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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Comparator: 6 days before intervention | Active Comparator | Participants have to complete a pre-treatment assessment (baseline) for 6 days. |
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| Active Comparator: 8 days before intervention | Active Comparator | Participants have to complete a pre-treatment assessment (baseline) for 8 days. |
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| Active Comparator: 10 days before intervention | Active Comparator | Participants have to complete a pre-treatment assessment (baseline) for 10 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unified Protocol for Transdiagnostic Treatment of Emotional Disorders | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sociodemographic data | sex, age, place of residence (zip code), marital status, employment status, lifestyle habits (smoking, alcohol, physical activity, diet), SARS CoV 2 vaccination (Yes/No prior to infection, number and date of doses, brand of vaccine) | Pre-treatment |
| Table of symptoms referred by the patient | To facilitate the collection of symptoms referred by the patient regarding CPCOVID, we have developed a table in which different symptoms present in this condition are collected, grouped into the following categories: General Symptoms, Respiratory Symptoms, Gastrointestinal Symptoms, Musculoskeletal Symptoms, Cutaneous Symptoms, Otolaryngological Symptoms, Neurological Symptoms, Cardiovascular Symptoms, Psychological Symptoms and Others | Up to 12 months |
| Overall Anxiety Severity and Impairment Scale (OASIS) | Consist of five items that evaluate the frequency and the intensity of anxious symptoms and their interference with the person's work or school life and social life. The total score range from 0 to 20 and responses use a 5-point Likert scale ranging from 0 to 4. Higher scores are indicative of greater severity and functional impairment as a result of anxious symptoms. | Up to 12 months |
| Overall Depression Severity and Impairment Scale (ODSIS) | Consist of five items that evaluate the frequency and the intensity of depressive symptoms and their interference with the person's work or school life and social life. The total score range from 0 to 20 and responses use a 5-point Likert scale ranging from 0 to 4. Higher scores are indicative of greater severity and functional impairment as a result of depressive symptoms. | Up to 12 months |
| Anxiety and related disorders interview (ADIS-5) | Structured interview following DSM-5 criteria for anxiety, mood and related disorders |
| Measure | Description | Time Frame |
|---|---|---|
| The Multidimensional Emotional Disorder Inventory (MEDI) | A self-report measure that includes only 49 items and enables to quickly assess the main transdiagnostic dimensions of Emotional disorders | Up to 12 months |
| Health-related quality of life (EuroQol-5D) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lozano Blesa Clinical University Hospital | Recruiting | Zaragoza | Aragon | 50009 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37920733 | Derived | Martinez-Borba V, Martinez-Garcia L, Peris-Baquero O, Osma J, Del Corral-Beamonte E. Unified Protocol for the transdiagnostic treatment of emotional disorders in people with post COVID-19 condition: study protocol for a multiple baseline n-of-1 trial. Front Psychol. 2023 Oct 18;14:1160692. doi: 10.3389/fpsyg.2023.1160692. eCollection 2023. |
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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).
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Participants will know the baseline condition they have been assigned to: 6, 8 or 10 evaluation days before the intervention.
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| Pre-treatment |
| Adjustment disorders | Adjustment disorders will be evaluated according to DSM-5 criteria. | Pre-treatment |
Evaluation through 5 items of quality of life. |
| Up to 12 months |
| Difficulties in Emotion Regulation Scale (DERS) | Consists of 36-item of six facets of emotion regulation. Items are rated on a scale of 1 ("almost never [0-10%]") to 5 ("almost always [91-100%]"). Higher scores indicate more difficulty in emotion regulation | Up to 12 months |
| Distress Tolerance Scale (DTS) | Assessment through 15 items of distress tolerance | Up to 12 months |
| Adaptation of Client Satisfaction Questionnaire [CSQ-8] | An adaptation of 7 items that measures quality of the intervention and its components, discomfort experienced during treatment and the experience of participating in an online individual format. | Up to 12 months |
| Evaluation questionnaire of the Unified Protocol (UP) modules | Consists of 7 items that evaluate the usefulness of the program to improve emotional regulation and the usefulness of each of the skills that are worked on in the different UP modules | Up to 12 months |
| Baseline assessment questionnaire | For the daily baseline assessment, we will use the ODSIS and OASIS questionnaires by modifying the temporality to which the questions refer; changing from "during the last week" in the original questionnaires to "during yesterday" in the version used for the baseline assessment | Up to 12 months |
| Jorge Osma | Not yet recruiting | Teruel | 44003 | Spain |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D019964 | Mood Disorders |
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