Anxiety DisorderPSICENCT05322642
Efficacy of the Unified Protocol for the Transdiagnostic Treatment (UP-A; Ehrenreich-May et al., 2018) for Adolescents With Moderate Emotional Symptoms in Educational Settings
A study testing UPA in people with Anxiety Disorder and Depressive Disorder, run by Eduardo Fonseca Pedrero at 1 site in Spain.
Trial summary
The main goal is to assess the efficacy of the Unified Protocol for the Transdiagnostic Treatment (UP-A; Ehrenreich-May et al., 2018) for Adolescents with moderate emotional symptoms in educational settings The goal is to prevent emotional symptoms and improve the socio-emotional adjustment. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Anxiety Disorder, Depressive Disorder, Emotional Problem
- What is being tested?
- UPA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2021to 30 Jan 2024
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Be 12-18 years old
- Written informed consent from adolescent and legal guardian
- Being able to understand and read Spanish.
- Moderate depressive and anxiety symptoms according to the screening (score moderate level in the PHQ-9 and GAD-7).
Who cannot join
- Being diagnosed a mental disorder or alcohol and/or substance dependence disorder.
- The presence of high suicidal risk
- A medical disease or condition which prevent the participant from carry out the psychological treatment.
- Receiving another psychological treatment while the study is still ongoing.
- The increase and/or changes in the medication of participants receiving pharmacological treatment during the study
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universidad de la Rioja
Logroño, La Rioja, 26002
Eduardo Fonseca-Pedrero, phD, 349441299332, eduardo.fonseca@unirioja.es
About this study
Official title: Efficacy of the Unified Protocol for Transdiagnostic Treatment for Adolescents With Symptoms of Anxiety and Depression: a School-based Randomized Controlled Trial
The main goal is to assess the efficacy of the Unified Protocol for the Transdiagnostic Treatment (UP-A; Ehrenreich-May et al., 2018) for Adolescents with moderate emotional symptoms in educational settings The goal is to prevent emotional symptoms and improve the socio-emotional adjustment.
Read the detailed description
Emotional problems, such as anxiety and depression, are among the leading causes of associated disability and burden of disease worldwide among young people. Therefore, it is necessary to address this emerging social challenge through the implementation of prevention strategies in relevant stages of development such as adolescence. In recent years, a transdiagnosis approach to emotional disorders has been promoted, highlighting the unified protocol for transdiagnostic treatment of emotional disorders and symptoms in its different versions (adulthood, adolescence, and childhood). In this context, the main goal is to assess the efficacy of the Unified Protocol for the Transdiagnostic Treatment (UP-A; Ehrenreich-May et al., 2018) for Adolescents with moderate emotional symptoms in educational settings The goal is to prevent emotional symptoms and improve the socio-emotional adjustment. Adolescents aged 12-18 at high risk of for anxiety and depression disorders (cut-off scores 10-15 points, PHQ-9 and GAD-7) are selected. The design is a randomized controlled trial with two groups: active control (relaxation) and experimental (UP-A). Pre-test, post-test, and follow-up at 6, 12 and 18 months will be carried out. The impact of different behavioural, cognitive, affective, social, and academic functioning indicators is analyzed, as well as their effects in the short, medium, and long term. The satisfaction of the program by users (students, parents, and professionals) will also be evaluated. The implementation and validation of manualized and empirically validated psychological intervention programs, such as UP-A, should be a priority in educational and socio-health policies.
- Being tested
- UPA, Active control condition (Progressive Relaxation Training)
- Keywords
- adolescents, depression, anxiety, emotional problems, transdiagnostic, school, evidence-based
- Medical subject headings
- Anxiety Disorders, Depressive Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UPABehavioural
UP-A is divided into five main treatment modules and three optional modules. The UP-A seek to positively affect how adolescents with anxiety and/ or depression experiences, think about, and respond to a broad range of negative and positive emotions, rather than disorder-specific emotions (e.g., fear, sadness).
Active control condition (Progressive Relaxation Training)Behavioural
Progressive Relaxation Training (Bernstein and Borkovec) program is divided in ten sessions. Relaxation training often is used in behavior therapy as a means to reduce anxiety, tension, and stress. The goal is to release tension from your muscles, while helping you recognize what that tension feels like.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: (UP-A) | Experimental | The UP-A (Ehrenreich et al., 2008) is an emotion-focused, transdiagnostic CBT for adolescents A 10-session youth-focused programmed by adapting the core modules of UP-A, for indicated prevention and school settings. Receives: Behavioral: UPA |
| Active control condition | Active comparator | The active control condition will be based on the 10 session of Progressive Relaxation Training programme of Bernstein and Borkovec.
It follows a similar structure as the UP-A. A group format will be used. Receives: Behavioral: Active control condition (Progressive Relaxation Training) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression symptoms
Change in the Patient Health Questionnaire-9 (PHQ-9) total score. PHQ-9 total score for the nine items ranges from 0 to 27.Higher scores mean a worse outcome.
Measured: Baseline to 18 months after start of interventions
Anxiety symptoms
Change in the Generalised Anxiety Disorder Assessment (GAD-7) total score. GAD-7 total score for the seven items ranges from 0 to 21.Higher scores mean a worse outcome.
Measured: Baseline to 18 months after start of interventions
Secondary outcomes (5)
Emotional and behavioural problems
Change in the Strengths and Difficulties Questionnaire (SDQ) total score. Total dificulties score range from 0 to 40. Higher scores mean a worse outcome.
Measured: Baseline to 18 months after start of interventions
Health-related quality of life
Change in the Kidscreeen-10 (Health-related quality of life) total score. Total score range from 10 to 50. Higher scores mean a better outcome.
Measured: Baseline to 18 months after start of interventions
Positive and Negative Affect
Change in the Positive and Negative Affect Schedule-Brief child (PANAS-Child brief version) scores. Total scores range (both positive and negative Affect) from 5 to 25. For Positive Affect dimension Higher scores mean a better outcome. For Negative Affect dimension higher scores mean a worse outcome.
Measured: Baseline to 18 months after start of interventions
Transdiagnostic dimensions
Change in Multidimensional Emotional Disorders Inventory (MEDI) scores. Total score range from 0 to 392 Higher scores mean a worse outcome.
Measured: Baseline to 18 months after start of interventions
Educational achievement outcome
Educational outcome measured by grades obtained by participant at school. Range from D to A. Higher scores mean a better outcome.
Measured: Baseline to 18 months after start of interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start1 Dec 2021
- Primary completion1 Jul 2022 (estimated)
- Study completion30 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Anxiety 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eduardo Fonseca Pedrero
- Sponsor type
- University, hospital or other
- Collaborators
- Psicofundación: Fundación Española para Promoción, Desarrollo Científico y Profesional de la Psicolo, Consejo General de la Psicología de España
- Responsible party
- Sponsor-investigator, Eduardo Fonseca Pedrero, University of La Rioja
- Investigators
- Eduardo Fonseca Pedrero, PhD, Principal investigator, University of La Rioja
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05322642
- Sponsor's protocol ID
- Universidad de La Rioja
- Acronym
- PSICE
- Status last verified
- Apr 2022
- First submitted
- 15 Mar 2022
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Essau CA, Sasagawa S, Jones G, Fernandes B, Ollendick TH. Evaluating the real-world effectiveness of a cognitive behavior therapy-based transdiagnostic program for emotional problems in children in a regular school setting. J Affect Disord. 2019 Jun 15;253:357-365. doi: 10.1016/j.jad.2019.04.036. Epub 2019 Apr 16.
PubMed 31078836de la Torre-Luque A, Fiol-Veny A, Essau CA, Balle M, Bornas X. Effects of a transdiagnostic cognitive behaviour therapy-based programme on the natural course of anxiety symptoms in adolescence. J Affect Disord. 2020 Mar 1;264:474-482. doi: 10.1016/j.jad.2019.11.078. Epub 2019 Nov 14.
PubMed 32056776Sandin B, Garcia-Escalera J, Valiente RM, Espinosa V, Chorot P. Clinical Utility of an Internet-Delivered Version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (iUP-A): A Pilot Open Trial. Int J Environ Res Public Health. 2020 Nov 10;17(22):8306. doi: 10.3390/ijerph17228306.
PubMed 33182711Barlow DH, Harris BA, Eustis EH, Farchione TJ. The unified protocol for transdiagnostic treatment of emotional disorders. World Psychiatry. 2020 Jun;19(2):245-246. doi: 10.1002/wps.20748. No abstract available.
PubMed 32394551Barlow DH, Farchione TJ, Bullis JR, Gallagher MW, Murray-Latin H, Sauer-Zavala S, Bentley KH, Thompson-Hollands J, Conklin LR, Boswell JF, Ametaj A, Carl JR, Boettcher HT, Cassiello-Robbins C. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders Compared With Diagnosis-Specific Protocols for Anxiety Disorders: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Sep 1;74(9):875-884. doi: 10.1001/jamapsychiatry.2017.2164.
PubMed 28768327Ehrenreich-May J., Kennedy S.M., Sherman J.A., Bilek E.L., Buzzella B.A., Bennett S.M., Barlow D.H. Unified Protocols for Transdiagnostic Treatment of Emotional Disorders in Children and AdolescentsTherapist Guide: Therapist Guide. Oxford University Press; New York, NY, USA: 2017.
Fonseca-Pedrero E, Perez-Esteban A, Diez-Gomez A, Perez-Albeniz A, Al-Halabi S, Lucas-Molina B, Debbane M. A multicenter randomized controlled effectiveness trial of transdiagnostic treatment for adolescents with subthreshold anxiety and depressive symptoms. Psychol Med. 2026 Sep 4;56:e264. doi: 10.1017/S0033291726105443.
PubMed 42695201Fonseca-Pedrero E, Diez-Gomez A, Perez-Albeniz A, Al-Halabi S, Lucas-Molina B, Debbane M. Youth screening depression: Validation of the Patient Health Questionnaire-9 (PHQ-9) in a representative sample of adolescents. Psychiatry Res. 2023 Oct;328:115486. doi: 10.1016/j.psychres.2023.115486. Epub 2023 Sep 16.
PubMed 37738682
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Unified Protocol for Transdiagnostic Treatment for Adolescents With Symptoms of Anxiety and Depression: a School-based Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05322642
- Acronym / sponsor ID
- PSICE / Universidad de La Rioja
- Keywords
- adolescents, depression, anxiety, emotional problems, transdiagnostic, school, evidence-based
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Eduardo Fonseca PedreroUniversity, hospital or other
- Collaborators
- Psicofundación: Fundación Española para Promoción, Desarrollo Científico y Profesional de la Psicolo, Consejo General de la Psicología de España
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 12 Apr 2022 (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 main goal is to assess the efficacy of the Unified Protocol for the Transdiagnostic Treatment (UP-A; Ehrenreich-May et al., 2018) for Adolescents with moderate emotional symptoms in educational settings The goal is to prevent emotional symptoms and improve the socio-emotional adjustment.
Detailed description
Emotional problems, such as anxiety and depression, are among the leading causes of associated disability and burden of disease worldwide among young people. Therefore, it is necessary to address this emerging social challenge through the implementation of prevention strategies in relevant stages of development such as adolescence. In recent years, a transdiagnosis approach to emotional disorders has been promoted, highlighting the unified protocol for transdiagnostic treatment of emotional disorders and symptoms in its different versions (adulthood, adolescence, and childhood). In this context, the main goal is to assess the efficacy of the Unified Protocol for the Transdiagnostic Treatment (UP-A; Ehrenreich-May et al., 2018) for Adolescents with moderate emotional symptoms in educational settings The goal is to prevent emotional symptoms and improve the socio-emotional adjustment. Adolescents aged 12-18 at high risk of for anxiety and depression disorders (cut-off scores 10-15 points, PHQ-9 and GAD-7) are selected. The design is a randomized controlled trial with two groups: active control (relaxation) and experimental (UP-A). Pre-test, post-test, and follow-up at 6, 12 and 18 months will be carried out. The impact of different behavioural, cognitive, affective, social, and academic functioning indicators is analyzed, as well as their effects in the short, medium, and long term. The satisfaction of the program by users (students, parents, and professionals) will also be evaluated. The implementation and validation of manualized and empirically validated psychological intervention programs, such as UP-A, should be a priority in educational and socio-health policies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: (UP-A) | Experimental | Behavioral: UPAThe UP-A (Ehrenreich et al., 2008) is an emotion-focused, transdiagnostic CBT for adolescents A 10-session youth-focused programmed by adapting the core modules of UP-A, for indicated prevention and school settings. |
| Active control condition | Active comparator | Behavioral: Active control condition (Progressive Relaxation Training)The active control condition will be based on the 10 session of Progressive Relaxation Training programme of Bernstein and Borkovec. It follows a similar structure as the UP-A. A group format will be used. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Be 12-18 years old
- Written informed consent from adolescent and legal guardian
- Being able to understand and read Spanish.
- Moderate depressive and anxiety symptoms according to the screening (score moderate level in the PHQ-9 and GAD-7).
Key exclusion criteria (5 listed)
- Being diagnosed a mental disorder or alcohol and/or substance dependence disorder.
- The presence of high suicidal risk
- A medical disease or condition which prevent the participant from carry out the psychological treatment.
- Receiving another psychological treatment while the study is still ongoing.
- The increase and/or changes in the medication of participants receiving pharmacological treatment during the study
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 |
|---|---|---|
| UPAUP-A is divided into five main treatment modules and three optional modules. The UP-A seek to positively affect how adolescents with anxiety and/ or depression experiences, think about, and respond to a broad range of negative and positive emotions, rather than disorder-specific emotions (e.g., fear, sadness). | Behavioural | Experimental: (UP-A) |
| Active control condition (Progressive Relaxation Training)Progressive Relaxation Training (Bernstein and Borkovec) program is divided in ten sessions. Relaxation training often is used in behavior therapy as a means to reduce anxiety, tension, and stress. The goal is to release tension from your muscles, while helping you recognize what that tension feels like. | Behavioural | Active control condition |
Primary outcome
Depression symptoms
Time frame: Baseline to 18 months after start of interventions
Change in the Patient Health Questionnaire-9 (PHQ-9) total score. PHQ-9 total score for the nine items ranges from 0 to 27.Higher scores mean a worse outcome.
Anxiety symptoms
Time frame: Baseline to 18 months after start of interventions
Change in the Generalised Anxiety Disorder Assessment (GAD-7) total score. GAD-7 total score for the seven items ranges from 0 to 21.Higher scores mean a worse outcome.
5 secondary outcomes
Emotional and behavioural problems
Time frame: Baseline to 18 months after start of interventions
Health-related quality of life
Time frame: Baseline to 18 months after start of interventions
Positive and Negative Affect
Time frame: Baseline to 18 months after start of interventions
Transdiagnostic dimensions
Time frame: Baseline to 18 months after start of interventions
Educational achievement outcome
Time frame: Baseline to 18 months after start of interventions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Background: PubMed 31078836Essau CA, Sasagawa S, Jones G, Fernandes B, Ollendick TH. Evaluating the real-world effectiveness of a cognitive behavior therapy-based transdiagnostic program for emotional problems in children in a regular school setting. J Affect Disord. 2019 Jun 15;253:357-365. doi: 10.1016/j.jad.2019.04.036. Epub 2019 Apr 16.
- Background: PubMed 32056776de la Torre-Luque A, Fiol-Veny A, Essau CA, Balle M, Bornas X. Effects of a transdiagnostic cognitive behaviour therapy-based programme on the natural course of anxiety symptoms in adolescence. J Affect Disord. 2020 Mar 1;264:474-482. doi: 10.1016/j.jad.2019.11.078. Epub 2019 Nov 14.
- Background: PubMed 33182711Sandin B, Garcia-Escalera J, Valiente RM, Espinosa V, Chorot P. Clinical Utility of an Internet-Delivered Version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (iUP-A): A Pilot Open Trial. Int J Environ Res Public Health. 2020 Nov 10;17(22):8306. doi: 10.3390/ijerph17228306.
- Background: PubMed 32394551Barlow DH, Harris BA, Eustis EH, Farchione TJ. The unified protocol for transdiagnostic treatment of emotional disorders. World Psychiatry. 2020 Jun;19(2):245-246. doi: 10.1002/wps.20748. No abstract available.
- Background: PubMed 28768327Barlow DH, Farchione TJ, Bullis JR, Gallagher MW, Murray-Latin H, Sauer-Zavala S, Bentley KH, Thompson-Hollands J, Conklin LR, Boswell JF, Ametaj A, Carl JR, Boettcher HT, Cassiello-Robbins C. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders Compared With Diagnosis-Specific Protocols for Anxiety Disorders: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Sep 1;74(9):875-884. doi: 10.1001/jamapsychiatry.2017.2164.
- BackgroundEhrenreich-May J., Kennedy S.M., Sherman J.A., Bilek E.L., Buzzella B.A., Bennett S.M., Barlow D.H. Unified Protocols for Transdiagnostic Treatment of Emotional Disorders in Children and AdolescentsTherapist Guide: Therapist Guide. Oxford University Press; New York, NY, USA: 2017.
- Derived from this study: PubMed 42695201Fonseca-Pedrero E, Perez-Esteban A, Diez-Gomez A, Perez-Albeniz A, Al-Halabi S, Lucas-Molina B, Debbane M. A multicenter randomized controlled effectiveness trial of transdiagnostic treatment for adolescents with subthreshold anxiety and depressive symptoms. Psychol Med. 2026 Sep 4;56:e264. doi: 10.1017/S0033291726105443.
- Derived from this study: PubMed 37738682Fonseca-Pedrero E, Diez-Gomez A, Perez-Albeniz A, Al-Halabi S, Lucas-Molina B, Debbane M. Youth screening depression: Validation of the Patient Health Questionnaire-9 (PHQ-9) in a representative sample of adolescents. Psychiatry Res. 2023 Oct;328:115486. doi: 10.1016/j.psychres.2023.115486. Epub 2023 Sep 16.
- Individual participant dataSharing planned: Undecided
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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.
Eduardo Fonseca Pedrero, PhD principal investigator
University of La Rioja
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UPA in people with Anxiety Disorder and Depressive Disorder, run by Eduardo Fonseca Pedrero 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 4 inclusion and 5 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 13 Apr 2022. 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 Eduardo Fonseca-Pedrero, PHD (941293222 ext. 9332, eduardo.fonseca@unirioja.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression symptoms (time frame: Baseline to 18 months after start of interventions). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05322642, which also lists 8 linked publications.
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 13 Apr 2022.