NCT03158194

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started Aug 2017

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

May 16, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 18, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

August 16, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2018

Completed
Last Updated

March 8, 2018

Status Verified

March 1, 2018

Enrollment Period

7 months

First QC Date

May 16, 2017

Last Update Submit

March 7, 2018

Conditions

Asthma

Keywords

AnxietyStressAsthma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Anxiety Sensitivity Index-3

    Baseline to 12 weeks

  • Short Health Anxiety Inventory (SHAI)

    Baseline to 12 weeks

  • Asthma Quality of Life Questionnaire

    Baseline to 12 weeks

  • Asthma control test

    Baseline to 12 weeks

  • Catastrophizing about asthma Scale

    Baseline to 12 weeks

  • +2 more secondary outcomes

Study Arms (1)

CBT for anxiety-related asthma

EXPERIMENTAL

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

Behavioral: CBT for anxiety-related asthma

Interventions

CBT for anxiety-related asthmaBEHAVIORAL

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

CBT for anxiety-related asthma

Eligibility Criteria

Age18 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 (e.g. psychotic disorder, addiction disorder, suicidal ideation).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medical Epidemiology and Biostatistics, Karolinska Institutet

Stockholm, Sweden

Location

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: Single-subject multiple baseline design.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 16, 2017

First Posted

May 18, 2017

Study Start

August 16, 2017

Primary Completion

March 7, 2018

Study Completion

March 7, 2018

Last Updated

March 8, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)