Effectiveness and Acceptability of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in People With Long COVID-19.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- General Depression Severity and Interference Scale (ODSIS; Bentley et al., 2014. Validated in Spanish by Osma et al., 2019)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Unified Protocol Psychological Intervention
The 45 participants assigned to this condition will receive the Unified Protocol psychological intervention through 12 sessions. Weekly session will be conducted online (via Google Meet). Each sessions will last 2 hours.
干预措施: Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (Behavioral)
Control Group-Waiting list
The 45 participants assigned to this condition will remain as a control group on a waiting list for the 12 weeks of the program that participants in the experimental group receive.
干预措施: Treatment as Usual (TAU) (Other)
结局指标
主要结局
General Depression Severity and Interference Scale (ODSIS; Bentley et al., 2014. Validated in Spanish by Osma et al., 2019)
时间窗: Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)
It assesses the frequency, intensity, severity and interference of depressive symptomatology through 5 items. total scores range from 0 to 20 points, higher scores indicating more severe depressive symptoms.
General Severity and Interference Scale for Anxiety (OASIS; Norman et al., 2006. Validated in Spanish by Osma et al., 2019)
时间窗: Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)
It consiste of 5 items that assess the frequency, intensity, severity and interference of anxious symptomatology. Total scores range from 0 to 20 points, higher scores represent more severe anxiety symptoms.
次要结局
- Memory Failures of Everyday, MFE (Sunderland et al., 1983; Montejo et al., 2014)(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)(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)(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)(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)(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)(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)(After the treatment is applied (post-assessment; approximately 12 weeks after the intervention starts))
- Evaluation questionnaire of the UP modules (Ad hoc)(After the treatment is applied (post-assessment; approximately 12 weeks after the intervention starts))
- Montreal Cognitive Assessment (MoCA; Nasreddine et al., 2005)(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)(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)(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(Only in the experimental group: Before the treatment; at two points follow up (3 and 12 months after the intervention ended))
研究者
Jorge Javier Osma López
Principal Investigator, Associate Professor of Psychology
Universidad de Zaragoza