"Confront the Fear" - Evaluation of a Novel Exposure-Based CBT for Youth With Blood and Injection Phobia and Concurrent Somatic Illness Requiring Injections
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Injection Phobia Scale (IPS)
研究概览
简要总结
More than half of all children fear needles, and hospitalized children often describe injections as the most frightening part of medical care. While mild needle fear can often be managed by healthcare staff using distraction and reassurance, these strategies are ineffective for children with blood-injection-injury phobia (BII phobia). Children with BII phobia and co-occurring chronic medical conditions often require repeated blood tests or injections, but their phobia may prevent essential treatment. In such cases, healthcare providers may be forced to use physical restraint, sedation, or general anesthesia-approaches that are distressing for the child and costly for the healthcare system.
Although exposure-based cognitive behavioral therapy (CBT) is an effective treatment for specific phobias in adults, there is very limited research on CBT for children with BII phobia, particularly those with serious medical conditions. At the Department of Behavioral Medicine at Karolinska University Hospital, we have developed an exposure-based CBT intervention tailored for children with BII phobia and co-occurring somatic illness. The program includes a home-based training kit with medical materials to support frequent and realistic exposure between clinic sessions. Clinical experience suggests the intervention improves fear responses and increases medical treatment adherence, but it has not yet been formally evaluated.
This study aims to evaluate the feasibility and effectiveness of this novel CBT intervention for children and adolescents with disabling BII phobia and chronic somatic conditions.
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
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12-17 years;
- •Blood-Injection-Injury (BII) phobia;
- •Somatic disease or condition requiring regular injections and/or blood sampling;
- •Ability to read and write in Swedish.
排除标准
- •Significant cognitive or intellectual impairment;
- •Severe psychopathology (e.g., suicidality);
- •Acute trauma;
- •Ongoing or recently completed treatment for BII phobia.
研究组 & 干预措施
Treatment group
Exposure based CBT
干预措施: Exposure based CBT (Behavioral)
结局指标
主要结局
Injection Phobia Scale (IPS)
时间窗: Baseline (at treatment session 1), post-treatment (at treatment session 11), and follow-up at 1 month and 3 months post-treatment
A child-adapted version of the Injection Phobia Scale (Öst, Hellström \& Kåver, 1992). In this study, only the subscale measuring anxiety level is used. The original subscale has demonstrated high internal consistency, with a Cronbach's alpha of 0.86. The scale consists of 18 items, each rated on a five-point scale where the respondent indicates the amount of fear they would experience in different situations.
Behavior Avoidance Test (BAT)
时间窗: Baseline (prior to treatment session 1) and post-treatment (at treatment session 11)
An observational assessment in which the patient is asked to approach a feared situation or stimulus as far as they can, based on a predefined hierarchy of difficulty or anxiety levels. The BAT is commonly used to assess the degree of avoidance and fear in relation to specific phobia-related stimuli, and to evaluate treatment progress and outcomes. In this study, the BAT will be used to measure behavioral avoidance.
Injection Phobia Scale (IPS)
时间窗: Baseline (at treatment session 1), post-treatment (at treatment session 11), and follow-up at 1 month and 3 months post-treatment
A child-adapted version of the Injection Phobia Scale (Öst, Hellström \& Kåver, 1992). In this study, only the subscale measuring anxiety level is used. The original subscale has demonstrated high internal consistency, with a Cronbach's alpha of 0.86. The scale consists of 18 items, each rated on a five-point scale where the respondent indicates the amount of fear they would experience in different situations.
次要结局
- Revised Child Anxiety and Depression Scale 25 items (RCADS-25)(Baseline (at treatment session 1), post-treatment (at treatment session 11), and follow-up at 1 month and 3 months post-treatment)
- Revised Child Anxiety and Depression Scale 25 items (RCADS-25)(Baseline (at treatment session 1), post-treatment (at treatment session 11), and follow-up at 1 month and 3 months post-treatment)
研究者
Charlotte S Gentili
Lic Psychologist, PhD
Region Stockholm