Clinical trial NCT05581277: Efficacy of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) in People With Post Covid-19 Condition.
Official title: Efficacy of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) in People With Post Covid-19 Condition and Emotional Symptomatology.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Emotional Disorder
Post COVID-19 Condition
Anxiety Disorders
Depressive Disorder
Lead sponsor: Instituto de Investigación Sanitaria Aragón
Sponsor class: OTHER
First posted: 2022-10-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In the present investigation, all consecutive patients presenting post covid-19 condition and symptoms of anxiety or depression are requested to participate. Once inclusion criteria are accomplished, each patient will be randomly assigned to one of the multiple baseline groups: 6, 8 or 10 days of assessment before the intervention. The study includes seven assessment points (baseline, pre-treatment, post-treatment and four follow-ups, at one, three, six and twelve months after completion of treatment).
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sociodemographic data
timeFrame: Pre-treatment
measure: Table of symptoms referred by the patient
timeFrame: Up to 12 months
measure: Overall Anxiety Severity and Impairment Scale (OASIS)
timeFrame: Up to 12 months
measure: Overall Depression Severity and Impairment Scale (ODSIS)
timeFrame: Up to 12 months
measure: Anxiety and related disorders interview (ADIS-5)
timeFrame: Pre-treatment
measure: Adjustment disorders
timeFrame: Pre-treatment
Secondary outcomes:
measure: The Multidimensional Emotional Disorder Inventory (MEDI)
timeFrame: Up to 12 months
measure: Health-related quality of life (EuroQol-5D)
timeFrame: Up to 12 months
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: Up to 12 months
measure: Distress Tolerance Scale (DTS)
timeFrame: Up to 12 months
measure: Adaptation of Client Satisfaction Questionnaire [CSQ-8]
timeFrame: Up to 12 months
measure: Evaluation questionnaire of the Unified Protocol (UP) modules
timeFrame: Up to 12 months
measure: Baseline assessment questionnaire
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Lozano Blesa Clinical University Hospital
state: Aragón
city: Teruel
country: Spain
facility: Jorge Osma
Study officials:
References: