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.
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 (MINI-KID). 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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Online CBT targeting anxiety in pediatric asthma
Centre for Psychiatry Research, Karolinska Institutet & Stockholm Health Care
Stockholm, Sweden
RECRUITINGPedsQL 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).
Time frame: From pretreatment to 16 weeks
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).
Time frame: From pretreatment to 16 weeks
Asthma Control Test
Asthma Severity
Time frame: From pretreatment to 16 weeks
Asthma Behavior Checklist
Avoidance behavior due to fear of asthma
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Week 8
Client Satisfaction Questionnaire
Time frame: 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.
Time frame: 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.
Time frame: Week 2
Adverse events
Time frame: Week 8
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.
Time frame: From pretreatment to 16 weeks
Child Depression Inventory
Time frame: 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.
Time frame: From pretreatment to 16 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.