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

NCT05581277 | Unknown

• 1 other identifier: PUCPCovid
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Emotional Disorder; Post COVID-19 Condition; Anxiety Disorders; Depressive Disorder

Outcome Measures

Primary Outcomes (6)

• 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

  Pre-treatment

• Adjustment disorders

  Adjustment disorders will be evaluated according to DSM-5 criteria.

  Pre-treatment

Secondary Outcomes (7)

• The Multidimensional Emotional Disorder Inventory (MEDI)

  Up to 12 months

• Health-related quality of life (EuroQol-5D)

  Up to 12 months

• Difficulties in Emotion Regulation Scale (DERS)

  Up to 12 months

• Distress Tolerance Scale (DTS)

  Up to 12 months

• Adaptation of Client Satisfaction Questionnaire [CSQ-8]

  Up to 12 months

Study Arms (3)

Active Comparator: 6 days before intervention

ACTIVE COMPARATOR

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

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.

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.

Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders

Interventions

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.

Active Comparator: 10 days before intervention; Active Comparator: 6 days before intervention; Active Comparator: 8 days before intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Investigación Sanitaria Aragón: lead

Study Sites (2)

Lozano Blesa Clinical University Hospital

Zaragoza, Aragon, 50009, Spain

RECRUITING

Jorge Osma

Teruel, 44003, Spain

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 37920733 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depressive Disorder

Condition Hierarchy (Ancestors)

Mental Disorders; Mood Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will know the baseline condition they have been assigned to: 6, 8 or 10 evaluation days before the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 14, 2022
• Study Start: January 15, 2023
• Primary Completion: June 15, 2023
• Study Completion: September 30, 2023
• Last Updated: March 9, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)