This Randomized Controlled Trial (RCT) aims to assess the effectiveness and acceptability of the Unified Protocol (UP) in an online group format for the treatment of emotional disorders in adults. Participants will be 90 adults (45 in the control group and 45 in the experimental group) with diagnosis of long COVID and comorbid emotional disorders. Participants will be recruited at Hospital Royo Villanova from Zaragoza, Spain. In this study it will be explored whether the changes obtained after the intervention in emotional disorders and cognitive complaints are maintained over 12 months. Additionally, levels of chronic stress will be longitudinally evaluated in the experimental group through accumulated cortisol levels in hair, before and after the application of the UP.
The COVID-19 disease has caused one of the largest pandemics in history, with significant health, social, and economic negative consequences. A significant proportion of the population has not overcome these negative consequences. It has been found that 10-20% of patients with COVID-19 do not recover their previous health status and develop persistent symptoms over time. This condition has been defined by the WHO as post-COVID-19 condition or long COVID-19, characterized by the presence of physical, cognitive, and emotional symptoms that can last for months or even years after the acute COVID-19 infection. Some of the most prevalent symptoms are fatigue, difficulty breathing, and cognitive dysfunction, in addition to significant psychological impairments. Among these, emotional disorders (ED) are the most commonly reported in this population, including anxiety disorders, depressive disorders, and related conditions. The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) is a transdiagnostic Cognitive Behavioral Therapy-based pychological intervention, which has proven to be effective for the treatment of emotional disorders in different populations. The UP is focused on improving emotion regulation skills. The main objective of this randomized controlled trial is to evaluate the effectiveness and acceptability of the Unified Protocol (UP) in an online group format for the treatment of emotional disorders in 90 adults (45 in the control group and 45 in the experimental group) with long COVID and a comorbid emotional disorder. The researchers hypothesize that the application of the UP will result in a significant reduction in emotional symptoms in the experimental group, compared to the control group. To analyze this results, the evolution of symptoms (i.e., anxiety and depressive symptoms, etc.) will be assessed over time (before and after the intervention, as well as up to 12 months follow-up). Additionally, the acceptability and satisfaction of participants after receiving the UP will be analyzed, and it will be examined whether changes in emotional symptoms are associated with changes in long COVID physical symptoms. Changes in cortisol and cortisona levels will be longitudinally examined in the experimental group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
This transdiagnostic psychological intervention is focused on training emotion regulation skills. This program is composed by 8 modules (core modules are 3 to 7). In this study we will use a group online format (videocalls). Each sessin will last 2 hours. The contents of the UP will be distributed in 12 online sessions as follows: * Module 1 (session 1): Setting goals and maintaining motivation. * Module 2 (sessions 2 and 3): Understanding your emotions. * Module 3 (sessions 4 and 5): Mindful Emotions Awareness. * Module 4 (sessions 6 and 7): Flexible thinking. * Module 5 (session 8): Emotional baheviors. * Module 6 (session 9): Facing physical sensations. * Module 7 (sessions 10 and 11): Emotionl exposures. * Module 8 (Session 12): Relapse prevention.
This intervention will act as a control condition. During the waiting period (12 weeks) participants assigned to this condition will continue receiving Treatment As Usual at the Royo Villanova Hospital. It consists of regular contact with doctors to monitor the physical symptomsof long COVID-19. After the 12 weeks, participants in this conditions will join the experimental group and they will receive the psychological intervention following the same procedure described for the experimental condition.
Hospital Royo Villanova
Zaragoza, Zaragoza, Spain
NOT_YET_RECRUITINGHospital Royo Villanova
Zaragoza, Spain
RECRUITINGGeneral Depression Severity and Interference Scale (ODSIS; Bentley et al., 2014. Validated in Spanish by Osma et al., 2019)
It assesses the frequency, intensity, severity and interference of depressive symptomatology through 5 items. total scores range from 0 to 20 points, higher scores indicating more severe depressive symptoms.
Time frame: Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)
General Severity and Interference Scale for Anxiety (OASIS; Norman et al., 2006. Validated in Spanish by Osma et al., 2019)
It consiste of 5 items that assess the frequency, intensity, severity and interference of anxious symptomatology. Total scores range from 0 to 20 points, higher scores represent more severe anxiety symptoms.
Time frame: Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)
Memory Failures of Everyday, MFE (Sunderland et al., 1983; Montejo et al., 2014)
It assesses the frequency of forgetfulness and memory lapses in daily life. Errors include forgetting names, misplacing objects, difficulties in planning, or lapses in attention.
Time frame: Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)
Multidimensional Inventory for Emotional Disorders (MEDI; Rosellini and Brown, 2019. Validated in Spanish by Osma et al., 2023)
It is composed by 49 items that evaluates the transdiagnostic profile of Emotional Disorders, which is composed of nine dimensions: neurotic temperament, positive temperament, depressed mood, somatic anxiety, arousal activation, social anxiety, intrusive cognitions, traumatic re-experiencing, and avoidance.
Time frame: Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)
Emotional Regulation Difficulties Scale (DERS; Gratz and Roemer, 2004. Validated in Spanish by Hervás & Jódar, 2008)
Evaluation through 36 items of difficulties in emotional regulation by means of 5 subscales: lack of control, rejection, interference, inattention and emotional confusion. Higher scores indicate greater difficulties in emotion regulation.
Time frame: Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)
EuroQol (Brooks, 1996. Validated in Spanish by Badia et al., 1999)
It is composd by 5 items assessing self-perceived health status. Higher scores indicate better quality of life.
Time frame: Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)
Distress Tolerance Scale (DTS; Sandín et al., 2017)
This scale evaluates, through 15 items, distress tolerance in the following dimensions: 1) Tolerance: perceived ability to tolerate emotional distress; 2) Appraisal: subjective assessment of distress; 3) Absortion: attention absorbed by negative emotions; 4) Regulation: strategies to alleviate distress.
Time frame: Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)
Perceived Stress Scale (PSS; Remor y Carrobles, 2001)
This scale consists of 14 items designed to measure the level of perceived stress in daily life over the past month. The items are rated from 0 to 4, where 0 is "never" and 4 is "very often." Higher total scores indicate greater perceived stress.
Time frame: Before the treatment, after the treatment, at three points follow up (3, 6 and 12 months after the intervention ended)
An adaptation of Client Satisfaction Questionnaire (CSQ-8) of Larsen et al., 1979)
the adaptation made for this study includes 6 of the 8 items of the CSQ-8 (perceived quality, adequacy to previous expectations, recommendation of the treatment to friends or family, usefulness of the techniques learned, general satisfaction with the intervention and probability that they will choose an intervention of this type again) and one additional item related to the discomfort generated by the intervention. Likewise, a change has been made in the Likert response scale from 4 points in the original (0 = "Bad / Not at all" to 4 = "Excellent/Very Much") to 11 in the current one (0 = "Bad / Not at all to 10 = "Excellent/Very Much"). Higher scores represent greater satisfaction with the treatment.
Time frame: After the treatment is applied (post-assessment; approximately 12 weeks after the intervention starts)
Evaluation questionnaire of the UP modules (Ad hoc)
This questionnaire has been elaborated ad hoc. It is composed of 7 questions; one general question that evaluates the usefulness of the program to improve emotional regulation and six specific questions that separately evaluate the usefulness of each of the techniques that are worked on in the different modules of the UP to better regulate emotions . The response scale ranges from 0 (not at all) to 10 (very much). Higher scores represent higher satisfaction with the treatment.
Time frame: After the treatment is applied (post-assessment; approximately 12 weeks after the intervention starts)
Montreal Cognitive Assessment (MoCA; Nasreddine et al., 2005)
Brief neuropsychological test designed to assess mild cognitive impairment. It evaluates multiple cognitive domains, including visuospatial skills, memory, working memory, attention, concentration, language, executive functions, and orientation. It has a maximum score of 30 points, with a common cutoff score of 25 to identify potential cognitive deficits. A score of 25 or lower is considered indicative of cognitive impairment.
Time frame: Only in the experimental group: Before the treatment; at two points follow up (3 and 12 months after the intervention ended)
Digit Symbol subtest-Wechsler Adult Intelligence Scale-III (WAIS-III; Wechsler, 1997)
This cognitive test presents a coding matrix in which the digits from 1 to 9 are paired with a symbol. On the same sheet, a series of digits is displayed with a blank space where participants must draw the corresponding symbol. The task must be completed as quickly as possible, with a 120-second limit to match the symbols with their respective numbers. If participants fail to complete the first four lines within the allotted time, they are given additional time to ensure they gain enough experience with the digit-symbol association. The tota score is based on the number of symbols correctly paired within 120 seconds (maximum score: 133). Immediately after completing the task, the researcher provides the participant with a new sheet containing the digits from 1 to 9 arranged in two lines. In this second part, participants must complete the blank spaces by drawing from memory the symbols corresponding to each number, with no time limit.
Time frame: Only in the experimental group: Before the treatment; at two points follow up (3 and 12 months after the intervention ended)
Digit subtest from Wechsler Adult Intelligence Scale-IV (WAIS-IV; Wechsler, 2008)
The direct order digit task of this subtest evaluates verbal short-term memory and consists of a numeric recall task that measures the mechanical repetition of a sequence of numbers. The reverse order digit task assesses verbal working memory and requires participants to recall a sequence of numbers in reverse order (maximum score: 9). The memory capacity evaluated with these two tasks is defined as the longest sequence that participants can repeat without errors, allowing two attempts for each sequence length (maximum score: 8).
Time frame: Only in the experimental group: Before the treatment; at two points follow up (3 and 12 months after the intervention ended)
Cortisol and cortisona levels
Hair sample will be collected from the posterior vertex or nape area, where growth is continuous and less exposed to contaminants. For this, a small portion of hair will be tied with thread near the cut area, which will allow identification of the portion closest to the scalp at the time of analysis and prevent hair loss. Using clean scissors, the hair will be cut as close as possible to the scalp, obtaining a segment of approximately 3 cm in length. This will allow for the evaluation of cortisol levels accumulated over the last three months, as hair grows on average 1 cm per month.
Time frame: Only in the experimental group: Before the treatment; at two points follow up (3 and 12 months after the intervention ended)
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