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

Recruiting · NCT06928480 · Interventional (participants receive a specific treatment) · Lead sponsor: Instituto de Investigación Sanitaria Aragón

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Depression Anxiety

Interventions studied

Treatment as Usual (TAU)Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders

What this trial is about

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.

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

Inclusion criteria

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.

Exclusion criteria

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.

Where it is running

4 locations listed.

Hospital Royo Villanova - Zaragoza, Spain
Hospital Royo Villanova - Zaragoza, Spain
Hospital Royo Villanova - Zaragoza, Zaragoza, Spain
Hospital Royo Villanova - Zaragoza, Zaragoza, Spain

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →