Depressive Disorder Clinical Trial
— PSICEOfficial 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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | January 30, 2024 |
Est. primary completion date | July 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 18 Years |
Eligibility | Inclusion Criteria: - 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). Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Spain | Universidad de la Rioja | Logroño | La Rioja |
Lead Sponsor | Collaborator |
---|---|
Eduardo Fonseca Pedrero | Consejo General de la Psicología de España, Psicofundación: Fundación Española para Promoción, Desarrollo Científico y Profesional de la Psicolo |
Spain,
Barlow 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. — View Citation
Barlow 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. — View Citation
de 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. — View Citation
Ehrenreich-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.
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. — View Citation
Sandín B, García-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). pii: E8306. doi: 10.3390/ijerph17228306. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline to 18 months after start of interventions | |
Primary | 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. | Baseline to 18 months after start of interventions | |
Secondary | 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. | Baseline to 18 months after start of interventions | |
Secondary | 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. | Baseline to 18 months after start of interventions | |
Secondary | 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. | Baseline to 18 months after start of interventions | |
Secondary | Transdiagnostic dimensions | Change in Multidimensional Emotional Disorders Inventory (MEDI) scores. Total score range from 0 to 392 Higher scores mean a worse outcome. | Baseline to 18 months after start of interventions | |
Secondary | Educational achievement outcome | Educational outcome measured by grades obtained by participant at school. Range from D to A. Higher scores mean a better outcome. | Baseline to 18 months after start of interventions |
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