Efficacy of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) in People With Post Covid-19 Condition and Emotional Symptomatology.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Overall Depression Severity and Impairment Scale (ODSIS)
研究概览
简要总结
The present multiple baseline single case trial will study the efficacy and acceptability of the "Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders" in the treatment of emotional symptomatology and/or emotional disorders in a sample of patients with Post Covid-19 condition.
详细描述
COVID-19 disease has caused one of the largest pandemics in world history. Two and a half years after the WHO declared a pandemic status for COVID-19, it is known that about 10-20% of Covid-19 patients fail to recover their initial health status and report persistent symptoms over time. This group of people suffer from what has been defined by the WHO as post-COVID-19 condition. Among this group of patients, the most common symptoms observed are fatigue, shortness of breath and cognitive dysfunction, as well as psychological sequelae. Among the latter, the group of Emotional Disorders ( EDs), a nomenclature that groups anxiety disorders, depressive and related disorders, are those most commonly reported by people with post-COVID-19 condition, with alarmingly high rates of persistent psychological distress (36%), anxiety disorders (22%), depression (21%), post-traumatic stress disorder (20%) and sleep disorders (35%). Therefore, it is necessary to apply intervention programs for the treatment of psychological sequelae derived from post-COVID-19 condition, as well as emotional demands and needs in this population highly affected by the COVID-19 pandemic.
The overall objective of this trial is to study the efficacy and acceptability of the "Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders" (UP) in the treatment of emotional symptomatology and/or ED in a sample of patients with post-COVID-19 condition. The investigators hypothesize that a structured psychological intervention focused on treating emotional dysregulation (the UP), a factor shared by the group of EDs, will generate an improvement in the emotional state of this group of patients.
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
- Single (Participant)
盲法说明
Participants will know the baseline condition they have been assigned to: 6, 8 or 10 evaluation days before the intervention.
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
- •Belong to the autonomous community of Aragón
- •Be at least 18 years of age
- •Have a good understanding of Spanish
- •SARS CoV 2 infection documented by PCR, Ag test or serology
- •Persistence of symptoms beyond 12 weeks after acute SARS CoV 2 infection
- •Emotional symptoms (score equal to or greater than 8 points in anxious symptomatology(OASIS) and/or equal to or greater than 7 points in depressive symptomatology (ODSIS)) and/or diagnosis of Emotional disorder (ED)
- •Internet access available
- •Signed informed consent.
排除标准
- •Participating in the trial "Specialized nutritional intervention and rehabilitative treatment for improvement of quality of life in a cohort of patients with post covid-19 condition"
- •That the symptom(s) already existed prior to acute SARS CoV 2 infection
- •Receiving psychological and/or pharmacological treatment for a mental disorder at present
- •Having a diagnosis of severe mental disorder
- •Active suicidal ideation at the time of evaluation.
结局指标
主要结局
Overall Depression Severity and Impairment Scale (ODSIS)
时间窗: Up to 12 months
Consist of five items that evaluate the frequency and the intensity of depressive symptoms and their interference with the person's work or school life and social life. The total score range from 0 to 20 and responses use a 5-point Likert scale ranging from 0 to 4. Higher scores are indicative of greater severity and functional impairment as a result of depressive symptoms.
Table of symptoms referred by the patient
时间窗: Up to 12 months
To facilitate the collection of symptoms referred by the patient regarding CPCOVID, we have developed a table in which different symptoms present in this condition are collected, grouped into the following categories: General Symptoms, Respiratory Symptoms, Gastrointestinal Symptoms, Musculoskeletal Symptoms, Cutaneous Symptoms, Otolaryngological Symptoms, Neurological Symptoms, Cardiovascular Symptoms, Psychological Symptoms and Others
Adjustment disorders
时间窗: Pre-treatment
Adjustment disorders will be evaluated according to DSM-5 criteria.
Overall Anxiety Severity and Impairment Scale (OASIS)
时间窗: Up to 12 months
Consist of five items that evaluate the frequency and the intensity of anxious symptoms and their interference with the person's work or school life and social life. The total score range from 0 to 20 and responses use a 5-point Likert scale ranging from 0 to 4. Higher scores are indicative of greater severity and functional impairment as a result of anxious symptoms.
Sociodemographic data
时间窗: Pre-treatment
sex, age, place of residence (zip code), marital status, employment status, lifestyle habits (smoking, alcohol, physical activity, diet), SARS CoV 2 vaccination (Yes/No prior to infection, number and date of doses, brand of vaccine)
Anxiety and related disorders interview (ADIS-5)
时间窗: Pre-treatment
Structured interview following DSM-5 criteria for anxiety, mood and related disorders
次要结局
- Distress Tolerance Scale (DTS)(Up to 12 months)
- Adaptation of Client Satisfaction Questionnaire [CSQ-8](Up to 12 months)
- Evaluation questionnaire of the Unified Protocol (UP) modules(Up to 12 months)
- Difficulties in Emotion Regulation Scale (DERS)(Up to 12 months)
- Baseline assessment questionnaire(Up to 12 months)
- The Multidimensional Emotional Disorder Inventory (MEDI)(Up to 12 months)
- Health-related quality of life (EuroQol-5D)(Up to 12 months)