Skip to main content
Clinical Trials/NCT04230369
NCT04230369
Active, not recruiting
Not Applicable

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

Karolinska Institutet1 site in 1 country90 target enrollmentFebruary 11, 2020
ConditionsAsthmaAnxiety

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Asthma
Sponsor
Karolinska Institutet
Enrollment
90
Locations
1
Primary Endpoint
Catastrophizing about asthma Scale
Status
Active, not recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 11, 2020
End Date
September 30, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Catarina Almqvist Malmros

Professor, MD

Karolinska Institutet

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Asthma Behaviour Checklist(Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.)
  • Insomnia Severity Index(Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.)
  • Patient Health Questionnaire-9(Time Frame: Baseline to 8 weeks; baseline to16 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.)
  • Perceived Stress Scale(Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.)
  • Asthma control test(Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.)
  • Fear of Asthma Symptoms(Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.)
  • Asthma Tuner(Time Frame: Baseline to 8 weeks; baseline to16 weeks.)
  • Short Health Anxiety Inventory (SHAI)(Time Frame: Baseline to 8 weeks; baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.)
  • WHODAS(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: Baseline to 8 weeks; baseline to16 weeks; baseline to 36 weeks; baseline to 12 months.)
  • Treatment Inventory of Costs in Patients(Time Frame: Baseline to 8 weeks; baseline to16 weeks; baseline to 36 weeks; baseline to 12 months.)

Study Sites (1)

Loading locations...

Similar Trials