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Online Cognitive Behavior Therapy for Anxiety Related to Pediatric Asthma

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06657807
Enrollment
30
Registered
2024-10-24
Start date
2024-12-01
Completion date
2026-12-01
Last updated
2026-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Asthma

Keywords

Internet-CBT, Adolescent, Children, Parents

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.

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.

Interventions

BEHAVIORALOnline CBT

Online CBT targeting anxiety in pediatric asthma

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
PedsQL Asthma ModuleFrom pretreatment to 16 weeksQuestionnarie 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).

Secondary

MeasureTime frameDescription
PedsQL Quality of Life InventoryFrom pretreatment to 16 weeksQuestionnaire 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).
Asthma Control TestFrom pretreatment to 16 weeksAsthma Severity
Asthma Behavior ChecklistFrom pretreatment to 16 weeksAvoidance behavior due to fear of asthma
Fear of Asthma Symptoms ScaleFrom pretreatment to 16 weeksFear of bodily symptoms of Asthma. Questionnaire where the scale ranges from 0 (never) to 5 (always). A higher score means worse outcome.
Youth Asthma Related Anxiety ScaleFrom pretreatment to 16 weeksAnxiety related to asthma. Questionnaire where the scale ranges from 0 (never) to 5 (always). A higher score means worse outcome.
Subjective Adequate Relief QuestionnaireWeek 8Subjective 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).
Client Satisfaction QuestionnaireWeek 8
Working Alliance InventoryWeek 3Questionnaire 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.
Credibility Rating ScaleWeek 2The 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.
Adverse eventsWeek 8
Spence Children's Anxiety ScaleFrom pretreatment to 16 weeksSpence 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.
Child Depression InventoryFrom pretreatment to 16 weeks
Adult responses to children's symptomsFrom pretreatment to 16 weeksQuestionnaire 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.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 15, 2026