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

NCT ID: NCT06928480

Last Updated: 2025-05-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2026-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Unified Protocol Psychological Intervention

The 45 participants assigned to this condition will receive the Unified Protocol psychological intervention through 12 sessions. Weekly session will be conducted online (via Google Meet). Each sessions will last 2 hours.

Group Type: EXPERIMENTAL

Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders

Intervention Type: BEHAVIORAL

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.

Control Group-Waiting list

The 45 participants assigned to this condition will remain as a control group on a waiting list for the 12 weeks of the program that participants in the experimental group receive.

Group Type: OTHER

Treatment as Usual (TAU)

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Royo Villanova de Zaragoza

UNKNOWN

Sponsor Role: collaborator

Instituto de Investigación Sanitaria Aragón

OTHER

Sponsor Role: lead

Responsible Party

Jorge Javier Osma López

Principal Investigator, Associate Professor of Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Royo Villanova

Zaragoza, Zaragoza, Spain

Site Status: NOT_YET_RECRUITING

Hospital Royo Villanova

Zaragoza, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Jorge Osma Jorge Osma, PhD

Role: CONTACT

osma@unizar.es

+34 978645390

Facility Contacts

Jorge Osma Jorge Osma, PhD

Role: primary

osma@unizar.es

+34 978645390

Jorge J Osma, PhD

Role: primary

protocolounificadocovid19@gmail.com

978645390 ext. 861390

Other Identifiers

PROY_S22_24

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

UP-LONGCOVID-RCT

Identifier Type: -

Identifier Source: org_study_id