Emotional DisorderNCT06432829
Study on the Effectiveness and Differential Usability of the UP in Spanish University Students
A study testing Unified Protocol for the transdiagnostic treatment of emotional disorders in people with Emotional Disorder and Depression, Anxiety, run by Instituto de Investigación Sanitaria Aragón at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Emotional Disorder, Depression, Anxiety, Emotion Regulation
- What is being tested?
- Unified Protocol for the transdiagnostic treatment of emotional disorders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jun 2024to 15 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Spain1 site
Instituto de investigación sanitaria de Aragón, universidad de Zaragoza
Teruel, 44003
About this study
Official title: Study on the Efficacy and Differential Usability of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Spanish University Students
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.
Read the 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.
- Conditions
- Emotional Disorder, Depression, Anxiety, Emotion Regulation
- Being tested
- Unified Protocol for the transdiagnostic treatment of emotional disorders
- Keywords
- Emotional Disorders, University Students, Unified Protocol, Blended format, Online interventions, Group formats
- Medical subject headings
- Depression, Anxiety Disorders, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unified Protocol for the transdiagnostic treatment of emotional disordersBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Unified Protocol for the transdiagnostic treatment of emotional disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Evaluation through 28 items of difficulties in emotional regulation by means of 5 subscales: lack of control, rejection, interference, inattention and emotional confusion.
Measured: Up to 3 months follow-up
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.
Measured: 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)
Evaluation of the five facets of mindfulness: observing, describing, acting consciously, not judging, internal experience and non-reactivity to internal experience, through 24 items.
Measured: Up to 3 months follow-up
EuroQol (Brooks, 1996. Validated in Spanish by Badia et al., 1999)
Assessment of self-perceived health status.
Measured: 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)
Evaluation of the therapeutic alliance through 12 items.
Measured: Up to 3 months follow-up
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.
Measured: Up to 3 months follow-up
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").
Measured: Up to 3 months follow-up
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).
Measured: Up to 3 months follow-up
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
Measured: Up to 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start15 Jun 2024 (estimated)
- Primary completion15 Sep 2024 (estimated)
- Study completion15 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria Aragón
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge Javier Osma López, Instituto de Investigación Sanitaria Aragón
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06432829
- Sponsor's protocol ID
- IPES/PU-E/2024
- Status last verified
- May 2024
- First submitted
- 22 May 2024
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Under request
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Efficacy and Differential Usability of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Spanish University Students
- ClinicalTrials.gov ID
- NCT06432829
- Acronym / sponsor ID
- IPES/PU-E/2024
- Conditions
- Emotional Disorder, Depression, Anxiety, Emotion Regulation
- Keywords
- Emotional Disorders, University Students, Unified Protocol, Blended format, Online interventions, Group formats
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Instituto de Investigación Sanitaria AragónUniversity, hospital or other
- Study start
- 15 Jun 2024 (estimated)
- Primary completion
- 15 Sep 2024 (estimated)
- Study completion
- 15 Sep 2025 (estimated)
- First posted
- 29 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| UP in online group format | Active comparator | Behavioral: Unified Protocol for the transdiagnostic treatment of emotional disordersThe 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. |
| UP in blended format (UP online group + UP App) | Experimental | Behavioral: Unified Protocol for the transdiagnostic treatment of emotional disordersParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unified Protocol for the transdiagnostic treatment of emotional disordersThis 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. | Behavioural | UP in blended format (UP online group + UP App), UP in online group format |
Primary outcome
Structured interview for anxiety disorders and related disorders, according to the DSM-5 (ADIS-5; Brown & Barlow, 2014)
Time frame: Only before of the treatment to check inclusion criteria
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.
Questionnaire on Sociodemographic Data (ad hoc)
Time frame: Pre-treatment data
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.
General Depression Severity and Interference Scale (ODSIS; Bentley et al., 2014. Validated in Spanish by Osma et al., 2019)
Time frame: Up to 3 months follow-up
Evaluation through 5 items of the frequency, intensity, severity and interference of depressive symptomatology
General Severity and Interference Scale for Anxiety (OASIS; Norman et al., 2006. Validated in Spanish by Osma et al., 2019)
Time frame: Up to 3 months follow-up
Evaluation through 5 items of the frequency, intensity, severity and interference of anxious symptomatology
Multidimensional Inventory for Emotional Disorders (MEDI; Rosellini and Brown, 2019. Validated in Spanish by Osma et al., 2023)
Time frame: Up to 3 months follow-up
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
9 secondary outcomes
Emotional Regulation Difficulties Scale (DERS; Gratz and Roemer, 2004. Validated in Spanish by Hervás & Jódar, 2008)
Time frame: Up to 3 months follow-up
Emotional Regulation Questionnaire (ERQ; Gross & John, 2003. Validated in Spanish by Pineda et al., 2018)
Time frame: 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)
Time frame: Up to 3 months follow-up
EuroQol (Brooks, 1996. Validated in Spanish by Badia et al., 1999)
Time frame: 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)
Time frame: Up to 3 months follow-up
Maladjustment Scale (EI; Echeburua; 2000; Validated in Spanish by Quiléz-Orden et al., in press)
Time frame: Up to 3 months follow-up
An adaptation of Client Satisfaction Questionnaire (CSQ-8) of Larsen et al., 1979
Time frame: Up to 3 months follow-up
Evaluation questionnaire of the PU modules (Ad hoc)
Time frame: Up to 3 months follow-up
System Usability Scale (SUS; Brooke, 1996. Validated in Spanish by Sevilla-Gonzalez et al., 2020)
Time frame: Up to 3 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- IPES web (Investigation group)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Under request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unified Protocol for the transdiagnostic treatment of emotional disorders in people with Emotional Disorder and Depression, Anxiety, run by Instituto de Investigación Sanitaria Aragón at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jorge Osma, Ph. D. (978645390 ext. 34, osma@unizar.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Structured interview for anxiety disorders and related disorders, according to the DSM-5 (ADIS-5; Brown & Barlow, 2014) (time frame: Only before of the treatment to check inclusion criteria). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.