Internet-delivered CBT for Anxiety Related to Asthma

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

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

Study Overview

• Status: Recruiting
• Conditions: Asthma; Anxiety
• Intervention / Treatment: Behavioral: Exposure-based Internet-CBT; Other: Treatment as usual

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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marianne Bonnert, PhD; Phone Number: +4673482864; Email: marianne.bonnert@ki.se

Study Locations

• Sweden
  • Stockholm, Sweden
    • Recruiting
    • Department of Medical Epidemiology and Biostatistics, Karolinska Institutet
    • Contact: Catarina Almqvist Malmros, PhD; Email: Catarina.Almqvist@ki.se
    • Contact: Marianne Bonnert, PhD; Email: marianne.bonnert@ki.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Internet-CBT; 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; 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 Names: Online exposure therapy
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, 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; 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.; Other Names: TAU

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Catarina A Almqvist, PhD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: December 20, 2019
• First Submitted That Met QC Criteria: January 14, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): September 15, 2022
• Last Update Submitted That Met QC Criteria: September 14, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Anxiety Disorders; Asthma
• Other Study ID Numbers: MANTRA03

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