AsthmaNCT03158194
Cognitive Behavior Therapy for Anxiety-related Asthma in Adults.
A study testing 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 develop a protocol on Cognitive behavior therapy (CBT) for asthma-related anxiety that in a consecutive study can be translated to internet-delivered CBT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- 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
- 6 participants
- Where
- 1 siteSweden
- Study dates
- 16 Aug 2017to 7 Mar 2018
- 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
- anxiety or stress related to asthma
Who cannot join
- severe psychiatric disorder (e.g. psychotic disorder, addiction disorder, suicidal ideation).
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Medical Epidemiology and Biostatistics, Karolinska Institutet
Stockholm
About this study
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.
Read the detailed description
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.
- Conditions
- Asthma
- Being tested
- CBT for anxiety-related asthma
- Keywords
- Anxiety, Stress, Asthma
- 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.
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 |
|---|---|---|
| CBT for anxiety-related asthma | Experimental | Ten to twelve weekly sessions of CBT targeting enhanced function and decreased symptoms of anxiety. Receives: Behavioral: CBT for anxiety-related asthma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Penn State Worry Questionnaire
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.
Measured: Baseline to 12 weeks
Secondary outcomes (7)
Anxiety Sensitivity Index-3
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.
Measured: Baseline to 12 weeks
Short Health Anxiety Inventory (SHAI)
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.
Measured: Baseline to 12 weeks
Asthma Quality of Life Questionnaire
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.
Measured: Baseline to 12 weeks
Asthma control test
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.
Measured: Baseline to 12 weeks
Catastrophizing about asthma Scale
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.
Measured: Baseline to 12 weeks
Perceived Stress Scale
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.
Measured: Baseline to 12 weeks
Patient Health Questionnaire
Change in depression measured with a self-rating scale at baseline and at 10 to 12 weeks post treatment for analysis of effect.
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study start16 Aug 2017
- Primary completion7 Mar 2018
- Study completion7 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single-subject multiple baseline design.
- Masking
- None (open label)
- Enrolment
- 6 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
- NCT03158194
- Sponsor's protocol ID
- MANTRA 01
- Status last verified
- Mar 2018
- First submitted
- 16 May 2017
- Last updated
- 8 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavior Therapy for Anxiety-related Asthma in Adults.
- ClinicalTrials.gov ID
- NCT03158194
- Acronym / sponsor ID
- MANTRA 01
- Conditions
- Asthma
- Keywords
- Anxiety, Stress, Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 16 Aug 2017 (actual)
- Primary completion
- 7 Mar 2018 (actual)
- Study completion
- 7 Mar 2018 (actual)
- First posted
- 18 May 2017 (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 develop a protocol on Cognitive behavior therapy (CBT) for asthma-related anxiety that in a consecutive study can be translated to internet-delivered CBT.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-subject multiple baseline design.
| Arm | Type | Receives |
|---|---|---|
| CBT for anxiety-related asthma | Experimental | Behavioral: CBT for anxiety-related asthmaTen to twelve weekly sessions of CBT targeting enhanced function and decreased symptoms of anxiety. |
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
- anxiety or stress related to asthma
Key exclusion criteria (1 listed)
- severe psychiatric disorder (e.g. psychotic disorder, addiction disorder, suicidal ideation).
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 |
|---|---|---|
| CBT for anxiety-related asthmaThe specific assignments in the intervention will be based on individual behavior analysis for each participant. | Behavioural | CBT for anxiety-related asthma |
Primary outcome
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.
7 secondary outcomes
Anxiety Sensitivity Index-3
Time frame: Baseline to 12 weeks
Short Health Anxiety Inventory (SHAI)
Time frame: Baseline to 12 weeks
Asthma Quality of Life Questionnaire
Time frame: Baseline to 12 weeks
Asthma control test
Time frame: Baseline to 12 weeks
Catastrophizing about asthma Scale
Time frame: Baseline to 12 weeks
Perceived Stress Scale
Time frame: Baseline to 12 weeks
Patient Health Questionnaire
Time frame: Baseline to 12 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 8 Mar 2018.
- 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 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 1 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 8 Mar 2018. 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?
Penn State Worry Questionnaire (time frame: Baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Mar 2018.