Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06657807
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-03
Brief Title:
Online Cognitive Behavior Therapy for Anxiety Related to Pediatric Asthma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Online Cognitive Behavior Therapy for Anxiety Related to Pediatric Asthma a Feasibility Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 childs 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
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 childs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None