RecruitingNot ApplicableNCT06928480

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

Sponsor

Instituto de Investigación Sanitaria Aragón

Enrollment

90 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

Anxiety Long Covid 19 Emotional Disorder Depression Disorders Emotion Regulation

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests an online emotional health therapy program for people in Spain living with long COVID — where symptoms like fatigue, brain fog, and breathing problems persist for more than 12 weeks after the initial infection. The therapy specifically targets anxiety and depression related to long COVID. **You may be eligible if...** - You are 18 years or older and live in the Aragon region of Spain - You speak Spanish - You were diagnosed with long COVID (symptoms continuing beyond 12 weeks after infection) - You have significant symptoms of anxiety or depression - You have internet access **You may NOT be eligible if...** - You had emotional or mental health symptoms before getting COVID-19 - You are currently receiving psychological treatment - You have a serious mental health diagnosis (such as bipolar disorder or personality disorder) - You have active thoughts of suicide - You are on psychiatric medication and your dose has recently changed Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALUnified 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.

OTHERTreatment 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.