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Идёт набор NCT05333627

Internet-delivered Cognitive Behaviour Therapy for Students: Duration Preference Trial

Без фазы С лечением Depression Anxiety

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: Wellbeing Course for Students (Fast Track), Wellbeing Course for Students (5 weeks), Wellbeing Course (8 weeks).
Кому может быть актуально
Состояния в реестре: Depression, Anxiety. Базовые параметры: от 18 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
Канада
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

Internet-delivered Cognitive Behaviour Therapy for Post-Secondary Students: Preference Trial for Flexible, 5-Week, and 8-Week Options

Обзор

There is growing evidence for the effectiveness of internet-delivered cognitive behaviour therapy (ICBT) for post-secondary students with symptoms of depression and anxiety. In ICBT, clients review structured online content over several weeks to learn strategies and skills to manage their symptoms. Low treatment completion rates remain a concern for post-secondary students, so it is possible that existing treatment protocols do not offer enough flexibility for students' needs and preferences. This trial will examine students' preferences for different course options (fast-track, 5-week, and 8-week) and compare enrollment, adherence, and outcomes of students who pick each of the three options. In all three options, students will receive optional therapist support, in which the assigned therapist only contacts the student on weeks where the student sends the therapist a message. This trial will help inform the delivery of flexible treatment options for post-secondary students in a routine care setting.

Вмешательства

  • Поведенческое Wellbeing Course for Students (Fast Track)
    The core Fast-Track lesson includes information on managing their cycle of symptoms, motivation, and an overview of strategies that can be used to manage symptoms of depression and anxiety. After the core lesson, clients can access three additional Do-It-Yourself guides that focus on thought challenging, controlled breathing/activity planning, and behavioural activation/relapse prevention. These materials are able to be accessed out of sequence on a schedule that suits their needs. With optional
  • Поведенческое Wellbeing Course for Students (5 weeks)
    The 5-week course consists of four lessons that provide psychoeducation about: symptom identification and the cognitive behavioural model, thought monitoring and challenging, controlled breathing and pleasant activity scheduling, graded exposure, and relapse prevention. With optional therapist support, therapists will respond to any messages that clients send once per week. Therapists will not message clients on weeks where the client does not send a message.
  • Поведенческое Wellbeing Course (8 weeks)
    The 8-week course consists of five lessons that provide psychoeducation about: symptom identification and the cognitive behavioural model, thought monitoring and challenging, controlled breathing and pleasant activity scheduling, graded exposure, and relapse prevention. With optional therapist support, therapists will respond to any messages that clients send once per week. Therapists will not message clients on weeks where the client does not send a message.

Первичные конечные точки

  • Patient Health Questionnaire 9-item (PHQ-9) [Срок оценки: Baseline (screening), weeks 1-5 (Fast-Track and 5-week course), weeks 1-8 (8-week course), and week 16 (all course options)]
  • Generalized Anxiety Disorder 7-item (GAD-7) [Срок оценки: Baseline (screening), weeks 1-5 (Fast-Track and 5-week course), weeks 1-8 (8-week course), and week 16 (all course options)]
  • Perceptions of Academic Functioning (PAF) [Срок оценки: Baseline (screening), weeks 1-5 (Fast-Track and 5-week course), weeks 1-8 (8-week course), and week 16 (all course options)]
Вторичные конечные точки (3)
  • Credibility and Expectancy Questionnaire (CEQ) [Срок оценки: Baseline (screening), week 5 (Fast-Track and 5-week course), week 8 (8-week course)]
  • Treatment Satisfaction [Срок оценки: Week 5 (Fast-Track and 5-week course); Week 8 (8-week course)]
  • Work and Social Adjustment Scale (WSAS) [Срок оценки: Baseline (screening), week 5 (Fast-Track and 5-week course), week 8 (8-week course)]

Критерии участия

Критерии включения

  • registered as a student at a post-secondary institution in Saskatchewan; over the age of 18; endorse symptoms of depression (score of 5 or greater on the PHQ-9) and/or anxiety (score of 5 or greater on the GAD-7); and be able to access computers and the Internet and be comfortable using them

Критерии исключения

  • high risk of suicide or hospitalization for mental health in previous 12 months; unmanaged alcohol or drug use problems; severe psychiatric illness that is not managed (e.g. psychosis or mania); or receiving other psychological services more than twice per month

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Канада · 1 центр
  • Online Therapy Unit, University of Regina — Regina

Идентификаторы

NCT: NCT05333627 · 2019-205b

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗