Internet-delivered CBT for Anxiety Related to Asthma

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04230369
• Other study ID #: MANTRA03
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 11, 2020
• Est. completion date: September 30, 2025

Study information

• Verified date: June 2024
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Asthma

Intervention

Behavioral:
• Exposure-based 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. 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
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.

Locations

Country	Name	City	State
Sweden	Department of Medical Epidemiology and Biostatistics, Karolinska Institutet	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.