Clinical trial NCT06928480: Effectiveness and Acceptability of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in People With Long COVID-19.
Official title: Effectiveness and Acceptability of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in People With Long COVID-19.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Long Covid-19
Emotional Disorder
Anxiety
Depression Disorders
Emotion Regulation
Keywords: Long COVID-19
Emotional Disorders
Emotion regulation skills
Unified Protocol
Transdiagnostic
Psychological
Cognitive Behavioral
Lead sponsor: Instituto de Investigación Sanitaria Aragón
Sponsor class: OTHER
Collaborators: name: Hospital Royo Villanova de Zaragoza
First posted: 2025-04-15
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The COVID-19 disease has caused one of the largest pandemics in history, with significant health, social, and economic negative consequences. A significant proportion of the population has not overcome these negative consequences. It has been found that 10-20% of patients with COVID-19 do not recover their previous health status and develop persistent symptoms over time. This condition has been defined by the WHO as post-COVID-19 condition or long COVID-19, characterized by the presence of physical, cognitive, and emotional symptoms that can last for months or even years after the acute COVID-19 infection. Some of the most prevalent symptoms are fatigue, difficulty breathing, and cognitive dysfunction, in addition to significant psychological impairments. Among these, emotional disorders (ED) are the most commonly reported in this population, including anxiety disorders, depressive disorders, and related conditions.

The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) is a transdiagnostic Cognitive Behavioral Therapy-based pychological intervention, which has proven to be effective for the treatment of emotional disorders in different populations. The UP is focused on improving emotion regulation skills.

The main objective of this randomized controlled trial is to evaluate the effectiveness and acceptability of the Unified Protocol (UP) in an online group format for the treatment of emotional disorders in 90 adults (45 in the control group and 45 in the experimental group) with long COVID and a comorbid emotional disorder. The researchers hypothesize that the application of the UP will result in a significant reduction in emotional symptoms in the experimental group, compared to the control group. To analyze this results, the evolution of symptoms (i.e., anxiety and depressive symptoms, etc.) will be assessed over time (before and after the intervention, as well as up to 12 months follow-up). Additionally, the acceptability and satisfaction of participants after receiving the UP will be analyzed, and it will be examined whether changes in emotional symptoms are associated with changes in long COVID physical symptoms. Changes in cortisol and cortisona levels will be longitudinally examined in the experimental group.

Eligibility criteria: 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.

Primary outcomes:
measure: General Depression Severity and Interference Scale (ODSIS; Bentley et al., 2014. Validated in Spanish by Osma et al., 2019)
timeFrame: Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)
measure: General Severity and Interference Scale for Anxiety (OASIS; Norman et al., 2006. Validated in Spanish by Osma et al., 2019)
timeFrame: Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)
Secondary outcomes:
measure: Memory Failures of Everyday, MFE (Sunderland et al., 1983; Montejo et al., 2014)
timeFrame: Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)
measure: Multidimensional Inventory for Emotional Disorders (MEDI; Rosellini and Brown, 2019. Validated in Spanish by Osma et al., 2023)
timeFrame: Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)
measure: Emotional Regulation Difficulties Scale (DERS; Gratz and Roemer, 2004. Validated in Spanish by Hervás & Jódar, 2008)
timeFrame: Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)
measure: EuroQol (Brooks, 1996. Validated in Spanish by Badia et al., 1999)
timeFrame: Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)
measure: Distress Tolerance Scale (DTS; Sandín et al., 2017)
timeFrame: Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)
measure: Perceived Stress Scale (PSS; Remor y Carrobles, 2001)
timeFrame: Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)
measure: An adaptation of Client Satisfaction Questionnaire (CSQ-8) of Larsen et al., 1979)
timeFrame: After the treatment is applied (post-assessment; approximately 12 weeks after the intervention starts)
measure: Evaluation questionnaire of the UP modules (Ad hoc)
timeFrame: After the treatment is applied (post-assessment; approximately 12 weeks after the intervention starts)
measure: Montreal Cognitive Assessment (MoCA; Nasreddine et al., 2005)
timeFrame: Only in the experimental group: Before the treatment; at two points follow up (3 and 12 months after the intervention ended)
measure: Digit Symbol subtest-Wechsler Adult Intelligence Scale-III (WAIS-III; Wechsler, 1997)
timeFrame: Only in the experimental group: Before the treatment; at two points follow up (3 and 12 months after the intervention ended)
measure: Digit subtest from Wechsler Adult Intelligence Scale-IV (WAIS-IV; Wechsler, 2008)
timeFrame: Only in the experimental group: Before the treatment; at two points follow up (3 and 12 months after the intervention ended)
measure: Cortisol and cortisona levels
timeFrame: Only in the experimental group: Before the treatment; at two points follow up (3 and 12 months after the intervention ended)
Other outcomes:
measure: Structured interview for anxiety disorders and related disorders, according to the DSM-5 (ADIS-5; Brown & Barlow, 2014)
timeFrame: Before the treatment is administered to determine inclusion criteria (approximately 2 weeks before the interventions starts)
measure: Sociodemographic information
timeFrame: Before the treatment is administered to characterize the sample (approximately 2 weeks before the interventions starts).
measure: Long COVID-19 pre-assessment questionnaire
timeFrame: Before the treatment is administered to characterize the sample (approximately 2 weeks before the interventions starts).
Locations:
city: Zaragoza
country: Spain
facility: Hospital Royo Villanova
city: Zaragoza
country: Spain
facility: Hospital Royo Villanova
Study officials:
References: