Internet-delivered CBT for Anxiety Related to Asthma

NCT04230369 | Active Not Recruiting

• 1 other identifier: MANTRA03
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthma; Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Asthma control test

  Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.

• Penn State Worry Questionnaire

  Time Frame: Baseline to 8 weeks; baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.

• Asthma Quality of Life Questionnaire

  Time Frame: Baseline to 8 weeks; baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.

• Short Health Anxiety Inventory (SHAI)

  Time Frame: Baseline to 8 weeks; baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.

• Perceived Stress Scale

  Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.

Study Arms (2)

Internet-CBT

EXPERIMENTAL

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

Treatment as usual

OTHER

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

Interventions

Exposure-based Internet-CBT BEHAVIORAL

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.

Also known as: Online exposure therapy

Internet-CBT

Treatment as usual OTHER

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.

Also known as: TAU

Treatment as usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• asthma diagnosed by a physician
• worry about asthma or limitations in daily life due to asthma at

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Department of Medical Epidemiology and Biostatistics, Karolinska Institutet

Stockholm, Sweden

Location

Related Publications (2)

• Bonnert M, Nash S, Andersson EM, Bergstrom SEE, Gorling J 1, Janson C, Sarnholm J, Almqvist C. Online cognitive behaviour therapy for asthma-related anxiety: a randomised controlled trial. Thorax. 2026 Jan 6:thorax-2025-223886. doi: 10.1136/thorax-2025-223886. Online ahead of print.

  PMID: 41494908 DERIVED

• Bonnert M, Nash S, Andersson EM, Bergstrom SE, Janson C, Almqvist C. Internet-delivered cognitive-behaviour therapy for anxiety related to asthma: study protocol for a randomised controlled trial. BMJ Open Respir Res. 2024 May 27;11(1):e002035. doi: 10.1136/bmjresp-2023-002035.

  PMID: 38802281 DERIVED

MeSH Terms

Conditions

Asthma; Anxiety Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Mental Disorders

Study Officials

• Catarina A Almqvist, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All assessments will be conducted by participants over the internet, why there can be no influence from study staff during data collection.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD

Model Details: The participants will be randomised to immediate internet-CBT or 4 months of treatment as usual before cross-over to internet-CBT.

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: January 18, 2020
• Study Start: February 11, 2020
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2025
• Last Updated: June 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)