Clinical trial NCT06432829: Study on the Effectiveness and Differential Usability of the UP in Spanish University Students
Official title: Study on the Efficacy and Differential Usability of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Spanish University Students
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Emotional Disorder
Depression, Anxiety
Emotion Regulation
Keywords: Emotional Disorders
University Students
Unified Protocol
Blended format
Online interventions
Group formats
Lead sponsor: Instituto de Investigación Sanitaria Aragón
Sponsor class: OTHER
First posted: 2024-05-29
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be recruited through the Psychological Care Unit (UNAP) of the University of Cordoba (Spain). The UNAP will refer to the research team those persons whose reason for consultation refers to an emotional problem (anxious and/or depressive symptomatology). Potential participants will be contacted by the research team via email and will be sent an information sheet about the study and informed consent, which they will be able to read and sign online through a Google Forms link.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Structured interview for anxiety disorders and related disorders, according to the DSM-5 (ADIS-5; Brown & Barlow, 2014)
timeFrame: Only before of the treatment to check inclusion criteria
measure: Questionnaire on Sociodemographic Data (ad hoc)
timeFrame: Pre-treatment data
measure: General Depression Severity and Interference Scale (ODSIS; Bentley et al., 2014. Validated in Spanish by Osma et al., 2019)
timeFrame: Up to 3 months follow-up
measure: General Severity and Interference Scale for Anxiety (OASIS; Norman et al., 2006. Validated in Spanish by Osma et al., 2019)
timeFrame: Up to 3 months follow-up
measure: Multidimensional Inventory for Emotional Disorders (MEDI; Rosellini and Brown, 2019. Validated in Spanish by Osma et al., 2023)
timeFrame: Up to 3 months follow-up
Secondary outcomes:
measure: Emotional Regulation Difficulties Scale (DERS; Gratz and Roemer, 2004. Validated in Spanish by Hervás & Jódar, 2008)
timeFrame: Up to 3 months follow-up
measure: Emotional Regulation Questionnaire (ERQ; Gross & John, 2003. Validated in Spanish by Pineda et al., 2018)
timeFrame: Up to 3 months follow-up
measure: Short Version of the Five Facets of Mindfulness Questionnaire (FFMQ-SF; Bohlmeijer et al., 2011. Validated in Spanish by Asensio-Martínez et al., 2019)
timeFrame: Up to 3 months follow-up
measure: EuroQol (Brooks, 1996. Validated in Spanish by Badia et al., 1999)
timeFrame: Up to 3 months follow-up
measure: Short-format Therapeutic Alliance Inventory (WAI-S; Hatcher and Gillas, 2006. Validated in Spanish by Corbella et al., 2011)
timeFrame: Up to 3 months follow-up
measure: Maladjustment Scale (EI; Echeburua; 2000; Validated in Spanish by Quiléz-Orden et al., in press)
timeFrame: Up to 3 months follow-up
measure: An adaptation of Client Satisfaction Questionnaire (CSQ-8) of Larsen et al., 1979
timeFrame: Up to 3 months follow-up
measure: Evaluation questionnaire of the PU modules (Ad hoc)
timeFrame: Up to 3 months follow-up
measure: System Usability Scale (SUS; Brooke, 1996. Validated in Spanish by Sevilla-Gonzalez et al., 2020)
timeFrame: Up to 3 months follow-up
Other outcomes:
Locations:
city: Teruel
country: Spain
facility: Instituto de investigación sanitaria de Aragón, universidad de Zaragoza
Study officials:
References: