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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Depressive Disorder; Anxiety Disorders; Emotional Disorder; Post COVID-19 Condition
• Intervention / Treatment: Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Teruel, Spain, 44003
    • Not yet recruiting
    • Jorge Osma
    • Contact: Jorge Osma, PhD; Phone Number: 978645390; Email: osma@unizar.es
  • Aragón
    • Zaragoza, Aragón, Spain, 50009
      • Recruiting
      • Lozano Blesa Clinical University Hospital
      • Contact: Jorge Osma; Phone Number: +34 978 61 81 01; Email: operis@unizar.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Comparator: 6 days before intervention; Participants have to complete a pre-treatment assessment (baseline) for 6 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.
Active Comparator: Active Comparator: 8 days before intervention; Participants have to complete a pre-treatment assessment (baseline) for 8 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.
Active Comparator: Active Comparator: 10 days before intervention; 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.

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

Collaborators and Investigators

• Sponsor: Instituto de Investigación Sanitaria Aragón

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2023
• Primary Completion (Anticipated): June 15, 2023
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: October 13, 2022
• First Submitted That Met QC Criteria: October 13, 2022
• First Posted (Actual): October 14, 2022

Study Record Updates

• Last Update Posted (Estimate): March 9, 2023
• Last Update Submitted That Met QC Criteria: March 7, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Depressive Disorder; COVID-19; Disease; Anxiety Disorders; Mood Disorders
• Other Study ID Numbers: PUCPCovid

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No