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

Instituto de Investigación Sanitaria Aragón

Status: Not yet enrolling

Conditions: Emotional Disorder; Depression, Anxiety; Emotion Regulation

Treatments: Behavioral: Unified Protocol for the transdiagnostic treatment of emotional disorders

Study type: Interventional

Funder types: Other

Identifiers

NCT06432829

IPES/PU-E/2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

UP in online group format

Active Comparator group

Description:

The participants assigned to this condition will receive the UP in group format through 8 sessions of 2 hours duration, once a week, in online format through the Google Meet platform. Participants will receive a brief manual with the important contents of each session, the exercises to be performed and the corresponding records.

Treatment:

Behavioral: Unified Protocol for the transdiagnostic treatment of emotional disorders

UP in blended format (UP online group + UP App)

Experimental group

Description:

Participants assigned to this condition will receive the PU in a blended group format (4 online group sessions, of two hours duration in modules 1,4,6 and 7 of the PU + autonomous work through the UP-APP). Thus, participants will receive a combined intervention format, working some contents in online group sessions and others through the PU-APP.

Treatment:

Behavioral: Unified Protocol for the transdiagnostic treatment of emotional disorders