Clinical trial NCT05343741: Practice-Based Evidence in Psychotherapy in Ecuador
Official title: Practice-Based Evidence in Ecuador: Routine Outcome Monitoring in Psychotherapy for Common Mental Health Problems
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Psychological Distress
Keywords: practice-based evidence
routine outcome monitoring
psychotherapy
change
outcome
psychological distress
Lead sponsor: Universidad de las Americas - Quito
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 340
Sex: ALL
Minimum age (years): 11
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Helpseeking clients undergoing treatment at the Centro de Psicología Aplicada of the Universidad de Las Américas

Brief summary: This is a naturalistic study implementing a routine outcome monitoring system to track clients' change and outcomes at the Centro de Psicología Aplicada (CPA) of the Universidad de Las Américas in Quito, Ecuador

Detailed description: This is an exploratory and descriptive naturalistic longitudinal project. The general objective of this study is to systematically examine the progress and outcomes of psychological interventions provided at the Centro de Psicología Aplicada (CPA) of the Universidad de Las Américas by routinely monitoring outcomes through an standardized system.

Characteristics of the participants and the received interventions will be recorded through the use of assessment forms filled by therapists before and after therapy, and clients will complete outcome measures on psychological distress, life satisfaction, ambivalence in psychotherapy, family functioning, therapeutic alliance, and satisfaction with the treatment received.

This is the first project in Ecuador to propose a system for routine outcome monitoring in psychotherapy. It could contribute to develop normative trajectories of change and expected recovery curves in the future and to improve the quality of psychological treatments.

Eligibility criteria: Inclusion Criteria:

* Be 11 years of age or older.
* Have sufficient ability to communicate in Spanish.
* Undergo psychological treatment at the CPA.

Exclusion Criteria:

* Present substantial cognitive deficits that do not allow the development of the evaluation.

Primary outcomes:
measure: Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM)
timeFrame: CORE-OM is administered to adult clients at baseline and immediately after treatment completion
measure: Change in Clinical Outcomes in Routine Evaluation-10 (CORE-10)
timeFrame: CORE-10 is administered to adult clients at the second week and then routinely every week until treatment completion
measure: Change in Young Person's-Clinical Outcomes in Routine Evaluation (YP-CORE)
timeFrame: YP-CORE is administered to adolescent clients at baseline and then routinely every week until treatment completion
Secondary outcomes:
measure: Change in Life Satisfaction Scale
timeFrame: Life Satisfaction Scale is administered to all clients at baseline and immediately after treatment completion
measure: Change in Ambivalence in Psychotherapy Questionnaire (APQ)
timeFrame: APQ is administered to adult clients at baseline and then routinely every four weeks
measure: Change in Systemic Clinical Outcome and Routine Evaluation-15 (SCORE-15)
timeFrame: SCORE-15 is administered to all clients at baseline, at four weeks and immediately after treatment completion
measure: Satisfaction with the Treatment Received Scale (CRES-4)
timeFrame: CRES-4 is administered to all clients immediately after treatment completion
measure: Change in Therapeutic Alliance Scale
timeFrame: Therapeutic Alliance Scale is administered to all clients immediately after the first intervention and then routinely every week until treatment completion
Other outcomes:
measure: CORE Therapy Assessment Form (TAF)
timeFrame: CORE TAF is completed at baseline
measure: CORE End of Therapy (EoT)
timeFrame: CORE EoT is completed immediately after treatment completion
Locations:
city: Quito
country: Ecuador
facility: Centro de Psicología Aplicada
state: Pichincha
Study officials:
affiliation: University of Americas
name: Jorge Valdiviezo-Oña, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Americas
name: Clara Paz, PhD
role: STUDY_DIRECTOR
affiliation: Universitat Oberta de Catalunya
name: Adrián Montesano del Campo, PhD
role: STUDY_DIRECTOR
References:
citation: Barkham M, Bewick B, Mullin T, Gilbody S, Connell J, Cahill J, Mellor-Clark J, Richards D, Unsworth G, Evans C. The CORE-10: A short measure of psychological distress for routine use in the psychological therapies. Counselling and Psychotherapy Research. 2013; 13(1): 3-13.
citation: Barkham M, Mellor-Clark J, Stiles WB. A CORE approach to progress monitoring and feedback: Enhancing evidence and improving practice. Psychotherapy (Chic). 2015 Dec;52(4):402-11. doi: 10.1037/pst0000030.
citation: Evans C, Connell J, Barkham M, Margison F, McGrath G, Mellor-Clark J, Audin K. Towards a standardised brief outcome measure: psychometric properties and utility of the CORE-OM. Br J Psychiatry. 2002 Jan;180:51-60. doi: 10.1192/bjp.180.1.51.
citation: Evans C, Connell J, Barkham M, Marshall C, Mellor-Clark J. Practice-based evidence: benchmarking NHS primary care counselling services at national and local levels. Clinical Psychology & Psychotherapy: An International Journal of Theory & Practice. 2003; 10(6): 374-388
citation: Feixas G, Badia E, Bados A, Medina JC, Grau A, Magallon E, Botella L, Evans C. Adaptation and psychometric properties of the spanish version of the yp-core (Young Person's Clinical Outcomes in Routine Evaluation). Actas Esp Psiquiatr. 2018 May;46(3):75-82. Epub 2018 May 1.
citation: Feixas G, Evans C, Trujillo A, Saúl LÁ, Botella L, Corbella S, González S, Bados A, Garcia-Grau A, López-González. M. La version española del CORE-OM: Clinical Outcomes in Routine Evaluation - Outcome Measure. Revista de Psicoterapia. 2012; 23(89): 109-135.
citation: Feixas, G, Pucurull O, Roca C, Paz C, García-Grau E, Bados, A. Escala de satisfacción con el tratamiento recibido (CRES-4): la versión en español. Revista de Psicoterapia. 2012; 23(89): 51-58.
citation: Oliveira JT, Ribeiro AP, Goncalves MM. Ambivalence in Psychotherapy Questionnaire: Development and validation studies. Clin Psychol Psychother. 2020 Sep;27(5):727-735. doi: 10.1002/cpp.2457. Epub 2020 Apr 27.
citation: Paz C, Mascialino G, Evans C. Exploration of the psychometric properties of the Clinical Outcomes in Routine Evaluation-Outcome Measure in Ecuador. BMC Psychol. 2020 Sep 1;8(1):94. doi: 10.1186/s40359-020-00443-z.
citation: Rivas G, Pereira R. Validación de una escala de evaluación familiar: adaptación del SCORE-15 con normas en español. Mosaico: revista de la Federación Española de Asociaciones de Terapia Familiar. 2016; 63: 16-28.
citation: Stratton P, Bland J, Janes E, Lask J. Developing an indicator of family function and a practicable outcome measure for systemic family and couple therapy: the SCORE. Journal of family therapy. 2010; 32(3): 232-258.
citation: Trujillo A, Feixas G, Bados A, Garcia-Grau E, Salla M, Medina JC, Montesano A, Soriano J, Medeiros-Ferreira L, Canete J, Corbella S, Grau A, Lana F, Evans C. Psychometric properties of the Spanish version of the Clinical Outcomes in Routine Evaluation - Outcome Measure. Neuropsychiatr Dis Treat. 2016 Jun 21;12:1457-66. doi: 10.2147/NDT.S103079. eCollection 2016.
citation: Twigg E, Barkham M, Bewick BM, Mulhern B, Connell J, Cooper M. The YP-CORE: Development and validation of a young person's version of the CORE-OM. Counselling and Psychotherapy Research. 2009; 9: 160-168.