NCT05343741

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
340

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Oct 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Oct 2022Jun 2026

First Submitted

Initial submission to the registry

March 31, 2022

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

October 17, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2025

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

December 5, 2025

Status Verified

November 1, 2025

Enrollment Period

2.8 years

First QC Date

March 31, 2022

Last Update Submit

November 28, 2025

Conditions

Keywords

practice-based evidenceroutine outcome monitoringpsychotherapychangeoutcomepsychological distress

Outcome Measures

Primary Outcomes (3)

  • Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM)

    The CORE-OM (Evans et al., 2002) is a 34-item self-report instrument designed for use in heterogeneous services and based on a pan-theoretic core of psychological distress, including subjective well-being, problems, risk, and functioning. Items are scored on a scale from 0 (never) to 4 (always or almost always). Higher scores indicate greater psychological distress. This instrument is suitable as an initial assessment tool and as an outcome measure. The Spanish versionof this measure will be used. This version was translated by Feixas et al. (2012) and has shown good psychometric properties in Spain (Trujillo et al. 2016) and Ecuador (Paz et al. 2020).

    CORE-OM is administered to adult clients at baseline and immediately after treatment completion

  • Change in Clinical Outcomes in Routine Evaluation-10 (CORE-10)

    The CORE-10 (Barkham et al., 2013) is a generic, short, and easy-to-use assessment measure. Its items were drawn from the CORE-OM. The CORE-10 is an instrument that has shown good psychometric properties (Barkham et al., 2013) and is practical for use on a session-by-session basis with people presenting with psychological distress in mental health settings. Its Spanish version will be used (Feixas et al., 2012).

    CORE-10 is administered to adult clients at the second week and then routinely every week until treatment completion

  • Change in Young Person's-Clinical Outcomes in Routine Evaluation (YP-CORE)

    The YP-CORE is a brief self-report instrument capable of detecting psychological distress in adolescents, generated by a wide range of problems, while providing information about the person's general functioning (Twigg et al., 2009). It has 10 items, which must be answered on a 5-point scale (0 to 4). Its Spanish version will be used. The YP-CORE was translated to Spanish by Feixas et al. (2018) and showed adequate psychometric properties. In the present study, we will use a version of this measure adapted for Ecuador and Latin America whose psychometric properties are being explored.

    YP-CORE is administered to adolescent clients at baseline and then routinely every week until treatment completion

Secondary Outcomes (5)

  • Change in Life Satisfaction Scale

    Life Satisfaction Scale is administered to all clients at baseline and immediately after treatment completion

  • Change in Ambivalence in Psychotherapy Questionnaire (APQ)

    APQ is administered to adult clients at baseline and then routinely every four weeks

  • Change in Systemic Clinical Outcome and Routine Evaluation-15 (SCORE-15)

    SCORE-15 is administered to all clients at baseline, at four weeks and immediately after treatment completion

  • Satisfaction with the Treatment Received Scale (CRES-4)

    CRES-4 is administered to all clients immediately after treatment completion

  • Change in Therapeutic Alliance Scale

    Therapeutic Alliance Scale is administered to all clients immediately after the first intervention and then routinely every week until treatment completion

Other Outcomes (2)

  • CORE Therapy Assessment Form (TAF)

    CORE TAF is completed at baseline

  • CORE End of Therapy (EoT)

    CORE EoT is completed immediately after treatment completion

Study Arms (1)

Helpseeking Ecuadorian adult and adolescent clients

The participants will be adolescent (11-17 years) and adult (\>18 years) clients presenting with common non-severe mental health problems who seek mental health services at the Centro de Psicología Aplicada. The CPA is an outpatient psychological service where students of the last semesters of the Clinical Psychology degree develop and practice their psychological care skills as co-therapists of professional clinical psychologists.

Other: Psychological Intervention

Interventions

The CPA provides outpatient psychological services to individuals: children, adolescents and adults, couples and families. At the CPA, care is carried out through the co-therapy model, which involves the participation of a professional clinical psychologist and a trainee. Psychotherapists with diverse theoretical and clinical backgrounds (mainly psychodynamic, cognitive, systemic and integrative), but a common constructivist approach, work in the center. The following elements are transversal in their practice: therapeutic alliance, healing environment, and a collaborative procedure between the client, the psychotherapist and the trainee co-therapist.

Helpseeking Ecuadorian adult and adolescent clients

Eligibility Criteria

Age11 Years - 100 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Helpseeking clients undergoing treatment at the Centro de Psicología Aplicada of the Universidad de Las Américas

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro de Psicología Aplicada

Quito, Pichincha, Ecuador

Location

Related Publications (14)

  • 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.

    BACKGROUND
  • 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.

    PMID: 26641370BACKGROUND
  • 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.

    PMID: 11772852BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 29892966BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 32285558BACKGROUND
  • 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.

    PMID: 32873334BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 27382288BACKGROUND
  • 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.

    BACKGROUND
  • Valdiviezo-Ona J, Montesano A, Evans C, Paz C. Fostering practice-based evidence through routine outcome monitoring in a university psychotherapy service for common mental health problems: a protocol for a naturalistic, observational study. BMJ Open. 2023 May 24;13(5):e071875. doi: 10.1136/bmjopen-2023-071875.

MeSH Terms

Interventions

Psychosocial Intervention

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Jorge Valdiviezo-Oña, MSc

    University of Americas

    PRINCIPAL INVESTIGATOR
  • Clara Paz, PhD

    University of Americas

    STUDY DIRECTOR
  • Adrián Montesano del Campo, PhD

    Universitat Oberta de Catalunya

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

March 31, 2022

First Posted

April 25, 2022

Study Start

October 17, 2022

Primary Completion

July 20, 2025

Study Completion (Estimated)

June 1, 2026

Last Updated

December 5, 2025

Record last verified: 2025-11

Locations