Emotional DisorderNCT05581277
Efficacy of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) in People With Post Covid-19 Condition.
A study testing Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in people with Emotional Disorder and Post COVID-19 Condition, run by Instituto de Investigación Sanitaria Aragón at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emotional Disorder, Post COVID-19 Condition, Anxiety Disorders
- What is being tested?
- Unified Protocol for Transdiagnostic Treatment of Emotional Disorders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesSpain
- Study dates
- 15 Jan 2023to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Not yet recruiting
Jorge Osma
Teruel, 44003
Jorge Osma, PhD, 978645390, osma@unizar.es
- Recruiting
Lozano Blesa Clinical University Hospital
Zaragoza, Aragon, 50009
Jorge Osma, 978 61 81 01 ext. +34, operis@unizar.es
About this study
Official title: Efficacy of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) in People With Post Covid-19 Condition and Emotional Symptomatology.
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.
Read the 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.
- Being tested
- Unified Protocol for Transdiagnostic Treatment of Emotional Disorders
- Medical subject headings
- Anxiety Disorders, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unified Protocol for Transdiagnostic Treatment of Emotional DisordersBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: 6 days before intervention | Active comparator | Participants have to complete a pre-treatment assessment (baseline) for 6 days. Receives: Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders |
| Active Comparator: 8 days before intervention | Active comparator | Participants have to complete a pre-treatment assessment (baseline) for 8 days. Receives: Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders |
| Active Comparator: 10 days before intervention | Active comparator | Participants have to complete a pre-treatment assessment (baseline) for 10 days. Receives: Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: Up to 12 months
Anxiety and related disorders interview (ADIS-5)
Structured interview following DSM-5 criteria for anxiety, mood and related disorders
Measured: Pre-treatment
Adjustment disorders
Adjustment disorders will be evaluated according to DSM-5 criteria.
Measured: Pre-treatment
Secondary outcomes (7)
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
Measured: Up to 12 months
Health-related quality of life (EuroQol-5D)
Evaluation through 5 items of quality of life.
Measured: 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
Measured: Up to 12 months
Distress Tolerance Scale (DTS)
Assessment through 15 items of distress tolerance
Measured: 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.
Measured: 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
Measured: 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
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start15 Jan 2023
- Primary completion15 Jun 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emotional DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria Aragón
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05581277
- Sponsor's protocol ID
- PUCPCovid
- Status last verified
- Oct 2022
- First submitted
- 13 Oct 2022
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37920733
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) in People With Post Covid-19 Condition and Emotional Symptomatology.
- ClinicalTrials.gov ID
- NCT05581277
- Acronym / sponsor ID
- PUCPCovid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Instituto de Investigación Sanitaria AragónUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 15 Jun 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 14 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: 6 days before intervention | Active comparator | Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional DisordersParticipants have to complete a pre-treatment assessment (baseline) for 6 days. |
| Active Comparator: 8 days before intervention | Active comparator | Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional DisordersParticipants have to complete a pre-treatment assessment (baseline) for 8 days. |
| Active Comparator: 10 days before intervention | Active comparator | Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional DisordersParticipants have to complete a pre-treatment assessment (baseline) for 10 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unified Protocol for Transdiagnostic Treatment of Emotional DisordersThis 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. | Behavioural | Active Comparator: 10 days before intervention, Active Comparator: 6 days before intervention, Active Comparator: 8 days before intervention |
Primary outcome
Sociodemographic data
Time frame: Pre-treatment
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
Time frame: Up to 12 months
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)
Time frame: Up to 12 months
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)
Time frame: Up to 12 months
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)
Time frame: Pre-treatment
Structured interview following DSM-5 criteria for anxiety, mood and related disorders
Adjustment disorders
Time frame: Pre-treatment
Adjustment disorders will be evaluated according to DSM-5 criteria.
7 secondary outcomes
The Multidimensional Emotional Disorder Inventory (MEDI)
Time frame: Up to 12 months
Health-related quality of life (EuroQol-5D)
Time frame: Up to 12 months
Difficulties in Emotion Regulation Scale (DERS)
Time frame: Up to 12 months
Distress Tolerance Scale (DTS)
Time frame: Up to 12 months
Adaptation of Client Satisfaction Questionnaire [CSQ-8]
Time frame: Up to 12 months
Evaluation questionnaire of the Unified Protocol (UP) modules
Time frame: Up to 12 months
Baseline assessment questionnaire
Time frame: Up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
- Derived from this study: PubMed 37920733Martinez-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in people with Emotional Disorder and Post COVID-19 Condition, run by Instituto de Investigación Sanitaria Aragón at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sociodemographic data (time frame: Pre-treatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05581277, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2023.