Efficacy of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) in People With Post Covid-19 Condition.

Instituto de Investigación Sanitaria Aragón

Status: Enrolling

Conditions: Emotional Disorder; Post COVID-19 Condition; Anxiety Disorders; Depressive Disorder

Treatments: Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

Study type: Interventional

Funder types: Other

Identifiers

NCT05581277

PUCPCovid

Details and patient eligibility

About

The present multiple baseline single case trial will study the efficacy and acceptability of the "Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders" in the treatment of emotional symptomatology and/or emotional disorders in a sample of patients with Post Covid-19 condition.

Full description

COVID-19 disease has caused one of the largest pandemics in world history. Two and a half years after the WHO declared a pandemic status for COVID-19, it is known that about 10-20% of Covid-19 patients fail to recover their initial health status and report persistent symptoms over time. This group of people suffer from what has been defined by the WHO as post-COVID-19 condition. Among this group of patients, the most common symptoms observed are fatigue, shortness of breath and cognitive dysfunction, as well as psychological sequelae. Among the latter, the group of Emotional Disorders ( EDs), a nomenclature that groups anxiety disorders, depressive and related disorders, are those most commonly reported by people with post-COVID-19 condition, with alarmingly high rates of persistent psychological distress (36%), anxiety disorders (22%), depression (21%), post-traumatic stress disorder (20%) and sleep disorders (35%). Therefore, it is necessary to apply intervention programs for the treatment of psychological sequelae derived from post-COVID-19 condition, as well as emotional demands and needs in this population highly affected by the COVID-19 pandemic.

The overall objective of this trial is to study the efficacy and acceptability of the "Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders" (UP) in the treatment of emotional symptomatology and/or ED in a sample of patients with post-COVID-19 condition. The investigators hypothesize that a structured psychological intervention focused on treating emotional dysregulation (the UP), a factor shared by the group of EDs, will generate an improvement in the emotional state of this group of patients.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Belong to the autonomous community of Aragón
• Be at least 18 years of age
• Have a good understanding of Spanish
• SARS CoV 2 infection documented by PCR, Ag test or serology
• Persistence of symptoms beyond 12 weeks after acute SARS CoV 2 infection
• Emotional symptoms (score equal to or greater than 8 points in anxious symptomatology(OASIS) and/or equal to or greater than 7 points in depressive symptomatology (ODSIS)) and/or diagnosis of Emotional disorder (ED)
• Internet access available
• Signed informed consent.

Exclusion criteria

• Participating in the trial "Specialized nutritional intervention and rehabilitative treatment for improvement of quality of life in a cohort of patients with post covid-19 condition"
• That the symptom(s) already existed prior to acute SARS CoV 2 infection
• Receiving psychological and/or pharmacological treatment for a mental disorder at present
• Having a diagnosis of severe mental disorder
• Active suicidal ideation at the time of evaluation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 3 patient groups

Active Comparator: 6 days before intervention

Active Comparator group

Description:

Participants have to complete a pre-treatment assessment (baseline) for 6 days.

Treatment:

Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

Active Comparator: 8 days before intervention

Active Comparator group

Description:

Participants have to complete a pre-treatment assessment (baseline) for 8 days.

Treatment:

Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

Active Comparator: 10 days before intervention

Active Comparator group

Description:

Participants have to complete a pre-treatment assessment (baseline) for 10 days.

Treatment:

Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders