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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-15

Study Completion Date

2023-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Emotional Disorder Post COVID-19 Condition Anxiety Disorders Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Participants will know the baseline condition they have been assigned to: 6, 8 or 10 evaluation days before the intervention.

Study Groups

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Active Comparator: 6 days before intervention

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

Group Type ACTIVE_COMPARATOR

Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

Intervention Type BEHAVIORAL

This intervention focuses on a wide range of emotional psychopathology, allowing care for comorbid disorders and subclinical or unspecified symptoms, which reduces treatment times and costs, and improves response to treatment. The intervention will be carried out in an online-individual format.

Active Comparator: 8 days before intervention

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

Group Type ACTIVE_COMPARATOR

Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

Intervention Type BEHAVIORAL

This intervention focuses on a wide range of emotional psychopathology, allowing care for comorbid disorders and subclinical or unspecified symptoms, which reduces treatment times and costs, and improves response to treatment. The intervention will be carried out in an online-individual format.

Active Comparator: 10 days before intervention

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

Group Type ACTIVE_COMPARATOR

Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

Intervention Type BEHAVIORAL

This intervention focuses on a wide range of emotional psychopathology, allowing care for comorbid disorders and subclinical or unspecified symptoms, which reduces treatment times and costs, and improves response to treatment. The intervention will be carried out in an online-individual format.

Interventions

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Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

This intervention focuses on a wide range of emotional psychopathology, allowing care for comorbid disorders and subclinical or unspecified symptoms, which reduces treatment times and costs, and improves response to treatment. The intervention will be carried out in an online-individual format.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No