Cognitive Behavior Therapy for Anxiety-related Asthma in Adults.

March 7, 2018 updated by: Catarina Almqvist Malmros, Karolinska Institutet
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • 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 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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CBT for anxiety-related asthma
Ten to twelve weekly sessions of CBT targeting enhanced function and decreased symptoms of anxiety.
Behavioral: CBT for anxiety-related asthma
The specific assignments in the intervention will be based on individual behavior analysis for each participant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Penn State Worry Questionnaire
Time Frame: Baseline to 12 weeks
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.
Baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety Sensitivity Index-3
Time Frame: Baseline to 12 weeks
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.
Baseline to 12 weeks
Short Health Anxiety Inventory (SHAI)
Time Frame: Baseline to 12 weeks
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.
Baseline to 12 weeks
Asthma Quality of Life Questionnaire
Time Frame: Baseline to 12 weeks
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.
Baseline to 12 weeks
Asthma control test
Time Frame: Baseline to 12 weeks
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.
Baseline to 12 weeks
Catastrophizing about asthma Scale
Time Frame: Baseline to 12 weeks
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.
Baseline to 12 weeks
Perceived Stress Scale
Time Frame: Baseline to 12 weeks
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.
Baseline to 12 weeks
Patient Health Questionnaire
Time Frame: Baseline to 12 weeks
Change in depression measured with a self-rating scale at baseline and at 10 to 12 weeks post treatment for analysis of effect.
Baseline to 12 weeks

Collaborators and Investigators

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

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: Catarina Almqvist Malmros, MD, PhD, Department of Medical Epidemiology and Biostatistics, 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)

August 16, 2017

Primary Completion (Actual)

March 7, 2018

Study Completion (Actual)

March 7, 2018

Study Registration Dates

First Submitted

May 16, 2017

First Submitted That Met QC Criteria

May 16, 2017

First Posted (Actual)

May 18, 2017

Study Record Updates

Last Update Posted (Actual)

March 8, 2018

Last Update Submitted That Met QC Criteria

March 7, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MANTRA 01

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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