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Emotional DisordersPSIGTENCT07682064

Effectiveness of the Group Unified Protocol for Emotional Disorders in Adults in a Public Mental Health Setting

A study testing UP and TAU in people with Emotional Disorders and ANXIETY DISORDERS (or Anxiety and Phobic Neuroses), run by Patricia Fernández Couto at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study has three primary objectives: 1. To adapt the Spanish version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP; Barlow et al., 2011, 2019a, 2019b) for delivery in a group format within the Spanish Public Mental Health System for adults diagnosed with emotional disorders. 2. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
UP and TAU
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
1 siteSpain
Study dates
27 Apr 2024to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18 to 65 years.
  • Ability and willingness to provide written informed consent.
  • Sufficient proficiency in Spanish to participate in the intervention and complete study assessments.
  • Sufficient cognitive capacity to understand the intervention content.
  • A primary diagnosis of an emotional disorder with mild, moderate, or severe symptom severity, including Depressive Disorders, Anxiety Disorders, Obsessive-Compulsive and Related Disorders, Trauma and Stressor-Related Disorders, Dissociative Disorders and Somatic Symptom and Related Disorders.
  • Presence of emotional symptoms (e.g., anxiety, depressive, or phobic symptoms), somatic symptoms, obsessive symptoms, and/or avoidance behaviors associated with clinically significant impairment, as indicated by moderate or higher scores on the GAD-7, PHQ-9, and/or PHQ-15.

Who cannot join

  • Refusal to provide informed consent or withdrawal of consent during the study.
  • Current severe substance use disorder or behavioral addiction.
  • Current high suicide risk.
  • Current psychotic symptoms or psychotic disorder.
  • Neurological disorders or severe medical conditions that could interfere with participation in or adherence to the intervention.
  • Intellectual disability, significant language difficulties, or any other condition that may impair the participant's ability to understand the intervention content.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Patricia Fernández-Couto, Clinical Psychologist contact

(+34)941296251 ext. 80324

pafernco@unirioja.es

Spain1 site, 1 recruiting

  • Centro de Salud Espartero

    Logroño, La Rioja, 26007

    Patricia Fernández Couto, (+34)941296251 ext. 80324, pafernco@unirioja.es

    Recruiting

Other trials in Spain

About this study

Official title: Effectiveness of the Group Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP; Barlow et al. 2011, 2019a, 2019b) in Adults in a Public Mental Health Setting

This study has three primary objectives:

  1. To adapt the Spanish version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP; Barlow et al., 2011, 2019a, 2019b) for delivery in a group format within the Spanish Public Mental Health System for adults diagnosed with emotional disorders.
  2. To evaluate the effectiveness of the intervention.
  3. To assess its clinical feasibility and acceptability in routine clinical practice.
Read more

Outcomes will include anxiety, depression, somatic symptoms, transdiagnostic variables, functional impairment, quality of life, and participant satisfaction. These outcomes will be assessed at baseline, post-treatment, and 3-month follow-up.

The intervention is expected to improve emotional symptoms, functional impairment, and quality of life. In addition, the study will explore whether this group-based transdiagnostic approach may help lower demand on public mental health services.

Read the detailed description

Anxiety and depressive disorders are among the leading causes of disability and contributors to the global burden of disease worldwide. To address this public health challenge, stepped-care models have been developed to organize treatment according to patients' clinical needs and progression. Within this framework, the transdiagnostic approach proposes that emotional disorders share common underlying transdiagnostic mechanisms, including elevated negative affect and maladaptive emotion regulation strategies such as emotional avoidance.

Accordingly, the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) has emerged as an evidence-based intervention for anxiety, depressive, and related emotional disorders. The UP aims to enhance adaptive emotion regulation and lower maladaptive behavioral avoidance, thereby promoting improvements across a broad range of emotional symptoms.

This study aims to adapt and implement the Spanish version of the UP in a group format for adults diagnosed with an emotional disorder receiving treatment within the Spanish Public Mental Health System. In addition, the study will evaluate the intervention's effectiveness, feasibility, acceptability, and cost-effectiveness. The intervention will be delivered in Public Mental Health Units of the La Rioja Health Service.

Adults aged 18 to 65 years diagnosed with an emotional disorder will be recruited. The study will employ a randomized controlled trial design with two parallel groups: a Treatment as Usual (TAU) group and an experimental group (UP + TAU). Assessments will be conducted at pre-treatment, post-treatment, and 3-month follow-up. Outcome measures will assess anxiety, depression, somatic symptoms, transdiagnostic processes, functional impairment, quality of life, participant satisfaction, and intervention cost-effectiveness.

Being tested
UP, TAU
Keywords
Unified Protocol, emotional disorder, UP, treatment
Medical subject headings
Anxiety Disorders, Phobic Disorders, Depressive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UPBehavioural

    The UP includes eight modules designed to enhance emotion regulation skills: (1) Motivation Enhancement and Goal Setting; (2) Psychoeducation and Tracking Emotional Experiences; (3) Training in Present-Focused Emotional Awareness; (4) Cognitive Flexibility; (5) Countering Emotional Behaviors; (6) Understanding and Tolerating Physical Sensations; (7) Emotional Exposure; and (8) Recognizing Achievements and Maintaining Progress.

  • TAUBehavioural

    TAU in the Public Mental Health Units of the La Rioja Health Service consists of care provided by specialists in Clinical Psychology and/or Psychiatry in accordance with routine clinical practice.

Study groups in NCT07682064
Study groupRoleWhat they receive
3-month Unified Protocol + Treatment as UsualExperimentalThe UP (Barlow et al., 2011, 2019a, 2019b) is an emotion-focused, transdiagnostic cognitive-behavioral therapy for adults. Participants will receive a 9-session group-based adaptation of the UP, delivered in addition to treatment as usual (TAU). The program is designed for adults with emotional disorders receiving care within the Spanish Public Mental Health System.
Receives: Behavioral: UP
3-month Treatment as UsualActive comparatorParticipants assigned to the control group will receive treatment as usual (TAU) provided by the collaborating Public Mental Health Units. TAU will be delivered individually by the participant's assigned mental health professional and may include psychological and/or pharmacological treatment according to routine clinical practice.
Receives: Behavioral: TAU

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anxiety Symptoms

    Change in total score on the Generalized Anxiety Disorder-7 (GAD-7; Spitzer et al., 2006). The GAD-7 consists of seven items with total scores ranging from 0 to 21, where higher scores indicate greater anxiety symptom severity.

    Measured: Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.

  2. Depressive Symptoms

    Change in total score on the Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2001). The PHQ-9 includes nine items with total scores ranging from 0 to 27, where higher scores indicate greater depressive symptom severity.

    Measured: Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.

  3. Somatic Symptoms

    Change in total score on the Patient Health Questionnaire-15 (PHQ-15; Kroenke et al., 2010). The PHQ-15 consists of fifteen items with total scores ranging from 0 to 30, where higher scores indicate greater somatic symptom severity.

    Measured: Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.

Secondary outcomes (6)

  1. Experiential avoidance

    Change in total score on the Acceptance and Action Questionnaire-II (AAQ-II; Ruiz et al., 2013). The AAQ-II includes seven items with total scores ranging from 7 to 42, where higher scores reflect greater experiential avoidance.

    Measured: Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.

  2. Functional impairment

    Change in total score on the Inadaptation Scale (EI; Echeburúa et al., 2000). The EI consists of six items with total scores ranging from 0 to 30, where higher scores indicate greater functional impairment.

    Measured: Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.

  3. Perceived quality of life

    Change in total and domain scores on the WHO Quality of Life-BREF (WHOQOL-BREF; Lucas-Carrasco, 2012). The WHOQOL-BREF includes 26 items across multiple domains, with item scores ranging from 1 to 5. Higher scores indicate better perceived quality of life.

    Measured: Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.

  4. Transdiagnostic dimensions

    Change in scores across domains on the Multidimensional Emotional Disorder Inventory (MEDI; Rosellini \& Brown, 2019). The MEDI includes 49 items rated from 0 to 8, grouped into nine domains. Higher scores indicate greater severity of transdiagnostic emotional disorder dimensions.

    Measured: Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.

  5. Satisfaction with the program

    Participant satisfaction will be assessed post-intervention using a 10-item questionnaire adapted from García-Escalera et al. (2020). Each item is rated on a 5-point Likert scale ranging from 0 to 4. Total scores range from 0 to 40, with higher scores indicating greater satisfaction. Some items are reverse coded prior to score calculation.

    Measured: Immediately after completion of the 3-month intervention.

  6. Use of healthcare resources

    Composite measure of healthcare utilization, including number of visits to healthcare services, missed treatment sessions, and number of medical tests performed.

    Measured: Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2026
  2. Study start27 Apr 2024
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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
Parallel Assignment
Masking
None (open label)
Enrolment
106 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07682064
Sponsor's protocol ID
CEImLar P.I. 675
Other IDs
CEImLar P.I.675
Acronym
PSIGTE
Status last verified
Jun 2026
First submitted
24 Jun 2026
Last updated
2 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The study team does not plan to share de-identified individual participant data. Only aggregated data will be made available through scientific publications and conference presentations.

Publications

  • Barlow, D. H., Farchione, T. J., Sauer-Zavala, S., Murray, H., Ellard, K., Bullis, J., & Bentley, K. H. (2019). Protocolo Unificado para el Tratamiento Transdiagnóstico de los Trastornos Emocionales (2nd ed.): Manual del terapeuta. Alianza Editorial. https://doi.org/10.1093/med:psych/9780199772667.001.0001

  • Barlow, D. H., Sauer-Zavala, S., Farchione, T. J., Murray, H., Ellard, K., Bullis, J., & Cassiello-Robbins, C. (2019). Protocolo Unificado para el Tratamiento Transdiagnóstico de los Trastornos Emocionales (2nd ed.): Manual del paciente. Alianza Editorial. https://doi.org/10.1093/med:psych/9780199772667.001.0001

  • Osma, J., Castellano, C., Crespo, E., & García-Palacios, A. (2015). The unified protocol for transdiagnostic treatment of emotional disorders in group format in a Spanish public mental health setting. Behavioral Psychology, 23(3), 447-466.

  • Sakiris N, Berle D. A systematic review and meta-analysis of the Unified Protocol as a transdiagnostic emotion regulation based intervention. Clin Psychol Rev. 2019 Aug;72:101751. doi: 10.1016/j.cpr.2019.101751. Epub 2019 Jun 25.

    PubMed 31271848

  • Garcia-Escalera J, Valiente RM, Sandin B, Ehrenreich-May J, Prieto A, Chorot P. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) Adapted as a School-Based Anxiety and Depression Prevention Program: An Initial Cluster Randomized Wait-List-Controlled Trial. Behav Ther. 2020 May;51(3):461-473. doi: 10.1016/j.beth.2019.08.003. Epub 2019 Aug 14.

    PubMed 32402261

  • Cassiello-Robbins C, Southward MW, Tirpak JW, Sauer-Zavala S. A systematic review of Unified Protocol applications with adult populations: Facilitating widespread dissemination via adaptability. Clin Psychol Rev. 2020 Jun;78:101852. doi: 10.1016/j.cpr.2020.101852. Epub 2020 Apr 20.

    PubMed 32360953

  • Carlucci L, Saggino A, Balsamo M. On the efficacy of the unified protocol for transdiagnostic treatment of emotional disorders: A systematic review and meta-analysis. Clin Psychol Rev. 2021 Jul;87:101999. doi: 10.1016/j.cpr.2021.101999. Epub 2021 Mar 9.

    PubMed 34098412

  • Farchione TJ, Fairholme CP, Ellard KK, Boisseau CL, Thompson-Hollands J, Carl JR, Gallagher MW, Barlow DH. Unified protocol for transdiagnostic treatment of emotional disorders: a randomized controlled trial. Behav Ther. 2012 Sep;43(3):666-78. doi: 10.1016/j.beth.2012.01.001. Epub 2012 Jan 18.

    PubMed 22697453

  • Osma J, Peris-Baquero O, Suso-Ribera C, Farchione TJ, Barlow DH. Effectiveness of the Unified Protocol for transdiagnostic treatment of emotional disorders in group format in Spain: Results from a randomized controlled trial with 6-months follow-up. Psychother Res. 2022 Mar;32(3):329-342. doi: 10.1080/10503307.2021.1939190. Epub 2021 Jun 16.

    PubMed 34132170

  • Barlow, D. H., Farchione, T. J., Fairholme, C. P., Ellard, K. K., Boisseau, C. L., Allen, L. B., & Ehrenreich-May, J. (2011). The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders: Therapist Guide. Oxford University Press. https://doi.org/10.1093/med:psych/9780199772667.001.0001

Questions about this trial

What is this clinical trial studying?

A study testing UP and TAU in people with Emotional Disorders and ANXIETY DISORDERS (or Anxiety and Phobic Neuroses), run by Patricia Fernández Couto 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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 2 Jul 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Patricia Fernández-Couto, Clinical Psychologist ((+34)941296251 ext. 80324, pafernco@unirioja.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anxiety Symptoms (time frame: Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention.). The study lists 3 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 NCT07682064, which also lists 10 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 2 Jul 2026.

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