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Internet-delivered CBT for Asthma-related Anxiety: Feasibility

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Internet-CBT for anxiety-related asthma
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Anxiety, Stress

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Department of Medical Epidemiology and Biostatistics, Karolinska Institutet

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Internet-CBT

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Penn State Worry Questionnaire
Change in subjective worry measured with a self-rating scale measured with a self-rating scale at baseline, 8 weeks, 16 weeks and 24 weeks for analysis of effect.
Asthma control test
Change in asthma control measured with a self-rating scale at baseline, 8 weeks, 16 weeks and 24 weeks for analysis of effect.
Asthma Quality of Life Questionnaire
Change in asthma-related quality of life measured with a self-rating scale at baseline, 8 weeks, 16 weeks and 24 weeks for analysis of effect.
Short Health Anxiety Inventory (SHAI)
Change in health anxiety measured with a self-rating scale at baseline, 8 weeks, 16 weeks and 24 weeks for analysis of effect.
Perceived Stress Scale
Change in perceived stress measured with a self-rating scale at baseline, 8 weeks, 16 weeks and 24 weeks for analysis of effect.

Full Information

First Posted
March 27, 2018
Last Updated
December 10, 2019
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT03486756
Brief Title
Internet-delivered CBT for Asthma-related Anxiety: Feasibility
Official Title
Internet-delivered Cognitive Behavior Therapy for Asthma-related Anxiety: A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
April 16, 2018 (Actual)
Primary Completion Date
December 20, 2018 (Actual)
Study Completion Date
April 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
Detailed Description
Asthma is one of the most common chronic diseases around the world, with a high prevalence of anxiety disorders. In a prior study (ClinicalTrials.gov ID: NCT03158194) a protocol for exposure-based CBT was developed for asthma-related anxiety. The aim of the current study is to evaluate acceptability and feasibility of our protocol for asthma-related fear when delivered over the Internet (Internet-CBT). The plan is to include 30 participants that will all receive the intervention in this uncontrolled feasibility study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Anxiety, Stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is an uncontrolled feasibility study with one arm.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Internet-CBT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Internet-CBT for anxiety-related asthma
Intervention Description
The specific assignments in the intervention will be based on individual behavior analysis for each participant.
Primary Outcome Measure Information:
Title
Catastrophizing about asthma Scale
Description
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.
Time Frame
Baseline to 8 weeks; baseline to 16 weeks; baseline to 24 weeks.
Secondary Outcome Measure Information:
Title
Penn State Worry Questionnaire
Description
Change in subjective worry measured with a self-rating scale measured with a self-rating scale at baseline, 8 weeks, 16 weeks and 24 weeks for analysis of effect.
Time Frame
Baseline to 8 weeks; baseline to 16 weeks; baseline to 24 weeks.
Title
Asthma control test
Description
Change in asthma control measured with a self-rating scale at baseline, 8 weeks, 16 weeks and 24 weeks for analysis of effect.
Time Frame
Baseline to 8 weeks; baseline to 16 weeks; baseline to 24 weeks.
Title
Asthma Quality of Life Questionnaire
Description
Change in asthma-related quality of life measured with a self-rating scale at baseline, 8 weeks, 16 weeks and 24 weeks for analysis of effect.
Time Frame
Baseline to 8 weeks; baseline to 16 weeks; baseline to 24 weeks.
Title
Short Health Anxiety Inventory (SHAI)
Description
Change in health anxiety measured with a self-rating scale at baseline, 8 weeks, 16 weeks and 24 weeks for analysis of effect.
Time Frame
Baseline to 8 weeks; baseline to 16 weeks; baseline to 24 weeks.
Title
Perceived Stress Scale
Description
Change in perceived stress measured with a self-rating scale at baseline, 8 weeks, 16 weeks and 24 weeks for analysis of effect.
Time Frame
Baseline to 8 weeks; baseline to 16 weeks; baseline to 24 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: asthma diagnosed by a physician anxiety or stress related to asthma Exclusion Criteria: severe psychiatric disorder chronic obstructive pulmonary disease (COPD) and other chronic airway disorders other than asthma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catarina Almqvist Malmros, MD PhD
Organizational Affiliation
Department of Medical Epidemiology and Biostatistics, Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medical Epidemiology and Biostatistics, Karolinska Institutet
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34401374
Citation
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.
Results Reference
derived

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Internet-delivered CBT for Asthma-related Anxiety: Feasibility

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