Effectiveness and Acceptability of the Unified Protocol for the Transdiagnostic Treatment
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
| Condition(s) | Long Covid-19, Emotional Disorder, Anxiety, Depression Disorders, Emotion Regulation |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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 mus |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Instituto de Investigación Sanitaria Aragón |
| Locations | Zaragoza, Zaragoza, Spain; Zaragoza, Spain |
| Start date | 2025-05-01 |
| NCT ID | NCT06928480 |
| Official listing | https://clinicaltrials.gov/study/NCT06928480 |