Online Cognitive Behavior Therapy for Anxiety Related to Pediatric Asthma

Online Cognitive Behavior Therapy for Anxiety Related to Pediatric Asthma: A Feasibility Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Asthma; Anxiety
• Intervention / Treatment: Behavioral: Online CBT

Detailed Description

This study will use an uncontrolled pretest-posttest design, all participants will receive the intervention. The intervention consists of 8 weekly modules delivered over internet with guided support from an experienced CBT-trained psychologist.

Assessments will be made pretreatment, weekly during treatment for the primary outcome and potential mediators, posttreatment, at the primary endpoint 2 months after treatment completion and at follow up 6 months after treatment completion. Thirty participants (aged 8-17 years) will be included. All outcome data will be collected digitally and include for feasibility: treatment credibility, working alliance, compliance with the treatment (number of modules completed) and with asthma medications as prescribed by the child´s physician, any adverse events, subjective overall relief and satisfaction with treatment. For potential efficacy, the clinical effect in the group will be analyzed on pre- to post-measurements, including weekly measurements and 2 months follow up after treatment termination (primary endpoint). The participants will be followed 6 months after treatment completion to analyze longer term clinical effects.

Recruitment and inclusion procedure Participants will be self-recruited through advertisements in social media and posters at pediatric health care clinics. Potential participants will undergo an online self-report screening of eligible criteria. The parents and adolescents 15 and older, will receive digital information about the study and leave their written consent online. The screening will be followed by an evaluation with a clinical psychologist using a structured interview based on the DSM diagnostic. During the clinical interview, the children (>age 15) will receive information about the study and leave their informed consent orally. The families will have the opportunity to ask questions about the study and confirm previous written consent.

After inclusion, participants may start their treatment immediately.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Centre for Psychiatry Research, Karolinska Institutet & Stockholm Health Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Internet-CBT; Internet-CBT including 8 weekly modules	Behavioral: Online CBT; Online CBT targeting anxiety in pediatric asthma; Other Names: Internet-CBT; Internet-delivered cognitive behavior therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events		Week 8
PedsQL Quality of Life Inventory	Questionnaire about Quality of Life. Participants report how much of a problem they/their child has with psychical, emotional, social and study functioning for them the past month on a scale ranging from 0 (never) to 5 (almost always).	From pretreatment to 16 weeks
Asthma Control Test	Asthma Severity	From pretreatment to 16 weeks
Asthma Behavior Checklist	Avoidance behavior due to fear of asthma	From pretreatment to 16 weeks
Fear of Asthma Symptoms Scale	Fear of bodily symptoms of Asthma. Questionnaire where the scale ranges from 0 (never) to 5 (always). A higher score means worse outcome.	From pretreatment to 16 weeks
Youth Asthma Related Anxiety Scale	Anxiety related to asthma. Questionnaire where the scale ranges from 0 (never) to 5 (always). A higher score means worse outcome.	From pretreatment to 16 weeks
Subjective Adequate Relief Questionnaire	Subjective Adequate Relief Questionnaire measures self-perceived change in symptoms as a result of the treatment. The scale consists of 2 items rated from 0 (much worse) to 6 (much better).	Week 8
Client Satisfaction Questionnaire		Week 8
Working Alliance Inventory	Questionnaire used to assess perceived alliance with the online therapist. The questions are scored on a scale from 1 (never) to 7 (always). A higher score means better outcome.	Week 3
Credibility Rating Scale	The Credibility Scale was developed to assess the participant's expectations of the treatment. The scale ranges from 0 (not at all) to 10 (very much). A higher score means better outcome.	Week 2
Spence Children's Anxiety Scale	Spence Children's Anxiety Scale is used to assess symptoms of anxiety and is specifically developed for children. The scale ranges from never (0) to always (3). A higher score means worse outcome.	From pretreatment to 16 weeks
Child Depression Inventory		From pretreatment to 16 weeks
Adult responses to children's symptoms	Questionnaire used to assess how parents respond to their children when they have symptoms. The questions are scored on a scale from 0 (never) to 4 (always). A higher score means worse outcome.	From pretreatment to 16 weeks

Collaborators and Investigators

• Sponsor: Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: October 3, 2024
• First Submitted That Met QC Criteria: October 23, 2024
• First Posted (Actual): October 24, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Adolescent; Children; Parents; Internet-CBT
• Additional Relevant MeSH Terms: Mental Disorders; Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma; Anxiety Disorders
• Other Study ID Numbers: EPM Dnr: 2023-01304-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No