Internet-delivered CBT for Anxiety Related to Asthma

Study Overview
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Brief Summary
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This is a randomized controlled trial to investigate efficacy of a internet-delivered CBT for anxiety related to asthma.

Detailed Description
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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.

Official Title
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Internet-delivered Cognitive Behaviour Therapy for Anxiety Related to Asthma: A Randomized Controlled Trial

Conditions
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Asthma, Anxiety

Intervention / Treatment
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* Behavioral: Exposure-based Internet-CBT
* Other: Treatment as usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-CBT<br>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. | Behavioral: Exposure-based Internet-CBT<br>* 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.<br>* Other names: Online exposure therapy;|
| Other: Treatment as usual<br>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. | Other: Treatment as usual<br>* 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.<br>* Other names: TAU;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Time Frame: Baseline to 8 weeks; baseline to16 weeks. |