Online Group Therapy Using the Unified Protocol to Treat Emotional Disorders in Adults with Long COVID-19
Led by Instituto de Investigación Sanitaria Aragón · Updated on 2025-05-22
90
Participants Needed
2
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the Unified Protocol UP, a psychological intervention delivered online in a group format, to treat emotional disorders in adults diagnosed with long COVID. This randomized controlled trial involves 90 adults who have long COVID and comorbid emotional disorders such as anxiety and depression. The study aims to assess the effectiveness and acceptability of the UP in improving emotional symptoms and whether these improvements last for up to 12 months. Additionally, chronic stress levels will be monitored through cortisol measurements in hair among participants receiving the UP.
The study includes two groups 45 participants receiving the UP through 12 weekly online sessions of 2 hours each, focusing on emotion regulation skills across eight modules delivered via videoconference. The control group of 45 participants will remain on a waiting list for 12 weeks while receiving usual medical care for their long COVID symptoms. After the waiting period, control group participants will also receive the UP intervention following the same online format.
Participants will be involved in assessments before the treatment, after the 12-week intervention, and at follow-ups at 3, 6, and 12 months. These assessments include questionnaires measuring depression, anxiety, emotional regulation, stress, cognitive complaints, and quality of life. Biological samples will be collected to analyze cortisol levels in the experimental group. Satisfaction and acceptability of the UP will also be evaluated. This study lasts over a year with multiple evaluations to understand the long-term effects of the intervention.
CONDITIONS
Brief Title
Effectiveness and Acceptability of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in People With Long COVID-19.
Research Team
J
Jorge Osma Jorge Osma, PhD
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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 (ODSIS7) and/or anxiety (OASIS8).
Meeting the criteria for an emotional disorder diagnosis.
Having access to Internet.
Signing the informed consent.
You will not qualify if you...
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.
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or online) for assessment and consent
Outpatient Treatment
Duration - 12 weeks
Participants in the experimental group receive the Unified Protocol psychological intervention through 12 weekly online group sessions focused on improving emotion regulation skills. Participants in the control group continue with Treatment As Usual during this time.
Weekly online group sessions (12 sessions total, 2 hours each)
Outpatient Treatment
Duration - 12 weeks
Participants initially in the control group receive the Unified Protocol psychological intervention through 12 weekly online group sessions after their waiting period.
Weekly online group sessions (12 sessions total, 2 hours each)
Follow-up
Duration - 12 months
Participants are monitored to assess the long-term effects of the intervention with evaluations at 3, 6, and 12 months after treatment completion.
Assessments at 3, 6, and 12 months post-intervention
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
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.
Verónica Martínez-Borba, Andrés E Rodríguez-Márquez, Sara Garcés-Arilla...