An interventional study of Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Emotional Disorder, Post COVID-19 Condition and Anxiety Disorders, sponsored by Instituto de Investigación Sanitaria Aragón. Status unknown at 2 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-09.
Sponsored by Instituto de Investigación Sanitaria Aragón · Not applicable, Interventional, and Treatment
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.
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.
5,065 studies on the registry are indexed under Anxiety Disorders; 1,408 are open to participants now.
This study's planned enrollment of 60 is below the median of 80 across 4,339 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Instituto de Investigación Sanitaria Aragón is the lead sponsor of 32 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Participants have to complete a pre-treatment assessment (baseline) for 6 days.
Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders
Participants have to complete a pre-treatment assessment (baseline) for 8 days.
Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders
Participants have to complete a pre-treatment assessment (baseline) for 10 days.
Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders
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.
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)
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Up to 12 months
Anxiety and related disorders interview (ADIS-5)
Structured interview following DSM-5 criteria for anxiety, mood and related disorders
Time frame: Pre-treatment
Adjustment disorders
Adjustment disorders will be evaluated according to DSM-5 criteria.
Time frame: Pre-treatment
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
Time frame: Up to 12 months
Health-related quality of life (EuroQol-5D)
Evaluation through 5 items of quality of life.
Time frame: 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
Time frame: Up to 12 months
Distress Tolerance Scale (DTS)
Assessment through 15 items of distress tolerance
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Up to 12 months
Plan to share: No
This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Instituto de Investigación Sanitaria Aragón