Internet-delivered CBT for Anxiety Related to Asthma

June 17, 2024 updated by: Catarina Almqvist Malmros, Karolinska Institutet

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Sweden
      • Stockholm, Sweden
        • Department of Medical Epidemiology and Biostatistics, Karolinska Institutet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Catastrophizing about asthma Scale
Time Frame: Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Asthma control test
Time Frame: Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
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
Time Frame: Time Frame: Baseline to 8 weeks; baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
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
Time Frame: Time Frame: Baseline to 8 weeks; baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
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)
Time Frame: Time Frame: Baseline to 8 weeks; baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
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
Time Frame: Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
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
Time Frame: Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
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
Time Frame: Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
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
Time Frame: Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
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
Time Frame: Time Frame: Baseline to 8 weeks; baseline to16 weeks; baseline to 36 weeks; baseline to 12 months.
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
Time Frame: Time Frame: Baseline to 8 weeks; Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
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
Time Frame: Time Frame: Baseline to 8 weeks; baseline to16 weeks; baseline to 36 weeks; baseline to 12 months.
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
Time Frame: Time Frame: Baseline to 8 weeks; baseline to16 weeks; baseline to 36 weeks; baseline to 12 months.
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
Time Frame: Time Frame: Baseline to 8 weeks; baseline to16 weeks.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karolinska Institutet

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Catarina A Almqvist, PhD, Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 11, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 20, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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