This Randomized Controlled Trial (RCT) aims to assess the effectiveness and acceptabilityof the Unified Protocol (UP) in an online group format for the treatment of emotionaldisorders in adults. Participants will be 90 adults (45 in the control group and 45 inthe 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 inemotional disorders and cognitive complaints are maintained over 12 months. Additionally,levels of chronic stress will be longitudinally evaluated in the experimental groupthrough accumulated cortisol levels in hair, before and after the application of the UP.
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.
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.
Inclusion Criteria:
- Residing in Autonomous Community of Aragon (Spain).
- Being at least 18 years old.
- Understanding of Spanish.
- Being diagnosed with long COVID-19: documented SARS-CoV-2 infection and persistence
of symptoms beyond 12 weeks after the acute infection.
- Symptoms of depression (ODSIS≥7) and/or anxiety (OASIS≥8).
- Meeting the criteria for an emotional disorder diagnosis.
- Having access to Internet.
- Signing the informed consent.
Exclusion Criteria:
- Pre-existing emotional symptoms prior to the acute SARS-CoV-2 infection.
- Actually receiving psychological treatment.
- Having a diagnosis of severe mental disorder (e.g., personality disorder, bipolar
disorder, etc.).
- Active suicidal ideation at the time of the assessment.
- Individuals on psychotropic medication must maintain their dosage throughout the
study, unless medically contraindicated.
Hospital Royo Villanova
Zaragoza, Spain
Investigator: Jorge Osma Jorge Osma, PhD
Contact: +34 978645390
osma@unizar.es
Jorge Osma Jorge Osma, PhD
+34 978645390
osma@unizar.es
Not Provided