Efficacy of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) in People With Post Covid-19 Condition.

Study 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.

Official Title
-----------------
Efficacy of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) in People With Post Covid-19 Condition and Emotional Symptomatology.

Conditions
-----------------
Emotional Disorder, Post COVID-19 Condition, Anxiety Disorders, Depressive Disorder

Intervention / Treatment
-----------------
* Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: In the present investigation, all consecutive patients presenting post covid-19 condition and symptoms of anxiety or depression are requested to participate. Once inclusion criteria are accomplished, each patient will be randomly assigned to one of the multiple baseline groups: 6, 8 or 10 days of assessment before the intervention. The study includes seven assessment points (baseline, pre-treatment, post-treatment and four follow-ups, at one, three, six and twelve months after completion of treatment).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Comparator: 6 days before intervention<br>Participants have to complete a pre-treatment assessment (baseline) for 6 days. | Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders<br>* This intervention focuses on a wide range of emotional psychopathology, allowing care for comorbid disorders and subclinical or unspecified symptoms, which reduces treatment times and costs, and improves response to treatment. The intervention will be carried out in an online-individual format.<br>|
| Active Comparator: Active Comparator: 8 days before intervention<br>Participants have to complete a pre-treatment assessment (baseline) for 8 days. | Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders<br>* This intervention focuses on a wide range of emotional psychopathology, allowing care for comorbid disorders and subclinical or unspecified symptoms, which reduces treatment times and costs, and improves response to treatment. The intervention will be carried out in an online-individual format.<br>|
| Active Comparator: Active Comparator: 10 days before intervention<br>Participants have to complete a pre-treatment assessment (baseline) for 10 days. | Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders<br>* This intervention focuses on a wide range of emotional psychopathology, allowing care for comorbid disorders and subclinical or unspecified symptoms, which reduces treatment times and costs, and improves response to treatment. The intervention will be carried out in an online-individual format.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sociodemographic data | 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) | Pre-treatment | 
| Table of symptoms referred by the patient | 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 | Up to 12 months | 
| Overall Anxiety Severity and Impairment Scale (OASIS) | 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. | Up to 12 months | 
| Overall Depression Severity and Impairment Scale (ODSIS) | 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. | Up to 12 months | 
| Anxiety and related disorders interview (ADIS-5) | Structured interview following DSM-5 criteria for anxiety, mood and related disorders | Pre-treatment | 
| Adjustment disorders | Adjustment disorders will be evaluated according to DSM-5 criteria. | Pre-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Multidimensional Emotional Disorder Inventory (MEDI) | A self-report measure that includes only 49 items and enables to quickly assess the main transdiagnostic dimensions of Emotional disorders | Up to 12 months | 
| Health-related quality of life (EuroQol-5D) | Evaluation through 5 items of quality of life. | Up to 12 months | 
| Difficulties in Emotion Regulation Scale (DERS) | Consists of 36-item of six facets of emotion regulation. Items are rated on a scale of 1 (almost never [0-10%]) to 5 (almost always [91-100%]). Higher scores indicate more difficulty in emotion regulation | Up to 12 months | 
| Distress Tolerance Scale (DTS) | Assessment through 15 items of distress tolerance | Up to 12 months | 
| Adaptation of Client Satisfaction Questionnaire [CSQ-8] | An adaptation of 7 items that measures quality of the intervention and its components, discomfort experienced during treatment and the experience of participating in an online individual format. | Up to 12 months | 
| Evaluation questionnaire of the Unified Protocol (UP) modules | Consists of 7 items that evaluate the usefulness of the program to improve emotional regulation and the usefulness of each of the skills that are worked on in the different UP modules | Up to 12 months | 
| Baseline assessment questionnaire | For the daily baseline assessment, we will use the ODSIS and OASIS questionnaires by modifying the temporality to which the questions refer; changing from during the last week in the original questionnaires to during yesterday in the version used for the baseline assessment | Up to 12 months |