Internet-delivered CBT for Anxiety Related to Asthma

NCT ID: NCT04230369

Last Updated: 2024-06-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-11
• Study Completion Date: 2025-09-30

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.

Conditions

Asthma; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Exposure-based Internet-CBT

Intervention Type: 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.

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.

Group Type: OTHER

Treatment as usual

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Other Intervention Names

Online exposure therapy; TAU

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Catarina Almqvist Malmros

Professor, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Catarina A Almqvist, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Department of Medical Epidemiology and Biostatistics, Karolinska Institutet

Stockholm, , Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 38802281 (View on PubMed)

Other Identifiers

MANTRA03

Identifier Type: -

Identifier Source: org_study_id