Effectiveness and Acceptability of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in People With Long COVID-19.
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 for the Transdiagnostic Treatment of Emotional Disorders, Treatment as Usual (TAU).
- Кому может быть актуально
- Состояния в реестре: Long Covid-19, Emotional Disorder, Anxiety, Depression Disorders. 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
- Испания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Обзор
This Randomized Controlled Trial (RCT) aims to assess the effectiveness and acceptability of the Unified Protocol (UP) in an online group format for the treatment of emotional disorders in adults. Participants will be 90 adults (45 in the control group and 45 in the experimental group) with diagnosis of long COVID and comorbid emotional disorders. Participants will be recruited at Hospital Royo Villanova from Zaragoza, Spain. In this study it will be explored whether the changes obtained after the intervention in emotional disorders and cognitive complaints are maintained over 12 months. Additionally, levels of chronic stress will be longitudinally evaluated in the experimental group through accumulated cortisol levels in hair, before and after the application of the UP.
Подробное описание
The COVID-19 disease has caused one of the largest pandemics in history, with significant health, social, and economic negative consequences. A significant proportion of the population has not overcome these negative consequences. It has been found that 10-20% of patients with COVID-19 do not recover their previous health status and develop persistent symptoms over time. This condition has been defined by the WHO as post-COVID-19 condition or long COVID-19, characterized by the presence of physical, cognitive, and emotional symptoms that can last for months or even years after the acute COVID-19 infection. Some of the most prevalent symptoms are fatigue, difficulty breathing, and cognitive dysfunction, in addition to significant psychological impairments. Among these, emotional disorders (ED) are the most commonly reported in this population, including anxiety disorders, depressive disorders, and related conditions.
The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) is a transdiagnostic Cognitive Behavioral Therapy-based pychological intervention, which has proven to be effective for the treatment of emotional disorders in different populations. The UP is focused on improving emotion regulation skills.
The main objective of this randomized controlled trial is to evaluate the effectiveness and acceptability of the Unified Protocol (UP) in an online group format for the treatment of emotional disorders in 90 adults (45 in the control group and 45 in the experimental group) with long COVID and a comorbid emotional disorder. The researchers hypothesize that the application of the UP will result in a significant reduction in emotional symptoms in the experimental group, compared to the control group. To analyze this results, the evolution of symptoms (i.e., anxiety and depressive symptoms, etc.) will be assessed over time (before and after the intervention, as well as up to 12 months follow-up). Additionally, the acceptability and satisfaction of participants after receiving the UP will be analyzed, and it will be examined whether changes in emotional symptoms are associated with changes in long COVID physical symptoms. Changes in cortisol and cortisona levels will be longitudinally examined in the experimental group.
Вмешательства
- Поведенческое Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders
This transdiagnostic psychological intervention is focused on training emotion regulation skills. This program is composed by 8 modules (core modules are 3 to 7). In this study we will use a group online format (videocalls). Each sessin will last 2 hours. The contents of the UP will be distributed in 12 online sessions as follows: * Module 1 (session 1): Setting goals and maintaining motivation. * Module 2 (sessions 2 and 3): Understanding your emotions. * Module 3 (sessions 4 and 5): Mindful - Другое Treatment as Usual (TAU)
This intervention will act as a control condition. During the waiting period (12 weeks) participants assigned to this condition will continue receiving Treatment As Usual at the Royo Villanova Hospital. It consists of regular contact with doctors to monitor the physical symptomsof long COVID-19. After the 12 weeks, participants in this conditions will join the experimental group and they will receive the psychological intervention following the same procedure described for the experimental cond
Первичные конечные точки
- General Depression Severity and Interference Scale (ODSIS; Bentley et al., 2014. Validated in Spanish by Osma et al., 2019) [Срок оценки: Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)]
- General Severity and Interference Scale for Anxiety (OASIS; Norman et al., 2006. Validated in Spanish by Osma et al., 2019) [Срок оценки: Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)]
Вторичные конечные точки (12)
- Memory Failures of Everyday, MFE (Sunderland et al., 1983; Montejo et al., 2014) [Срок оценки: Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)]
- Multidimensional Inventory for Emotional Disorders (MEDI; Rosellini and Brown, 2019. Validated in Spanish by Osma et al., 2023) [Срок оценки: Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)]
- Emotional Regulation Difficulties Scale (DERS; Gratz and Roemer, 2004. Validated in Spanish by Hervás & Jódar, 2008) [Срок оценки: Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)]
- EuroQol (Brooks, 1996. Validated in Spanish by Badia et al., 1999) [Срок оценки: Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)]
- Distress Tolerance Scale (DTS; Sandín et al., 2017) [Срок оценки: Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)]
- Perceived Stress Scale (PSS; Remor y Carrobles, 2001) [Срок оценки: Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)]
- An adaptation of Client Satisfaction Questionnaire (CSQ-8) of Larsen et al., 1979) [Срок оценки: After the treatment is applied (post-assessment; approximately 12 weeks after the intervention starts)]
- Evaluation questionnaire of the UP modules (Ad hoc) [Срок оценки: After the treatment is applied (post-assessment; approximately 12 weeks after the intervention starts)]
- Montreal Cognitive Assessment (MoCA; Nasreddine et al., 2005) [Срок оценки: Only in the experimental group: Before the treatment; at two points follow up (3 and 12 months after the intervention ended)]
- Digit Symbol subtest-Wechsler Adult Intelligence Scale-III (WAIS-III; Wechsler, 1997) [Срок оценки: Only in the experimental group: Before the treatment; at two points follow up (3 and 12 months after the intervention ended)]
- Digit subtest from Wechsler Adult Intelligence Scale-IV (WAIS-IV; Wechsler, 2008) [Срок оценки: Only in the experimental group: Before the treatment; at two points follow up (3 and 12 months after the intervention ended)]
- Cortisol and cortisona levels [Срок оценки: Only in the experimental group: Before the treatment; at two points follow up (3 and 12 months after the intervention ended)]
Критерии участия
Критерии включения
- Residing in Autonomous Community of Aragon (Spain).
- Being at least 18 years old.
- Understanding of Spanish.
- Being diagnosed with long COVID-19: documented SARS-CoV-2 infection and persistence of symptoms beyond 12 weeks after the acute infection.
- Symptoms of depression (ODSIS≥7) and/or anxiety (OASIS≥8).
- Meeting the criteria for an emotional disorder diagnosis.
- Having access to Internet.
- Signing the informed consent.
Критерии исключения
- Pre-existing emotional symptoms prior to the acute SARS-CoV-2 infection.
- Actually receiving psychological treatment.
- Having a diagnosis of severe mental disorder (e.g., personality disorder, bipolar disorder, etc.).
- Active suicidal ideation at the time of the assessment.
- Individuals on psychotropic medication must maintain their dosage throughout the study, unless medically contraindicated.
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
Испания · 2 центра
- Hospital Royo Villanova — Zaragoza
- Hospital Royo Villanova — Zaragoza
Публикации
- Martinez-Borba V, Rodriguez-Marquez AE, Garces-Arilla S, Peris-Baquero O, Navarro-Haro MV, Del Corral-Beamonte E, Osma J. Effectiveness and acceptability of the unified protocol for the transdiagnostic treatment of emotional disorders in people with long COVID-19: Study protocol for a randomized controlled trial. PLoS One. 2026 Feb 17;21(2):e0342908. doi: 10.1371/journal.pone.0342908. eCollection PMID 41701690
Идентификаторы
NCT: NCT06928480 · UP-LONGCOVID-RCT · PROY_S22_24