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| ID | Type | Description | Link |
|---|---|---|---|
| CEImLar P.I.675 | Other Identifier | Research Ethics Committee for Medicines of La Rioja |
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| Name | Class |
|---|---|
| University of La Rioja | OTHER |
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This study has three primary objectives:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3-month Unified Protocol + Treatment as Usual | Experimental | The 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. |
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| 3-month Treatment as Usual | Active Comparator | Participants 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UP | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention. |
| 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. | Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention. |
| 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. | Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patricia Fernández-Couto, Clinical Psychologist | Contact | (+34)941296251 | 80324 | pafernco@unirioja.es |
| Name | Affiliation | Role |
|---|---|---|
| Patricia Fernández Couto, Clinical Psychologist | Servicio Riojano de Salud | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Salud Espartero | Recruiting | Logroño | La Rioja | 26007 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| Background | 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 | ||
| Background | 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. | ||
| 31271848 |
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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.
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Parallel Assignment
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| TAU | Behavioral | 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. |
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| 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. | Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention. |
| 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. | Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention. |
| 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. | Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention. |
| 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. | Immediately after completion of the 3-month intervention. |
| 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. | Baseline, at the end of the 3-month intervention, and 3 months after the end of the intervention. |
| Background |
| 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. |
| 32402261 | Background | 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. |
| 32360953 | Background | 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. |
| 34098412 | Background | 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. |
| 22697453 | Background | 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. |
| 34132170 | Background | 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. |
| Background | 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 |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D010698 | Phobic Disorders |
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D019964 | Mood Disorders |
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