Study on the Effectiveness and Differential Usability of the UP in Spanish University Students

Depression, Anxiety Clinical Trial

Official title:

Study on the Efficacy and Differential Usability of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Spanish University Students

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06432829
• Other study ID #: IPES/PU-E/2024
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2024
• Est. completion date: September 15, 2025

Study information

• Verified date: May 2024
• Source: Instituto de Investigación Sanitaria Aragón
• Contact: Jorge Osma, Ph. D.
• Phone: 978645390
• Email: osma[@]unizar.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The present study seeks to compare and analyze the degree of usefulness, acceptability and implementation of the Unified Protocol (UP) in its application in two cost-effective formats, the online group and the blended online group for the treatment of emotional disorders in university students in Spain.

Description:

Introduction: Emotional Disorders (EDs) are the most common disorders among the young population. Despite their high prevalence in university students, data suggest that only 16.4% of students suffering from a mental health disorder receive treatment. Therefore, the present study seeks to compare and analyze the degree of usefulness, acceptability and implementation of the Unified Protocol (UP) in its application in two cost-effective formats, the online group and the Blended online group.

Method: The study population will be university students who meet diagnostic criteria for EDs. We estimate a sample of 70 students, 35 per condition. The intervention will consist of the application of the 8 modules of the UP in two formats: online group format of 8 weekly sessions of 2 hours duration and Blended format (4 online group sessions, of two hours duration in modules 1,4,6 and 7 of the UP + autonomous work through the UP-APP). The variables evaluated will be collected before the intervention, in the post-treatment and in the follow-ups at one month and 3 months.

This study responds to the need to implement services that improve the availability and access to the treatment of EDs in the university context in Spain, and in this particular case, through the formats offered by a transdiagnostic intervention such as the UP.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: September 15, 2025
• Est. primary completion date: September 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Be enrolled at the University of Cordoba (Spain), in any of the degrees

• Have a diagnosis of anxiety or mood disorder from the Structured Interview for Anxiety and Related Disorders, according to the DSM-5 (ADIS-5)*

• Be at least 18 years old

• Be fluent in the Spanish language

• Have a technological device (Computer, Tablet, cell phone) with internet connection

• Have a smartphone device with Android operating system

• In the case of taking pharmacological treatment for the treatment of their ED, maintenance of the same doses and medications for at least 3 months before starting their participation in the study and throughout the treatment

• Signature of the informed consent

Exclusion Criteria:

• Have a diagnosis of Obsessive Compulsive Disorder or Post Traumatic Stress Disorder

• Have a severe condition that requires priority for treatment will not be able to participate in the study. This includes a serious mental disorder (personality disorder, schizophrenia, or an organic mental disorder), suicide risk at the time of assessment, or substance abuse within the past three months.

Related Conditions & MeSH terms

• Depression, Anxiety
• Emotion Regulation
• Emotional Disorder
• Mood Disorders

Intervention

Behavioral:
• Unified Protocol for the transdiagnostic treatment of emotional disorders
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-group format. For ethical reasons, if any of the patients feel uncomfortable during the study with the online-group format, will may leave the group and receive individual attention. The study plans follow-ups at 1 and 3 months after the end of the treatment.

Locations

Country	Name	City	State
Spain	Instituto de investigación sanitaria de Aragón, universidad de Zaragoza	Teruel

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Sanitaria Aragón

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Structured interview for anxiety disorders and related disorders, according to the DSM-5 (ADIS-5; Brown & Barlow, 2014)	Diagnostic interview to determine if the participant has a clinical diagnosis of emotional disorder (ET) and can be part of the study. The following diagnoses according to the DSM-V are included within the category of emotional disorder: major depressive disorder, dysthymic disorder, panic disorder, agoraphobia, obsessive-compulsive disorder, generalized anxiety disorder, post-traumatic stress disorder, social anxiety disorder, hypochondria, and adjustment disorders. Patients with anxiety disorders not otherwise specified and those with depressive disorders not otherwise specified will also be included in the study.	Only before of the treatment to check inclusion criteria
Primary	Questionnaire on Sociodemographic Data (ad hoc)	Information will be collected on sex, age, marital status, employment status, type of study (bachelor's degree; postgraduate: master's degree, continuing education courses; doctorate), degree taken and course in which you are enrolled.	Pre-treatment data
Primary	General Depression Severity and Interference Scale (ODSIS; Bentley et al., 2014. Validated in Spanish by Osma et al., 2019)	Evaluation through 5 items of the frequency, intensity, severity and interference of depressive symptomatology	Up to 3 months follow-up
Primary	General Severity and Interference Scale for Anxiety (OASIS; Norman et al., 2006. Validated in Spanish by Osma et al., 2019)	Evaluation through 5 items of the frequency, intensity, severity and interference of anxious symptomatology	Up to 3 months follow-up
Primary	Multidimensional Inventory for Emotional Disorders (MEDI; Rosellini and Brown, 2019. Validated in Spanish by Osma et al., 2023)	Evaluation through 49 items of 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	Up to 3 months follow-up
Secondary	Emotional Regulation Difficulties Scale (DERS; Gratz and Roemer, 2004. Validated in Spanish by Hervás & Jódar, 2008)	Evaluation through 28 items of difficulties in emotional regulation by means of 5 subscales: lack of control, rejection, interference, inattention and emotional confusion.	Up to 3 months follow-up
Secondary	Emotional Regulation Questionnaire (ERQ; Gross & John, 2003. Validated in Spanish by Pineda et al., 2018)	Evaluation of emotional regulation through 10 items, scored on a scale from 1 (strongly disagree) to 7 (strongly agree), with two subscales: cognitive restructuring and emotional suppression.	Up to 3 months follow-up
Secondary	Short Version of the Five Facets of Mindfulness Questionnaire (FFMQ-SF; Bohlmeijer et al., 2011. Validated in Spanish by Asensio-Martínez et al., 2019)	Evaluation of the five facets of mindfulness: observing, describing, acting consciously, not judging, internal experience and non-reactivity to internal experience, through 24 items.	Up to 3 months follow-up
Secondary	EuroQol (Brooks, 1996. Validated in Spanish by Badia et al., 1999)	Assessment of self-perceived health status.	Up to 3 months follow-up
Secondary	Short-format Therapeutic Alliance Inventory (WAI-S; Hatcher and Gillas, 2006. Validated in Spanish by Corbella et al., 2011)	Evaluation of the therapeutic alliance through 12 items.	Up to 3 months follow-up
Secondary	Maladjustment Scale (EI; Echeburua; 2000; Validated in Spanish by Quiléz-Orden et al., in press)	Evaluation through 6 items about the extent to which patients' psychological problems affect different areas of daily life: work or studies, social life, free time, couple relationship and family life.	Up to 3 months follow-up
Secondary	An adaptation of Client Satisfaction Questionnaire (CSQ-8) of Larsen et al., 1979	Our adaptation 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 more 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").	Up to 3 months follow-up
Secondary	Evaluation questionnaire of the PU modules (Ad hoc)	Questionnaire prepared ad hoc composed of 7 questions; one of a general nature that evaluates the usefulness of the program to improve emotional regulation and six specific ones that separately evaluate the usefulness to better regulate emotions of each of the techniques that are worked on in the different modules of the PU. The response scale is Likert-type and ranges from 0 (not at all) to 10 (very much).	Up to 3 months follow-up
Secondary	System Usability Scale (SUS; Brooke, 1996. Validated in Spanish by Sevilla-Gonzalez et al., 2020)	Scale used to evaluate the usability of the app included in PU condition in hybrid online group format	Up to 3 months follow-up

External Links

•   IPES web (Investigation group)