Online Cognitive Behavior Therapy for Anxiety Related to Pediatric Asthma (NCT06657807) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Online Cognitive Behavior Therapy for Anxiety Related to Pediatric Asthma
Sweden30 participantsStarted 2024-12-01
Plain-language 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.
Who can participate
Age range
8 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is studying an online cognitive behavior therapy program for kids who have both asthma and anxiety — is my child's level of anxiety related to their asthma significant enough that a program like this might actually help them?
2Since this trial is listed as 'active, not recruiting,' enrollment is already closed — are there similar online CBT programs for asthma-related anxiety that my child could still access right now, either through another study or as a standard care option?
3The trial is measuring quality of life specifically related to asthma using something called the PedsQL Asthma Module — what does that tool actually measure, and how would we know if my child's asthma-related quality of life is currently being affected in a way this kind of therapy targets?
4This trial doesn't list a traditional drug or device phase, which suggests it's focused on a behavioral approach — before trying something like online CBT, should we first make sure my child's asthma itself is as well-controlled as possible with their current medications?
5Are there any risks or downsides to a child doing cognitive behavior therapy focused on asthma anxiety, and could it ever make a child more anxious about their condition rather than less?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.