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Идёт набор NCT04793828

A Transdiagnostic, Self-guided Internet Intervention ("Velibra") for Waitlist Patients With Anxiety Disorders

Без фазы С лечением Panic Disorder With Agoraphobia Panic Disorder Without Agoraphobia Generalized Anxiety Disorder Social Anxiety 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: Velibra.
Кому может быть актуально
Состояния в реестре: Panic Disorder With Agoraphobia, Panic Disorder Without Agoraphobia, Generalized Anxiety Disorder, Social Anxiety Disorder. Базовые параметры: 18 лет — 65 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
Германия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

The Effect of a Transdiagnostic, Self-guided Internet Intervention ("Velibra") for Waitlist Patients With Anxiety Disorders

Обзор

The project's aim is to investigate the effect of a transdiagnostic, self-guided, internet-based cognitive behavioral therapy program in waitlist patients with anxiety disorders.

Подробное описание

Patients who fulfill the inclusion criteria and are interested in psychotherapy are offered participation in the study to bridge the waiting time for face-to-face psychotherapy. After obtaining informed consent, a pre-treatment assessment is conducted. Then, participants are provided access to velibra, an internet-based cognitive behavioral therapy program which they can work through at their own pace. While velibra is a self-guided program, participants are supported by study personnel during four assessments at four time points: pre-treatment, mid-treatment (after the first three velibra modules), post-treatment and at the one-month follow-up. The investigators expect improvements on the primary as well as the secondary outcomes. Furthermore, the investigators are interested in studying the acceptability of velibra and whether positive changes already become observable after the first three modules, i.e., at the mid-treatment assessment.

Вмешательства

  • Поведенческое Velibra
    Velibra is an internet-based cognitive behavioral therapy program developed by GAIA AG. It consists of six modules which are meant to be completed over a span of 6 weeks. The first module educates participants about anxiety and the treatment program. The second module focuses on cognitive techniques for dealing with anxiety. In the third module, relaxation techniques are practiced. The fourth module encourages the participant to practice non-anxious behaviors. In the fifth module, the central to

Первичные конечные точки

  • Panic and Agoraphobia Scale (PAS) [Срок оценки: Baseline (pre-treatment)]
  • Panic and Agoraphobia Scale (PAS) [Срок оценки: During the intervention (mid-treatment)]
  • Panic and Agoraphobia Scale (PAS) [Срок оценки: Immediately after / as soon as possible after the intervention (post-treatment)]
  • Panic and Agoraphobia Scale (PAS) [Срок оценки: 1-month follow-up]
  • Liebowitz Social Anxiety Scale (LSAS) [Срок оценки: Baseline (pre-treatment)]
  • Liebowitz Social Anxiety Scale (LSAS) [Срок оценки: During the intervention (mid-treatment)]
  • Liebowitz Social Anxiety Scale (LSAS) [Срок оценки: Immediately after / as soon as possible after the intervention (post-treatment)]
  • Liebowitz Social Anxiety Scale (LSAS) [Срок оценки: 1-month follow-up]
  • Penn State Worry Questionnaire (PSWQ) [Срок оценки: Baseline (pre-treatment)]
  • Penn State Worry Questionnaire (PSWQ) [Срок оценки: During the intervention (mid-treatment)]
Вторичные конечные точки (12)
  • Beck Anxiety Inventory (BAI) [Срок оценки: Baseline (pre-treatment)]
  • Beck Anxiety Inventory (BAI) [Срок оценки: During the intervention (mid-treatment)]
  • Beck Anxiety Inventory (BAI) [Срок оценки: Immediately after / as soon as possible after the intervention (post-treatment)]
  • Beck Anxiety Inventory (BAI) [Срок оценки: 1-month follow-up]
  • Beck Depression Inventory-II (BDI-II) [Срок оценки: Baseline (pre-treatment)]
  • Beck Depression Inventory-II (BDI-II) [Срок оценки: During the intervention (mid-treatment)]
  • Beck Depression Inventory-II (BDI-II) [Срок оценки: Immediately after / as soon as possible after the intervention (post-treatment)]
  • Beck Depression Inventory-II (BDI-II) [Срок оценки: 1-month follow-up]
  • Anxiety Sensitivity Index (ASI) [Срок оценки: Baseline (pre-treatment)]
  • Anxiety Sensitivity Index (ASI) [Срок оценки: During the intervention (mid-treatment)]
  • Anxiety Sensitivity Index (ASI) [Срок оценки: Immediately after / as soon as possible after the intervention (post-treatment)]
  • Anxiety Sensitivity Index (ASI) [Срок оценки: 1-month follow-up]

Критерии участия

Критерии включения

  • Diagnosis of panic disorder with or without agoraphobia, social anxiety disorder, or generalized anxiety disorder
  • Knowledge of German that is sufficient for engaging with the treatment and responding to the questionnaires
  • Written informed consent
  • Internet access

Критерии исключения

  • Diagnoses of severe mental comorbidities (e.g., schizophrenia, severe major depression, borderline personality disorder)
  • Acute suicidality
  • Started or changed anxiolytic pharmacotherapy recently (currently or in the past four weeks)

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

Германия · 1 центр
  • Department of Psychiatry and Psychotherapy, Charité Campus Mitte - Universitätsmedizin Ber — Berlin

Идентификаторы

NCT: NCT04793828 · EA 1/322/19

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗