Efficacy of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) in People With Post Covid-19 Condition.
Primary Purpose
Emotional Disorder, Post COVID-19 Condition, Anxiety Disorders
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Unified Protocol for Transdiagnostic Treatment of Emotional Disorders
Sponsored by
About this trial
This is an interventional treatment trial for Emotional Disorder
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
- 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)
- 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.
Sites / Locations
- Lozano Blesa Clinical University HospitalRecruiting
- Jorge Osma
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Active Comparator: 6 days before intervention
Active Comparator: 8 days before intervention
Active Comparator: 10 days before intervention
Arm Description
Participants have to complete a pre-treatment assessment (baseline) for 6 days.
Participants have to complete a pre-treatment assessment (baseline) for 8 days.
Participants have to complete a pre-treatment assessment (baseline) for 10 days.
Outcomes
Primary Outcome Measures
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)
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
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.
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.
Anxiety and related disorders interview (ADIS-5)
Structured interview following DSM-5 criteria for anxiety, mood and related disorders
Adjustment disorders
Adjustment disorders will be evaluated according to DSM-5 criteria.
Secondary Outcome Measures
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
Health-related quality of life (EuroQol-5D)
Evaluation through 5 items of quality of life.
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
Distress Tolerance Scale (DTS)
Assessment through 15 items of distress tolerance
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.
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
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
Full Information
NCT ID
NCT05581277
First Posted
October 13, 2022
Last Updated
March 7, 2023
Sponsor
Instituto de Investigación Sanitaria Aragón
1. Study Identification
Unique Protocol Identification Number
NCT05581277
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2023 (Actual)
Primary Completion Date
June 15, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigación Sanitaria Aragón
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emotional Disorder, Post COVID-19 Condition, Anxiety Disorders, Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
Participant
Masking Description
Participants will know the baseline condition they have been assigned to: 6, 8 or 10 evaluation days before the intervention.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active Comparator: 6 days before intervention
Arm Type
Active Comparator
Arm Description
Participants have to complete a pre-treatment assessment (baseline) for 6 days.
Arm Title
Active Comparator: 8 days before intervention
Arm Type
Active Comparator
Arm Description
Participants have to complete a pre-treatment assessment (baseline) for 8 days.
Arm Title
Active Comparator: 10 days before intervention
Arm Type
Active Comparator
Arm Description
Participants have to complete a pre-treatment assessment (baseline) for 10 days.
Intervention Type
Behavioral
Intervention Name(s)
Unified Protocol for Transdiagnostic Treatment of Emotional Disorders
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sociodemographic data
Description
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)
Time Frame
Pre-treatment
Title
Table of symptoms referred by the patient
Description
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
Time Frame
Up to 12 months
Title
Overall Anxiety Severity and Impairment Scale (OASIS)
Description
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.
Time Frame
Up to 12 months
Title
Overall Depression Severity and Impairment Scale (ODSIS)
Description
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.
Time Frame
Up to 12 months
Title
Anxiety and related disorders interview (ADIS-5)
Description
Structured interview following DSM-5 criteria for anxiety, mood and related disorders
Time Frame
Pre-treatment
Title
Adjustment disorders
Description
Adjustment disorders will be evaluated according to DSM-5 criteria.
Time Frame
Pre-treatment
Secondary Outcome Measure Information:
Title
The Multidimensional Emotional Disorder Inventory (MEDI)
Description
A self-report measure that includes only 49 items and enables to quickly assess the main transdiagnostic dimensions of Emotional disorders
Time Frame
Up to 12 months
Title
Health-related quality of life (EuroQol-5D)
Description
Evaluation through 5 items of quality of life.
Time Frame
Up to 12 months
Title
Difficulties in Emotion Regulation Scale (DERS)
Description
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
Time Frame
Up to 12 months
Title
Distress Tolerance Scale (DTS)
Description
Assessment through 15 items of distress tolerance
Time Frame
Up to 12 months
Title
Adaptation of Client Satisfaction Questionnaire [CSQ-8]
Description
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.
Time Frame
Up to 12 months
Title
Evaluation questionnaire of the Unified Protocol (UP) modules
Description
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
Time Frame
Up to 12 months
Title
Baseline assessment questionnaire
Description
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
Time Frame
Up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Lozano Blesa Clinical University Hospital
City
Zaragoza
State/Province
Aragón
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge Osma
Phone
978 61 81 01
Ext
+34
Email
operis@unizar.es
Facility Name
Jorge Osma
City
Teruel
ZIP/Postal Code
44003
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge Osma, PhD
Phone
978645390
Email
osma@unizar.es
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) in People With Post Covid-19 Condition.
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