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Идёт набор NCT05945251

ICBT for Children With FAPDs - the Child's Pain Regulation

— Наблюдательное Functional Abdominal Pain Syndrome

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Internet-delivered cognitive behavioral therapy.
Кому может быть актуально
Состояния в реестре: Functional Abdominal Pain Syndrome. Базовые параметры: 8 лет — 17 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Швеция
Следующий шаг
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Официальное название

Individualized Online Cognitive Behavioral Therapy for Children With Functional Abdominal Pain Disorders - the Child's Pain Regulation

Обзор

Functional abdominal pain disorders (FAPDs) in children are common (14%) and abdominal pain has increased rapidly in children during the last ten years in Sweden. Many children with FAPDs have low quality of life, missed school days, and about 30-40% suffer from psychiatric comorbidity. FAPDs are often sustained into adulthood and a large Swedish cohort study showed that abdominal pain during childhood is an independent strong predictor anxiety and depression later in life. Internet-cognitive behavioral therapy (Internet-CBT) can improve FAPD symptoms, but a significant number of children does not respond to the treatment. We will here determine the pain regulation in children with FAPDs, compared with healthy controls, and assess: What aspects of the child's pain regulation is related to improvement for children with FAPDs engaging in Internet-CBT? Does some aspects of the child's pain regulation change during treatment?

Вмешательства

  • Другое Internet-delivered cognitive behavioral therapy
    Ten weekly modules for children and ten weekly modules for parents. Exposure-based cognitive behavioral therapy delivered online with asynchronous support via text messages from psychologists.

Первичные конечные точки

  • Pressure pain threshold on navel [Срок оценки: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)]
  • Unpleasantness of pressure pain threshold on navel [Срок оценки: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)]
Вторичные конечные точки (11)
  • Pressure pain threshold on thigh [Срок оценки: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)]
  • Unpleasantness of pressure pain threshold on thigh [Срок оценки: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)]
  • Conditioned pain modulation [Срок оценки: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)]
  • Temporal summation [Срок оценки: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)]
  • Sensory attenuation of pain [Срок оценки: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)]
  • Resting state fMRI [Срок оценки: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)]
  • fMRI during low pain compared with non-painful tactile stimulus [Срок оценки: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)]
  • Pediatric Quality of Life Inventory Gastrointestinal Symptom Scale (PedsQL Gastro) [Срок оценки: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)]
  • Faces Pain Rating Scale (FACES) [Срок оценки: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)]
  • Visceral sensitivity Index, child-adapted short version (VSI-C) [Срок оценки: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)]
  • Irritable bowel syndrome-behavioral responses questionnaire, child-adapted short version (BRQ-C) [Срок оценки: Baseline differences and baseline to follow-up after 10 week's treatment (or 10 week's wait for healthy children)]

Критерии участия

Критерии включения

Children 8-17 years with FAPDs: Have been offered treatment at BUP Internetbehandling for FAPDs.

Children 8-17 years without FAPDs: Not affected by recurrent (every week) or persistant pain during the last year.

Критерии исключения

Contraindication for MR (metal implant or metal object in body, claustrophobia, pregnancy)

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Швеция · 1 центр
  • Karolinska Institutet — Stockholm

Идентификаторы

NCT: NCT05945251 · 20223238

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗