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Идёт набор NCT07088939

Feasibility and Acceptability of an E-learning Dialectical Behavior Therapy Skills Course

Без фазы С лечением Depression - Major Depressive Disorder Anxiety Depression Stress

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: dialectical behavior therapy.
Кому может быть актуально
Состояния в реестре: Depression - Major Depressive Disorder, Anxiety, Depression, Stress. 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

Feasibility and Acceptability of a Self-guided Internet-delivered Dialectical Behavior Therapy Intervention for Adults With Mental Health Challenges

Обзор

Dialectical behavior therapy (DBT) is a comprehensive, third-wave psychological intervention designed for patients with complex and severe behavioral, emotional, and interpersonal dysfunction. DBT has since been adapted to shorter, briefer, "skills training" formats, which have been effective for a number of mild-to-moderate mental health conditions, including depression and anxiety. Moreover, internet-delivered formats of DBT (iDBT) have similarly started to build support for their effectiveness, although there are fewer studies on digital formats. One study found that over 12 weeks, iDBT was deemed acceptable (e.g., 50% of participants were still active after 4 weeks) and there were improvements in multiple symptom domains, such as depression, anxiety, suicidality, functional disability, as well as alcohol and substance dependence. In the current study, the investigators will examine the feasibility, acceptability, and potential efficacy of a new iDBT intervention, packaged as an online e-learning skills course, with adult participants. The study is a pilot trial as iDBT has never been tested in this format through formal research. Thus, this pilot study aims to examine whether this course is usable, practical, and potentially useful to others in the future. The investigators will recruit up to 40 individuals with mild-to-moderate depression and anxiety for an 8-week study. Following a phone screen to determine eligibility, participants will complete a baseline session where they will provide consent, complete a brief interview and questionnaires, and register for the e-learning skills course. Over the course of 8 weeks, participants will be exposed to material adapted from a DBT manual in a self-guided manner. Participants will complete follow-up assessments at 4 and 8 weeks.

Вмешательства

  • Поведенческое dialectical behavior therapy
    This internet-delivered dialectical behavior therapy (iDBT) intervention consists of an e-learning course with 4 modules based on the 4 areas of skills training in dialectical behavior therapy: mindfulness, emotion regulation, distress tolerance, and interpersonal effectiveness. Participants can work through the modules at a self-guided pace to learn more than 30 specific skills using psychoeducational materials. The intervention incorporates psychoeducational elements of skills training with in

Первичные конечные точки

  • Treatment Acceptability and Adherence Scale [Срок оценки: 4 weeks and 8 weeks]
  • Intervention Usability Scale [Срок оценки: 4 weeks and 8 weeks]
Вторичные конечные точки (5)
  • Credibility and Expectancy Questionnaire [Срок оценки: Baseline]
  • Patient Health Questionnaire Depression Subscale [Срок оценки: Baseline, 4 weeks, and 8 weeks]
  • Generalized Anxiety Disorder 7 Questionnaire [Срок оценки: Baseline, 4 weeks, and 8 weeks]
  • World Health Organization Disability Assessment Schedule 2.0 Short Form [Срок оценки: Baseline, 4 weeks, and 8 weeks]
  • National Institute on Drug Abuse Assist for Alcohol and Substance Use [Срок оценки: Baseline, 4 weeks, and 8 weeks]

Критерии участия

Критерии включения

  • Ages 18 years old and up.
  • Reside in Ontario.
  • Fluent in English.
  • Able to provide autonomous informed consent
  • Reports at least mild depression and/or anxiety symptoms
  • Not currently receiving any psychotherapy or psychosocial interventions.
  • Have access to the internet

Критерии исключения

  • Practical (e.g., scheduling), acute psychiatric (e.g., suicidal ideation nearly every day, recent hospitalization for mental health reasons), or medical reasons (e.g., upcoming surgery, medical procedure, head injury).
  • Not meeting one or more of the above inclusion criteria

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

Канада · 1 центр
  • University of Windsor — Windsor

Идентификаторы

NCT: NCT07088939 · 25-025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗