NCT06928480Recruiting
Effectiveness and Acceptability of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in People With Long COVID-19.
Source: ClinicalTrials.gov · Last updated 22 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 28 Mar 2025
- Start date
- 1 May 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Instituto de Investigación Sanitaria Aragón
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT06928480
What you commit to
- Study type: Interventional
- Planned participants: 90
- From 1 May 2025 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Pre-existing emotional symptoms prior to the acute SARS-CoV-2 infection.
- Actually receiving psychological treatment.
- Individuals on psychotropic medication must maintain their dosage throughout the study, unless medically contraindicated.
Other illness
- Having a diagnosis of severe mental disorder (e.g., personality disorder, bipolar disorder, etc.).
Other
- Active suicidal ideation at the time of the assessment.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Royo Villanova Coordinator of this site? Confirm its status | Zaragoza | Spain | Not yet recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.