8 weeks; baseline to16 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Derived from this study: PubMed 41494908Bonnert M, Nash S, Andersson EM, Bergstrom SEE, Gorling J 1, Janson C, Sarnholm J, Almqvist C. Online cognitive behaviour therapy for asthma-related anxiety: a randomised controlled trial. Thorax. 2026 Jul 15;81(8):766-773. doi: 10.1136/thorax-2025-223886.
- Derived from this study: PubMed 38802281Bonnert M, Nash S, Andersson EM, Bergstrom SE, Janson C, Almqvist C. Internet-delivered cognitive-behaviour therapy for anxiety related to asthma: study protocol for a randomised controlled trial. BMJ Open Respir Res. 2024 May 27;11(1):e002035. doi: 10.1136/bmjresp-2023-002035.
- 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 A Almqvist, PhD principal investigator
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 Exposure-based Internet-CBT and Treatment as usual in people with Asthma and Anxiety, 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: status not confirmed, as of the sponsor's last update on 18 Jun 2024. 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?
Results are not available in the source record.
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: Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.). 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 NCT04230369, which also lists 2 linked publications.
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 18 Jun 2024.