Back to resultsInternet-delivered CBT for Anxiety Related to Asthma
Primary Purpose
Asthma, Anxiety
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Exposure-based Internet-CBT
Treatment as usual
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
Eligibility Criteria
Inclusion Criteria:
- asthma diagnosed by a physician
- worry about asthma or limitations in daily life due to asthma at
Exclusion Criteria:
- 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
Sites / Locations
- Department of Medical Epidemiology and Biostatistics, Karolinska InstitutetRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Internet-CBT
Treatment as usual
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Asthma Tuner
Change in FEV1 measured with a digital spirometer at baseline, posttreatment and at 16 weeks.
Full Information
NCT ID
NCT04230369
First Posted
December 20, 2019
Last Updated
September 14, 2022
Sponsor
Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT04230369
Brief Title
Internet-delivered CBT for Anxiety Related to Asthma
Official Title
Internet-delivered Cognitive Behaviour Therapy for Anxiety Related to Asthma: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 11, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
Outcomes Assessor
Masking Description
All assessments will be conducted by participants over the internet, why there can be no influence from study staff during data collection.
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Internet-CBT
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as usual
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exposure-based Internet-CBT
Other Intervention Name(s)
Online exposure therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment as usual
Other Intervention Name(s)
TAU
Intervention Description
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.
Primary Outcome Measure Information:
Title
Catastrophizing about asthma Scale
Description
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.
Time Frame
Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
Secondary Outcome Measure Information:
Title
Asthma control test
Description
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.
Time Frame
Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
Title
Penn State Worry Questionnaire
Description
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.
Time Frame
Time Frame: Baseline to 8 weeks; baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
Title
Asthma Quality of Life Questionnaire
Description
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.
Time Frame
Time Frame: Baseline to 8 weeks; baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
Title
Short Health Anxiety Inventory (SHAI)
Description
Change in health anxiety measured with a self-rating scale at baseline, at 16 weeks, 36 weeks and 12 months for analysis of effect.
Time Frame
Time Frame: Baseline to 8 weeks; baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
Title
Perceived Stress Scale
Description
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.
Time Frame
Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
Title
Fear of Asthma Symptoms
Description
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.
Time Frame
Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
Title
Asthma Behaviour Checklist
Description
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.
Time Frame
Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
Title
Insomnia Severity Index
Description
Change in insomnia measured with a self-rating scale at baseline, at 16 weeks, 36 weeks and 12 months for analysis of effect.
Time Frame
Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
Title
Patient Health Questionnaire-9
Description
Change in depression measured with a self-rating scale at baseline, at 16 weeks, 36 weeks and 12 months for analysis of effect.
Time Frame
Time Frame: Baseline to 8 weeks; baseline to16 weeks; baseline to 36 weeks; baseline to 12 months.
Title
WHODAS
Description
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.
Time Frame
Time Frame: Baseline to 8 weeks; Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
Title
Brunnsviken quality of life scale
Description
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.
Time Frame
Time Frame: Baseline to 8 weeks; baseline to16 weeks; baseline to 36 weeks; baseline to 12 months.
Title
Treatment Inventory of Costs in Patients
Description
Change in health consumption measured with a self-rating scale at baseline, postreatment and at 16 weeks for analysis of effect.
Time Frame
Time Frame: Baseline to 8 weeks; baseline to16 weeks; baseline to 36 weeks; baseline to 12 months.
Title
Asthma Tuner
Description
Change in FEV1 measured with a digital spirometer at baseline, posttreatment and at 16 weeks.
Time Frame
Time Frame: Baseline to 8 weeks; baseline to16 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
asthma diagnosed by a physician
worry about asthma or limitations in daily life due to asthma at
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marianne Bonnert, PhD
Phone
+4673482864
Email
marianne.bonnert@ki.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catarina A Almqvist, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medical Epidemiology and Biostatistics, Karolinska Institutet
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catarina Almqvist Malmros, PhD
Email
Catarina.Almqvist@ki.se
First Name & Middle Initial & Last Name & Degree
Marianne Bonnert, PhD
Email
marianne.bonnert@ki.se
12. IPD Sharing Statement
Plan to Share IPD
No
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Internet-delivered CBT for Anxiety Related to Asthma
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