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Идёт набор NCT06724666

Transdiagnostic Internet-delivered Intervention for Adolescents With Anxiety and Depression

Без фазы С лечением Anxiety Disorders Depressive Disorder Social Anxiety Disorder Major Depressive Disorder

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: Transdiagnostic Internet-delivered intervention.
Кому может быть актуально
Состояния в реестре: Anxiety Disorders, Depressive Disorder, Social Anxiety Disorder, Major Depressive Disorder. Базовые параметры: 13 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
Румыния
Следующий шаг
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Обзор

The goal of this clinical trial is to test the efficacy of a transdiagnostic Internet-delivered interventions for Romanian adolescents with anxiety and/ or depression. The main questions it aims to answer are: * What is the clinical efficacy of the Internet-delivered intervention? * How accurate is the prediction model in predicting who will respond to treatment? Participants will undergo non-invasive fMRI to measure variability in brain signal as a proxy of the neural systems' adaptability before receiving the intervention, then they will be allocated either to the Internet-delivered intervention or control group.

Подробное описание

To the best of investigators' knowledge, this is the first clinical trial conducted with adolescents diagnosed with anxiety/and or depressive disorders that tests the accuracy of a prediction model based on fMRI to investigate participants' response to a transdiagnostic Internet-delivered intervention.

Вмешательства

  • Поведенческое Transdiagnostic Internet-delivered intervention
    The intervention consists of 8 modules based on Rational emotive therapy, delivered via 8 weeks.

Первичные конечные точки

  • Internalizing problems [Срок оценки: baseline, after 8 weeks of intervention, 6 months follow-up]
Вторичные конечные точки (12)
  • Clinical diagnosis [Срок оценки: administered pre-baseline, post-baseline (after 8 week waitlist period), after 8 weeks of intervention]
  • Global functioning [Срок оценки: baseline, after 8 weeks of intervention, 6 months follow-up]
  • Severity [Срок оценки: baseline, after 8 weeks of intervention, 6 months follow-up]
  • Improvement [Срок оценки: after 8 weeks of intervention, 6 months follow-up]
  • Comorbid problems [Срок оценки: baseline, after 8 weeks of intervention, 6 month follow-up]
  • Life satisfaction [Срок оценки: baseline, after 8 weeks of intervention, 6 months follow-up]
  • Satisfaction with the Internet-delivered intervention [Срок оценки: after 8 weeks of intervention]
  • Working alliance [Срок оценки: after 8 weeks of intervention]
  • Automatic thoughts [Срок оценки: baseline, after 8 weeks of intervention, 6 month follow-up]
  • Credibility and expectations [Срок оценки: week 2]
  • Credibility and expectations based on primary outcome measure [Срок оценки: baseline]
  • Anxiety and depressive symptoms [Срок оценки: baseline, at each 2 weeks during treatment duration, after 8 weeks of intervention, 6 months follow-up]

Критерии участия

Критерии включения

  • elevated symptoms of anxiety or depression/ internalizing problems (T score> 60) at intake (based on Youth self-report completed by adolescents)
  • primary diagnosis of an anxiety/depressive disorder based on DSM-5 criteria according to ADIS-5-C/P interview
  • age 13-17
  • able to read and understand Romanian language
  • Currently unmedicated or on stable and adequate doses of medication for at least 6 weeks before treatment onset
  • Internet access

Критерии исключения

  • severe mental disorder (psychosis, severe depression, bipolar disorder, based on clinical interview)
  • any condition that interferes with the protocol implementation (e.g., physical illness or sensory impairment that interferes with behavioral tasks such as exposure, behavioral activation, unavailable for the next 3 months),
  • active suicidal ideation (assessed by child psychiatrist during clinical interview) in the last month
  • currently following CBT/ psychotherapy for anxiety/depression, in the last 6 months
  • fMRI incompatible (based on safety questionnaire)
  • Being diagnosed with an intellectual disability, pervasive developmental disorder, an alcohol and/or substance dependence disorder, reading disabilities (based on clinical interview).
  • Current treatment with benzodiazepines

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Румыния · 2 центра
  • Babes-Bolyai University — Cluj-Napoca
  • Babeș-Bolyai University — Cluj-Napoca

Идентификаторы

NCT: NCT06724666 · PNRR-III-C9-2022-I8-CF278

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗