Efficacy of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) in People With Post Covid-19 Condition and Emotional Symptomatology.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Emotional Disorder
- Sponsor
- Instituto de Investigación Sanitaria Aragón
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Overall Depression Severity and Impairment Scale (ODSIS)
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Overall Depression Severity and Impairment Scale (ODSIS)
Time Frame: 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
Time Frame: 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
Time Frame: Pre-treatment
Adjustment disorders will be evaluated according to DSM-5 criteria.
Overall Anxiety Severity and Impairment Scale (OASIS)
Time Frame: 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
Time Frame: 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)
Time Frame: Pre-treatment
Structured interview following DSM-5 criteria for anxiety, mood and related disorders
Secondary Outcomes
- 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)