Effectiveness and Acceptability of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in People With Long COVID-19.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders, Treatment as Usual (TAU).
- Who it may be relevant to
- Registry conditions: Long Covid-19, Emotional Disorder, Anxiety, Depression Disorders. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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 - 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 cond
Primary outcome measures
- General Depression Severity and Interference Scale (ODSIS; Bentley et al., 2014. Validated in Spanish by Osma et al., 2019) [Time frame: Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)]
- General Severity and Interference Scale for Anxiety (OASIS; Norman et al., 2006. Validated in Spanish by Osma et al., 2019) [Time frame: Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)]
Secondary outcome measures (12)
- Memory Failures of Everyday, MFE (Sunderland et al., 1983; Montejo et al., 2014) [Time frame: Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)]
- Multidimensional Inventory for Emotional Disorders (MEDI; Rosellini and Brown, 2019. Validated in Spanish by Osma et al., 2023) [Time frame: Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)]
- Emotional Regulation Difficulties Scale (DERS; Gratz and Roemer, 2004. Validated in Spanish by Hervás & Jódar, 2008) [Time frame: Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)]
- EuroQol (Brooks, 1996. Validated in Spanish by Badia et al., 1999) [Time frame: Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)]
- Distress Tolerance Scale (DTS; Sandín et al., 2017) [Time frame: Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)]
- Perceived Stress Scale (PSS; Remor y Carrobles, 2001) [Time frame: Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)]
- An adaptation of Client Satisfaction Questionnaire (CSQ-8) of Larsen et al., 1979) [Time frame: After the treatment is applied (post-assessment; approximately 12 weeks after the intervention starts)]
- Evaluation questionnaire of the UP modules (Ad hoc) [Time frame: After the treatment is applied (post-assessment; approximately 12 weeks after the intervention starts)]
- Montreal Cognitive Assessment (MoCA; Nasreddine et al., 2005) [Time frame: Only in the experimental group: Before the treatment; at two points follow up (3 and 12 months after the intervention ended)]
- Digit Symbol subtest-Wechsler Adult Intelligence Scale-III (WAIS-III; Wechsler, 1997) [Time frame: Only in the experimental group: Before the treatment; at two points follow up (3 and 12 months after the intervention ended)]
- Digit subtest from Wechsler Adult Intelligence Scale-IV (WAIS-IV; Wechsler, 2008) [Time frame: Only in the experimental group: Before the treatment; at two points follow up (3 and 12 months after the intervention ended)]
- Cortisol and cortisona levels [Time frame: Only in the experimental group: Before the treatment; at two points follow up (3 and 12 months after the intervention ended)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Spain · 2 centers
- Hospital Royo Villanova — Zaragoza
- Hospital Royo Villanova — Zaragoza
Publications
- Martinez-Borba V, Rodriguez-Marquez AE, Garces-Arilla S, Peris-Baquero O, Navarro-Haro MV, Del Corral-Beamonte E, Osma J. Effectiveness and acceptability of the unified protocol for the transdiagnostic treatment of emotional disorders in people with long COVID-19: Study protocol for a randomized controlled trial. PLoS One. 2026 Feb 17;21(2):e0342908. doi: 10.1371/journal.pone.0342908. eCollection PMID 41701690
Identifiers
NCT: NCT06928480 · UP-LONGCOVID-RCT · PROY_S22_24