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

Anxiety Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05581277
• Other study ID #: PUCPCovid
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: October 2022
• Source: Instituto de Investigación Sanitaria Aragón
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 30, 2023
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• COVID-19
• Depressive Disorder
• Disease
• Emotional Disorder
• Mood Disorders

Intervention

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.

Locations

Country	Name	City	State
Spain	Jorge Osma	Teruel
Spain	Lozano Blesa Clinical University Hospital	Zaragoza	Aragón

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Sanitaria Aragón

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Anxiety and related disorders interview (ADIS-5)	Structured interview following DSM-5 criteria for anxiety, mood and related disorders	Pre-treatment
Primary	Adjustment disorders	Adjustment disorders will be evaluated according to DSM-5 criteria.	Pre-treatment
Secondary	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
Secondary	Health-related quality of life (EuroQol-5D)	Evaluation through 5 items of quality of life.	Up to 12 months
Secondary	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
Secondary	Distress Tolerance Scale (DTS)	Assessment through 15 items of distress tolerance	Up to 12 months
Secondary	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
Secondary	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
Secondary	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