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Набор скоро начнётся NCT07432906

Blended Unified Protocol for Emotional Disorders in Primary Care

Без фазы С лечением Emotional Disorders Anxiety Depression

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: Unified Protocol.
Кому может быть актуально
Состояния в реестре: Emotional Disorders, Anxiety, Depression. 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
Turkey (Türkiye)
Следующий шаг
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Официальное название

Feasibility and Preliminary Efficacy of the Unified Protocol in a Blended Format for Emotional Disorders in Primary Care: A Pilot Randomized Controlled Trial

Обзор

The goal of this clinical trial is to learn if a "blended" therapy format (combining face-to-face therapy sessions with a smartphone app) works to treat emotional disorders, such as depression and anxiety, in adults. It will also see if this blended format is feasible and acceptable for patients in primary care settings. The main questions it aims to answer are: Does the blended therapy format reduce symptoms of depression and anxiety? Is the blended format as effective as standard face-to-face therapy? Do participants find the smartphone app easy and helpful to use? Researchers will compare the blended therapy group to a standard face-to-face therapy group and a wait-list control group to see if the blended approach works well. Participants will: Attend therapy sessions based on the Unified Protocol (a type of cognitive-behavioral therapy) for about 10 weeks. Use a smartphone app to complete exercises and track their emotions (if assigned to the blended group). Answer questionnaires about their symptoms and quality of life at the beginning, at the end of treatment, and 3 months later.

Вмешательства

  • Поведенческое Unified Protocol
    A transdiagnostic cognitive-behavioral intervention consisting of 8 modules targeting emotion regulation mechanisms. It includes psychoeducation, mindful emotion awareness, cognitive flexibility, countering emotional behaviors, and exposure exercises.

Первичные конечные точки

  • Feasibility (Recruitment and Retention Rates) [Срок оценки: Post-treatment (Week 10)]
  • Acceptability (Participant Satisfaction) [Срок оценки: Post-treatment (Week 10)]
Вторичные конечные точки (10)
  • Change in Overall Anxiety Severity and Impairment Scale (OASIS) Score [Срок оценки: Baseline (Week 0), Post-treatment (Week 10), and 3-month follow-up]
  • Change in Overall Depression Severity and Impairment Scale (ODSIS) Score [Срок оценки: Baseline (Week 0), Post-treatment (Week 10), and 3-month follow-up]
  • Change in Multidimensional Emotional Disorder Inventory (MEDI) Score [Срок оценки: Baseline (Week 0), Post-treatment (Week 10), and 3-month follow-up]
  • Change in Difficulties in Emotion Regulation Scale (DERS) Score [Срок оценки: Baseline (Week 0), Post-treatment (Week 10), and 3-month follow-up]
  • Change in Short Form-12 (SF-12) Quality of Life Score [Срок оценки: Baseline (Week 0), Post-treatment (Week 10), and 3-month follow-up]
  • Working Alliance Inventory-Short Revised (WAI-SR) Score [Срок оценки: Post-treatment (Week 10)]
  • System Usability Scale (SUS) Score (Note: Only for Blended Group) [Срок оценки: Post-treatment (Week 10)]
  • App Engagement: Duration of Usage (Note: Only for Blended Group) [Срок оценки: Through the intervention period (Up to Week 10)]
  • App Engagement: Videos Viewed (Note: Only for Blended Group) [Срок оценки: Through the intervention period (Up to Week 10)]
  • App Engagement: Completed Exercises (Note: Only for Blended Group) [Срок оценки: Through the intervention period (Up to Week 10)]

Критерии участия

Критерии включения

  • Aged between 18 and 65 years.
  • Scoring 8 or higher on the Overall Anxiety Severity and Impairment Scale (OASIS) OR the Overall Depression Severity and Impairment Scale (ODSIS), indicating clinical severity.
  • Ownership of a smartphone (Android or iOS) and ability to use mobile applications.
  • Literacy in Turkish.
  • Willingness to participate in the study and sign the informed consent form.

Критерии исключения

  • Diagnosis of bipolar disorder, psychotic disorder, or antisocial personality disorder (assessed via MINI 5.0.0).
  • High risk of suicide (assessed via MINI 5.0.0).
  • Cognitive impairment (Score < 21 on the Montreal Cognitive Assessment - MoCA).
  • Current substance alcohol or drug dependence.
  • Currently receiving another psychological treatment (psychotherapy).
  • Changes in psychopharmacological treatment (medication dosage or type) within the last 3 months (participants must be on a stable dose).

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
Открытое
Основная цель
Лечение

Центры проведения

Turkey (Türkiye) · 1 центр
  • Aydin Adnan Menderes University — Aydın

Идентификаторы

NCT: NCT07432906 · 11-10 · 124R124

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗