NCT06928480

Effectiveness and Acceptability of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in People With Long COVID-19.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Instituto de Investigación Sanitaria Aragón · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Randomized Controlled Trial (RCT) aims to assess the effectiveness and acceptability of the Unified Protocol (UP) in an online group format for the treatment of emotional disorders in adults. Participants will be 90 adults (45 in the control group and 45 in the experimental group) with diagnosis of long COVID and comorbid emotional disorders. Participants will be recruited at Hospital Royo Villanova from Zaragoza, Spain. In this study it will be explored whether the changes obtained after the intervention in emotional disorders and cognitive complaints are maintained over 12 months. Additionally, levels of chronic stress will be longitudinally evaluated in the experimental group through accumulated cortisol levels in hair, before and after the application of the UP.

Detailed description

The COVID-19 disease has caused one of the largest pandemics in history, with significant health, social, and economic negative consequences. A significant proportion of the population has not overcome these negative consequences. It has been found that 10-20% of patients with COVID-19 do not recover their previous health status and develop persistent symptoms over time. This condition has been defined by the WHO as post-COVID-19 condition or long COVID-19, characterized by the presence of physical, cognitive, and emotional symptoms that can last for months or even years after the acute COVID-19 infection. Some of the most prevalent symptoms are fatigue, difficulty breathing, and cognitive dysfunction, in addition to significant psychological impairments. Among these, emotional disorders (ED) are the most commonly reported in this population, including anxiety disorders, depressive disorders, and related conditions. The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) is a transdiagnostic Cognitive Behavioral Therapy-based pychological intervention, which has proven to be effective for the treatment of emotional disorders in different populations. The UP is focused on improving emotion regulation skills. The main objective of this randomized controlled trial is to evaluate the effectiveness and acceptability of the Unified Protocol (UP) in an online group format for the treatment of emotional disorders in 90 adults (45 in the control group and 45 in the experimental group) with long COVID and a comorbid emotional disorder. The researchers hypothesize that the application of the UP will result in a significant reduction in emotional symptoms in the experimental group, compared to the control group. To analyze this results, the evolution of symptoms (i.e., anxiety and depressive symptoms, etc.) will be assessed over time (before and after the intervention, as well as up to 12 months follow-up). Additionally, the acceptability and satisfaction of participants after receiving the UP will be analyzed, and it will be examined whether changes in emotional symptoms are associated with changes in long COVID physical symptoms. Changes in cortisol and cortisona levels will be longitudinally examined in the experimental group.

Conditions

• Long Covid-19
• Emotional Disorder
• Anxiety
• Depression Disorders
• Emotion Regulation

Interventions

Type	Name	Description
BEHAVIORAL	Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders	This transdiagnostic psychological intervention is focused on training emotion regulation skills. This program is composed by 8 modules (core modules are 3 to 7). In this study we will use a group online format (videocalls). Each sessin will last 2 hours. The contents of the UP will be distributed in 12 online sessions as follows: * Module 1 (session 1): Setting goals and maintaining motivation. * Module 2 (sessions 2 and 3): Understanding your emotions. * Module 3 (sessions 4 and 5): Mindful Emotions Awareness. * Module 4 (sessions 6 and 7): Flexible thinking. * Module 5 (session 8): Emotional baheviors. * Module 6 (session 9): Facing physical sensations. * Module 7 (sessions 10 and 11): Emotionl exposures. * Module 8 (Session 12): Relapse prevention.
OTHER	Treatment as Usual (TAU)	This intervention will act as a control condition. During the waiting period (12 weeks) participants assigned to this condition will continue receiving Treatment As Usual at the Royo Villanova Hospital. It consists of regular contact with doctors to monitor the physical symptomsof long COVID-19. After the 12 weeks, participants in this conditions will join the experimental group and they will receive the psychological intervention following the same procedure described for the experimental condition.

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-04-15
• Last updated: 2025-05-22

Locations

2 sites across 1 country: Spain