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

NCT06432829 | Not Yet Recruiting

• 1 other identifier: IPES/PU-E/2024
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Emotional Disorder; Depression, Anxiety; Emotion Regulation

Keywords

Emotional Disorders; University Students; Unified Protocol; Blended format; Online interventions; Group formats

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (9)

• Emotional Regulation Difficulties Scale (DERS; Gratz and Roemer, 2004. Validated in Spanish by Hervás & Jódar, 2008)

  Up to 3 months follow-up

• Emotional Regulation Questionnaire (ERQ; Gross & John, 2003. Validated in Spanish by Pineda et al., 2018)

  Up to 3 months follow-up

• Short Version of the Five Facets of Mindfulness Questionnaire (FFMQ-SF; Bohlmeijer et al., 2011. Validated in Spanish by Asensio-Martínez et al., 2019)

  Up to 3 months follow-up

• EuroQol (Brooks, 1996. Validated in Spanish by Badia et al., 1999)

  Up to 3 months follow-up

• Short-format Therapeutic Alliance Inventory (WAI-S; Hatcher and Gillas, 2006. Validated in Spanish by Corbella et al., 2011)

  Up to 3 months follow-up

Study Arms (2)

UP in online group format

ACTIVE COMPARATOR

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.

Behavioral: Unified Protocol for the transdiagnostic treatment of emotional disorders

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

EXPERIMENTAL

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.

Behavioral: Unified Protocol for the transdiagnostic treatment of emotional disorders

Interventions

Unified Protocol for the 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-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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Investigación Sanitaria Aragón: lead

Study Sites (1)

Instituto de investigación sanitaria de Aragón, universidad de Zaragoza

Teruel, 44003, Spain

Location

Related Links

• IPES web (Investigation group)

MeSH Terms

Conditions

Depression; Anxiety Disorders; Emotional Regulation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Self-Control; Social Behavior

Central Study Contacts

Jorge Osma, Ph. D.

CONTACT

978645390; osma@unizar.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are informed of the assigned intervention condition before the start of the intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: May 29, 2024
• Study Start: June 15, 2024
• Primary Completion: September 15, 2024
• Study Completion: September 15, 2025
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

ES (1)