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Cognitive Behavior Therapy for Anxiety-related Asthma in Adults.

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
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 Anxiety, Stress, Asthma

Eligibility Criteria

18 Years - undefined (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 (e.g. psychotic disorder, addiction disorder, suicidal ideation).

Sites / Locations

  • Department of Medical Epidemiology and Biostatistics, Karolinska Institutet

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CBT for anxiety-related asthma

Arm Description

Ten to twelve weekly sessions of CBT targeting enhanced function and decreased symptoms of anxiety.

Outcomes

Primary Outcome Measures

Penn State Worry Questionnaire
Change in subjective worry measured with a self-rating scale weekly during 1-3 weeks at baseline and at 10 to 12 weeks post treatment for analysis of effect.

Secondary Outcome Measures

Anxiety Sensitivity Index-3
Change in anxiety sensitivity measured with a self-rating scale weekly during 1-3 weeks at baseline and at 10 to 12 weeks post treatment for analysis of effect.
Short Health Anxiety Inventory (SHAI)
Change in health anxiety measured with a self-rating scale weekly during 1-3 weeks at baseline and at 10 to 12 weeks post treatment for analysis of effect.
Asthma Quality of Life Questionnaire
Change in asthma-related quality of life measured with a self-rating scale at pretreatment and at 10 to 12 weeks post treatment for analysis of effect.
Asthma control test
Change in asthma control measured with a self-rating scale daily during weekly 1-3 weeks at baseline and at 10 to 12 weeks post treatment for analysis of effect.
Catastrophizing about asthma Scale
Change in catastrophizing cognitions about asthma measured with a self-rating scale weekly during 1-3 weeks at baseline and at 10 to 12 weeks post treatment for analysis of effect.
Perceived Stress Scale
Change in perceived stress measured with a self-rating scale weekly 1-3 weeks at baseline and at 10 to 12 weeks post treatment for analysis of effect.
Patient Health Questionnaire
Change in depression measured with a self-rating scale at baseline and at 10 to 12 weeks post treatment for analysis of effect.

Full Information

First Posted
May 16, 2017
Last Updated
March 7, 2018
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT03158194
Brief Title
Cognitive Behavior Therapy for Anxiety-related Asthma in Adults.
Official Title
Cognitive Behavior Therapy for Anxiety-related Asthma in Adults.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
August 16, 2017 (Actual)
Primary Completion Date
March 7, 2018 (Actual)
Study Completion Date
March 7, 2018 (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 develop a protocol on Cognitive behavior therapy (CBT) for asthma-related anxiety that in a consecutive study can be translated to internet-delivered CBT.
Detailed Description
Asthma is one of the most common chronic diseases around the world, with a high prevalence of anxiety disorders. Cognitive behaviour therapy (CBT) has been shown to increase psychological well-being for anxiety-related asthma. Our primary aim is to develop a standardized CBT protocol for asthma-related anxiety that can be transferred to internet-delivered CBT. Ten participants will be included in a single-subject multiple baseline design. They will all receive 10-12 sessions of CBT.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-subject multiple baseline design.
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT for anxiety-related asthma
Arm Type
Experimental
Arm Description
Ten to twelve weekly sessions of CBT targeting enhanced function and decreased symptoms of anxiety.
Intervention Type
Behavioral
Intervention Name(s)
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
Penn State Worry Questionnaire
Description
Change in subjective worry measured with a self-rating scale weekly during 1-3 weeks at baseline and at 10 to 12 weeks post treatment for analysis of effect.
Time Frame
Baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Anxiety Sensitivity Index-3
Description
Change in anxiety sensitivity measured with a self-rating scale weekly during 1-3 weeks at baseline and at 10 to 12 weeks post treatment for analysis of effect.
Time Frame
Baseline to 12 weeks
Title
Short Health Anxiety Inventory (SHAI)
Description
Change in health anxiety measured with a self-rating scale weekly during 1-3 weeks at baseline and at 10 to 12 weeks post treatment for analysis of effect.
Time Frame
Baseline to 12 weeks
Title
Asthma Quality of Life Questionnaire
Description
Change in asthma-related quality of life measured with a self-rating scale at pretreatment and at 10 to 12 weeks post treatment for analysis of effect.
Time Frame
Baseline to 12 weeks
Title
Asthma control test
Description
Change in asthma control measured with a self-rating scale daily during weekly 1-3 weeks at baseline and at 10 to 12 weeks post treatment for analysis of effect.
Time Frame
Baseline to 12 weeks
Title
Catastrophizing about asthma Scale
Description
Change in catastrophizing cognitions about asthma measured with a self-rating scale weekly during 1-3 weeks at baseline and at 10 to 12 weeks post treatment for analysis of effect.
Time Frame
Baseline to 12 weeks
Title
Perceived Stress Scale
Description
Change in perceived stress measured with a self-rating scale weekly 1-3 weeks at baseline and at 10 to 12 weeks post treatment for analysis of effect.
Time Frame
Baseline to 12 weeks
Title
Patient Health Questionnaire
Description
Change in depression measured with a self-rating scale at baseline and at 10 to 12 weeks post treatment for analysis of effect.
Time Frame
Baseline to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 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 (e.g. psychotic disorder, addiction disorder, suicidal ideation).
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

Learn more about this trial

Cognitive Behavior Therapy for Anxiety-related Asthma in Adults.

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