Online Cognitive Behavior Therapy for Anxiety Related to Pediatric Asthma: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- PedsQL Asthma Module
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
Internet-CBT
Internet-CBT including 8 weekly modules
干预措施: Online CBT (Behavioral)
结局指标
主要结局
PedsQL Asthma Module
时间窗: From pretreatment to 16 weeks
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).
次要结局
- Adverse events(Week 8)
- PedsQL Quality of Life Inventory(From pretreatment to 16 weeks)
- Asthma Control Test(From pretreatment to 16 weeks)
- Asthma Behavior Checklist(From pretreatment to 16 weeks)
- Fear of Asthma Symptoms Scale(From pretreatment to 16 weeks)
- Youth Asthma Related Anxiety Scale(From pretreatment to 16 weeks)
- Subjective Adequate Relief Questionnaire(Week 8)
- Client Satisfaction Questionnaire(Week 8)
- Working Alliance Inventory(Week 3)
- Credibility Rating Scale(Week 2)
- Spence Children's Anxiety Scale(From pretreatment to 16 weeks)
- Child Depression Inventory(From pretreatment to 16 weeks)
- Adult responses to children's symptoms(From pretreatment to 16 weeks)
研究者
Marianne Bonnert
Principal Investigator
Karolinska Institutet