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

NCT06928480 | Recruiting

• 2 other identifiers: UP-LONGCOVID-RCTPROY_S22_24
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Long COVID-19; Emotional Disorders; Emotion regulation skills; Unified Protocol; Transdiagnostic; Psychological; Cognitive Behavioral

Outcome Measures

Primary Outcomes (2)

• 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.

  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)

  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.

  Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)

Secondary Outcomes (12)

• Memory Failures of Everyday, MFE (Sunderland et al., 1983; Montejo et al., 2014)

  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)

  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)

  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)

  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)

  Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)

Other Outcomes (3)

• Structured interview for anxiety disorders and related disorders, according to the DSM-5 (ADIS-5; Brown & Barlow, 2014)

  Before the treatment is administered to determine inclusion criteria (approximately 2 weeks before the interventions starts)

• Sociodemographic information

  Before the treatment is administered to characterize the sample (approximately 2 weeks before the interventions starts).

• Long COVID-19 pre-assessment questionnaire

  Before the treatment is administered to characterize the sample (approximately 2 weeks before the interventions starts).

Study Arms (2)

Unified Protocol Psychological Intervention

EXPERIMENTAL

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.

Behavioral: Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders

Control Group-Waiting list

OTHER

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.

Other: Treatment as Usual (TAU)

Interventions

Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders 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.

Unified Protocol Psychological Intervention

Treatment as Usual (TAU) 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.

Control Group-Waiting list

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Investigación Sanitaria Aragón: lead
• Hospital Royo Villanova de Zaragoza: collaborator

Study Sites (2)

Hospital Royo Villanova

Zaragoza, Zaragoza, 50015, Spain

NOT YET RECRUITING

Hospital Royo Villanova

Zaragoza, Spain

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Anxiety Disorders; Emotional Regulation

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders; Self-Control; Social Behavior; Behavior

Central Study Contacts

Jorge Osma Jorge Osma, PhD

CONTACT

+34 978645390; osma@unizar.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Associate Professor of Psychology

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 15, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Access Criteria: Under reasonable request.

Locations

ES (2)