NCT03486756

Brief Summary

This is a study to investigate acceptability and feasibility of a novel protocol on exposure-based CBT for asthma-related fear delivered over the Internet (Internet-CBT).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 3, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

April 16, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2019

Completed
Last Updated

December 11, 2019

Status Verified

December 1, 2019

Enrollment Period

8 months

First QC Date

March 27, 2018

Last Update Submit

December 10, 2019

Conditions

Keywords

AsthmaAnxietyStress

Outcome Measures

Primary Outcomes (1)

  • Catastrophizing about asthma Scale

    Change in catastrophizing cognitions about asthma measured with a self-rating scale at baseline, 8 weeks, 16 weeks and 24 weeks for analysis of effect.

    Baseline to 8 weeks; baseline to 16 weeks; baseline to 24 weeks.

Secondary Outcomes (5)

  • Penn State Worry Questionnaire

    Baseline to 8 weeks; baseline to 16 weeks; baseline to 24 weeks.

  • Asthma control test

    Baseline to 8 weeks; baseline to 16 weeks; baseline to 24 weeks.

  • Asthma Quality of Life Questionnaire

    Baseline to 8 weeks; baseline to 16 weeks; baseline to 24 weeks.

  • Short Health Anxiety Inventory (SHAI)

    Baseline to 8 weeks; baseline to 16 weeks; baseline to 24 weeks.

  • Perceived Stress Scale

    Baseline to 8 weeks; baseline to 16 weeks; baseline to 24 weeks.

Study Arms (1)

Internet-CBT

EXPERIMENTAL

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.

Behavioral: Internet-CBT for anxiety-related asthma

Interventions

The specific assignments in the intervention will be based on individual behavior analysis for each participant.

Internet-CBT

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • asthma diagnosed by a physician
  • anxiety or stress related to asthma

You may not qualify if:

  • severe psychiatric disorder
  • chronic obstructive pulmonary disease (COPD) and other chronic airway disorders other than asthma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medical Epidemiology and Biostatistics, Karolinska Institutet

Stockholm, Sweden

Location

Related Publications (1)

  • Bonnert M, Sarnholm J, Andersson E, Bergstrom SE, Lalouni M, Lundholm C, Serlachius E, Almqvist C. Targeting excessive avoidance behavior to reduce anxiety related to asthma: A feasibility study of an exposure-based treatment delivered online. Internet Interv. 2021 Jun 17;25:100415. doi: 10.1016/j.invent.2021.100415. eCollection 2021 Sep.

MeSH Terms

Conditions

AsthmaAnxiety Disorders

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesMental Disorders

Study Officials

  • Catarina Almqvist Malmros, MD PhD

    Department of Medical Epidemiology and Biostatistics, Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This is an uncontrolled feasibility study with one arm.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 27, 2018

First Posted

April 3, 2018

Study Start

April 16, 2018

Primary Completion

December 20, 2018

Study Completion

April 25, 2019

Last Updated

December 11, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations