- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03486756
Internet-delivered CBT for Asthma-related Anxiety: Feasibility
December 10, 2019 updated by: Catarina Almqvist Malmros, Karolinska Institutet
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Stockholm, Sweden
- Department of Medical Epidemiology and Biostatistics, Karolinska Institutet
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- asthma diagnosed by a physician
- anxiety or stress related to asthma
Exclusion Criteria:
- severe psychiatric disorder
- chronic obstructive pulmonary disease (COPD) and other chronic airway disorders other than asthma
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
The specific assignments in the intervention will be based on individual behavior analysis for each participant.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline to 8 weeks; baseline to 16 weeks; baseline to 24 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Penn State Worry Questionnaire
Time Frame: Baseline to 8 weeks; baseline to 16 weeks; baseline to 24 weeks.
|
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.
|
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.
|
Change in asthma control measured with a self-rating scale at baseline, 8 weeks, 16 weeks and 24 weeks for analysis of effect.
|
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.
|
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.
|
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.
|
Change in health anxiety measured with a self-rating scale at baseline, 8 weeks, 16 weeks and 24 weeks for analysis of effect.
|
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.
|
Change in perceived stress measured with a self-rating scale at baseline, 8 weeks, 16 weeks and 24 weeks for analysis of effect.
|
Baseline to 8 weeks; baseline to 16 weeks; baseline to 24 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Catarina Almqvist Malmros, MD PhD, Department of Medical Epidemiology and Biostatistics, Karolinska Institutet
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 16, 2018
Primary Completion (Actual)
December 20, 2018
Study Completion (Actual)
April 25, 2019
Study Registration Dates
First Submitted
March 27, 2018
First Submitted That Met QC Criteria
April 2, 2018
First Posted (Actual)
April 3, 2018
Study Record Updates
Last Update Posted (Actual)
December 11, 2019
Last Update Submitted That Met QC Criteria
December 10, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MANTRA02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Asthma
-
Vanderbilt University Medical CenterNot yet recruitingAsthma in Children | Asthma Attack | Asthma Acute | Acute Asthma Exacerbation | Asthma; StatusUnited States
-
University of California, San FranciscoCompletedAsthma in Children | Asthma Attack | Asthma Acute | Asthma ChronicUnited States
-
SingHealth PolyclinicsNot yet recruitingAsthma | Asthma in Children | Asthma Attack | Asthma Acute | Asthma Chronic
-
Johann Wolfgang Goethe University HospitalCompleted
-
Universita di VeronaCompleted
-
Parc de Salut MarActive, not recruitingAsthma in Children | Persistent Asthma | Asthma ExacerbationSpain
-
Forest LaboratoriesCompleted
-
Brunel UniversityKarolinska InstitutetUnknown
-
Value Outcomes Ltd.AstraZenecaCompletedAsthma, Bronchial | Bronchial Asthma | Asthma Chronic | Asthma; EosinophilicCzechia
Clinical Trials on Internet-CBT for anxiety-related asthma
-
Karolinska InstitutetCompleted
-
University of HaifaLinkoeping University; Hebrew University of JerusalemCompleted
-
Linkoeping UniversityCompletedDepression | Anxiety DisordersSweden
-
Karolinska InstitutetRegion StockholmCompleted
-
Karolinska InstitutetRegion StockholmCompletedInsomnia | Major Depression | Minor DepressionSweden
-
Kaiser PermanenteOregon Health and Science UniversityCompleted
-
Seattle Children's HospitalUniversity of VirginiaActive, not recruitingMigraine Disorders | Insomnia | Headache DisordersUnited States
-
Anglia Ruskin UniversityLinkoeping UniversityCompletedTinnitusUnited Kingdom
-
Karolinska InstitutetCompletedBody Dysmorhpic DisorderSweden
-
Ersta Sköndal University CollegeKarolinska Institutet; Region StockholmCompletedInsomnia | Bereavement