Cognitive Behavior Therapy for Anxiety-related Asthma in Adults.

Asthma Clinical Trial

Official title:

Cognitive Behavior Therapy for Anxiety-related Asthma in Adults.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03158194
• Other study ID #: MANTRA 01
• Status: Completed
• Phase: N/A
• First received: May 16, 2017
• Last updated: March 7, 2018
• Start date: August 16, 2017
• Est. completion date: March 7, 2018

Study information

• Verified date: March 2018
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: March 7, 2018
• Est. primary completion date: March 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• CBT for anxiety-related asthma
The specific assignments in the intervention will be based on individual behavior analysis for each participant.

Locations

Country	Name	City	State
Sweden	Department of Medical Epidemiology and Biostatistics, Karolinska Institutet	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to 12 weeks
Secondary	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.	Baseline to 12 weeks
Secondary	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.	Baseline to 12 weeks
Secondary	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.	Baseline to 12 weeks
Secondary	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.	Baseline to 12 weeks
Secondary	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.	Baseline to 12 weeks
Secondary	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.	Baseline to 12 weeks
Secondary	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.	Baseline to 12 weeks