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.
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.
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.
Parallel
Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders
BehavioralThis 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.
Treatment as Usual (TAU)
Other interventionThis 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.
General Depression Severity and Interference Scale (ODSIS; Bentley et al., 2014. Validated in Spanish by Osma et al., 2019)
It assesses the frequency, intensity, severity and interference of depressive symptomatology through 5 items. total scores range from 0 to 20 points, higher scores indicating more severe depressive symptoms.
General Severity and Interference Scale for Anxiety (OASIS; Norman et al., 2006. Validated in Spanish by Osma et al., 2019)
It consiste of 5 items that assess the frequency, intensity, severity and interference of anxious symptomatology. Total scores range from 0 to 20 points, higher scores represent more severe anxiety symptoms.
Memory Failures of Everyday, MFE (Sunderland et al., 1983; Montejo et al., 2014)
It assesses the frequency of forgetfulness and memory lapses in daily life. Errors include forgetting names, misplacing objects, difficulties in planning, or lapses in attention.
Multidimensional Inventory for Emotional Disorders (MEDI; Rosellini and Brown, 2019. Validated in Spanish by Osma et al., 2023)
It is composed by 49 items that evaluates the transdiagnostic profile of Emotional Disorders, which is composed of nine dimensions: neurotic temperament, positive temperament, depressed mood, somatic anxiety, arousal activation, social anxiety, intrusive cognitions, traumatic re-experiencing, and avoidance.
Emotional Regulation Difficulties Scale (DERS; Gratz and Roemer, 2004. Validated in Spanish by Hervás & Jódar, 2008)
Evaluation through 36 items of difficulties in emotional regulation by means of 5 subscales: lack of control, rejection, interference, inattention and emotional confusion. Higher scores indicate greater difficulties in emotion regulation.
EuroQol (Brooks, 1996. Validated in Spanish by Badia et al., 1999)
It is composd by 5 items assessing self-perceived health status. Higher scores indicate better quality of life.
Structured interview for anxiety disorders and related disorders, according to the DSM-5 (ADIS-5; Brown & Barlow, 2014)
Diagnostic interview to determine the clinical diagnosis of emotional disorder (ED). The following diagnoses according to the DSM-V are included within the category of emotional disorder: major depressive disorder, dysthymic disorder, panic disorder, agoraphobia, obsessive-compulsive disorder, generalized anxiety disorder, post-traumatic stress disorder, social anxiety disorder, hypochondria, and adjustment disorders. Patients with anxiety disorders not otherwise specified and those with depressive disorders not otherwise specified will also be included in the study.
Sociodemographic information
Ad hoc questionnaire to assess: Sex, age, place of residence, marital status, employment status, lifestyle habits (smoking, alcohol, physical activity, diet), vaccination against SARS-CoV-2 information.
Long COVID-19 pre-assessment questionnaire
This questionnaire is designed to assess the symptoms and impact of long COVID-19 symptoms on patients' daily lives. It evaluates information about physical and cognitive function as well as levels of fatigue and COVID-19 infection history.
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Instituto de Investigación Sanitaria Aragón
Lead sponsor
Universidad de Zaragoza
Sponsor institution
Hospital Royo Villanova de Zaragoza
Collaborator
