Online Cognitive Behavior Therapy for Anxiety Related to Pediatric Asthma

NCT06657807 | Recruiting

• 1 other identifier: EPM Dnr: 2023-01304-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Asthma is a chronic condition affecting approximately 5-15% of all Swedish children. Research has shown that asthma may be associated with increased anxiety and worry, with children who have asthma being twice as likely to experience anxiety compared to those without asthma. The coexistence of anxiety and asthma can worsen asthma symptoms and heighten anxiety, as it can be challenging to distinguish between the two conditions. Cognitive behavioral therapy (CBT) is a recommended treatment for anxiety in children, but few studies have examined the effectiveness of CBT in children with both asthma and anxiety. Our research group has previously developed internet-delivered CBT (Internet-CBT) targeting anxiety in asthma for adults, yielding promising results. Internet-CBT can significantly improve access to treatment and has been shown to be both effective and safe for other medical conditions. The primary aim of this project is to investigate whether Internet-CBT can contribute to improved quality of life, better asthma control, and reduced anxiety in children and adolescents whose asthma is complicated by their own or their parents' anxiety. We have previously developed Internet-CBT for adults with asthma and anxiety with promising outcomes. For this study, we have adapted the treatment for children, adolescents, and their parents and will evaluate its feasibility and clinical effectiveness.

Conditions

Asthma; Anxiety

Keywords

Internet-CBT; Adolescent; Children; Parents

Outcome Measures

Primary Outcomes (1)

• PedsQL Asthma Module

  Questionnarie about asthma symptoms. Participants report how much of a problem asthma have been for them the past month on a scale ranging from 0 (never) to 5 (almost always).

  From pretreatment to 16 weeks

Secondary Outcomes (13)

• PedsQL Quality of Life Inventory

  From pretreatment to 16 weeks

• Asthma Control Test

  From pretreatment to 16 weeks

• Asthma Behavior Checklist

  From pretreatment to 16 weeks

• Fear of Asthma Symptoms Scale

  From pretreatment to 16 weeks

• Youth Asthma Related Anxiety Scale

  From pretreatment to 16 weeks

Study Arms (1)

Internet-CBT

EXPERIMENTAL

Internet-CBT including 8 weekly modules

Behavioral: Online CBT

Interventions

Online CBT BEHAVIORAL

Online CBT targeting anxiety in pediatric asthma

Also known as: Internet-CBT, Internet-delivered cognitive behavior therapy

Internet-CBT

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 8-17 years
• A diagnosis of asthma made by a physician and confirmed by the parents
• Some anxiety related to asthma reported by either parent of child ("Do you feel stressed or worried about your asthma?" yes/no) and/or some restriction by asthma in daily life, which could indicate a pattern of avoidance behavior ("Do you feel hindered by your asthma in your daily life?" yes/no)

You may not qualify if:

• Presence of severe psychiatric disorders such as severe depression or suicidal ideation.
• Concurrent psychological treatment
• Presence of severe somatic disorder that could interfere with participation in the CBT-treatment
• Other respiratory disease than asthma
• Psychotropic medication should be stable for at least 1 month before entering the study.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Centre for Psychiatry Research, Karolinska Institutet & Stockholm Health Care

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

Asthma; Anxiety Disorders

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Mental Disorders

Central Study Contacts

Marianne Bonnert, PhD

CONTACT

+46737482864; marianne.bonnert@ki.se

Ulrika Ehrén, MSc

CONTACT

ulrika.ehren@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Uncontrolled feasibility study using pretest-posttest design with 2 mo FU as primiary endpoint.

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 24, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

SE (1)