Exposure-Based CBT for Youth With Blood and Injection Phobia and Chronic Illness

Официальное название

"Confront the Fear" - Evaluation of a Novel Exposure-Based CBT for Youth With Blood and Injection Phobia and Concurrent Somatic Illness Requiring Injections

Обзор

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.

Вмешательства

• Поведенческое Exposure based CBT
  This intervention is an exposure-based CBT program developed for children with blood-injection-injury (BII) phobia and a co-occurring somatic illness. The treatment includes a structured home training kit with medical materials (e.g., syringes, swabs) related to the child's fear, enabling frequent and realistic exposure exercises at home between sessions, guided by parents. This allows for higher treatment intensity and continuity. The intervention is tailored to children who require regular med

Первичные конечные точки

• Behavior Avoidance Test (BAT) [Срок оценки: Baseline (prior to treatment session 1) and post-treatment (at treatment session 11)]
• Injection Phobia Scale (IPS) [Срок оценки: Baseline (at treatment session 1), post-treatment (at treatment session 11), and follow-up at 1 month and 3 months post-treatment]

Вторичные конечные точки (1)

• Revised Child Anxiety and Depression Scale 25 items (RCADS-25) [Срок оценки: Baseline (at treatment session 1), post-treatment (at treatment session 11), and follow-up at 1 month and 3 months post-treatment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• Significant cognitive or intellectual impairment;
• Severe psychopathology (e.g., suicidality);
• Acute trauma;
• Ongoing or recently completed treatment for BII phobia.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07125287 · 2024-08344-01 · K 2025-5350

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗