Actively Recruiting
Led by Instituto de Investigación Sanitaria Aragón · Updated on 2025-05-22
90
Participants Needed
2
Research Sites
N/A
Total Duration
I
Instituto de Investigación Sanitaria Aragón
Lead Sponsor
H
Hospital Royo Villanova de Zaragoza
Collaborating Sponsor
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
Effectiveness and Acceptability of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in People With Long COVID-19.
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
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
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)
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)
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
Total: 2 locations
1
Hospital Royo Villanova
Zaragoza, Zaragoza, Spain, 50015
Not Yet Recruiting
2
Hospital Royo Villanova
Zaragoza, Spain
Actively Recruiting
J
Jorge Osma Jorge Osma, PhD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Verónica Martínez-Borba, Andrés E Rodríguez-Márquez, Sara Garcés-Arilla...
https://pubmed.ncbi.nlm.nih.gov/41701690