Clinical trial NCT04230369: Internet-delivered CBT for Anxiety Related to Asthma
Official title: Internet-delivered Cognitive Behaviour Therapy for Anxiety Related to Asthma: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Asthma
Anxiety
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The participants will be randomised to immediate internet-CBT or 4 months of treatment as usual before cross-over to internet-CBT.
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled trial to investigate efficacy of a internet-delivered CBT for anxiety related to asthma.

Detailed description: Asthma is one of the most common chronic diseases and is often associated with anxiety. In a two prior studies (ClinicalTrials.gov ID: NCT03158194; NCT03486756) a protocol for exposure-based cognitive behaviour therapy (CBT) for anxiety related to asthma was developed, and standardised to an internet-delivered format and tested for feasibility and acceptability as an internet-CBT. The aim of the current study is to evaluate the efficacy of exposure-based Internet-CBT for anxiety related to asthma compared to Treatment as Usual (TAU). The plan is to include 90 participants consecutively during 2020.

Eligibility criteria: Inclusion Criteria:

* asthma diagnosed by a physician
* worry about asthma or limitations in daily life due to asthma at

Exclusion Criteria:

* a serious psychiatric condition; e.g., suicidality, psychosis or severe substance addiction
* chronic obstructive pulmonary disease (COPD) or other chronic airway disorders other than asthma

Primary outcomes:
measure: Catastrophizing about asthma Scale
timeFrame: Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
Secondary outcomes:
measure: Asthma control test
timeFrame: Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
measure: Penn State Worry Questionnaire
timeFrame: Time Frame: Baseline to 8 weeks; baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
measure: Asthma Quality of Life Questionnaire
timeFrame: Time Frame: Baseline to 8 weeks; baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
measure: Short Health Anxiety Inventory (SHAI)
timeFrame: Time Frame: Baseline to 8 weeks; baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
measure: Perceived Stress Scale
timeFrame: Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
measure: Fear of Asthma Symptoms
timeFrame: Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
measure: Asthma Behaviour Checklist
timeFrame: Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
measure: Insomnia Severity Index
timeFrame: Time Frame: Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
measure: Patient Health Questionnaire-9
timeFrame: Time Frame: Baseline to 8 weeks; baseline to16 weeks; baseline to 36 weeks; baseline to 12 months.
measure: WHODAS
timeFrame: Time Frame: Baseline to 8 weeks; Baseline to 16 weeks; baseline to 36 weeks; baseline to 12 months.
measure: Brunnsviken quality of life scale
timeFrame: Time Frame: Baseline to 8 weeks; baseline to16 weeks; baseline to 36 weeks; baseline to 12 months.
measure: Treatment Inventory of Costs in Patients
timeFrame: Time Frame: Baseline to 8 weeks; baseline to16 weeks; baseline to 36 weeks; baseline to 12 months.
measure: Asthma Tuner
timeFrame: Time Frame: Baseline to 8 weeks; baseline to16 weeks.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Department of Medical Epidemiology and Biostatistics, Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Catarina A Almqvist, PhD
role: PRINCIPAL_INVESTIGATOR
References: