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Active, not recruitingNCT05343741Updated Dec 5, 2025

Practice-Based Evidence in Psychotherapy in Ecuador

An observational study in Psychological Distress, sponsored by Universidad de las Americas - Quito. Active, not recruiting at 1 site in Ecuador. Open to participants aged 11 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-12-05.

Sponsored by Universidad de las Americas - Quito · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
340
Ages
11 Years to 100 Years
Sex
All
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Study 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

Read the 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.

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Conditions studied

  • Psychological Distress

Keywords

  • practice-based evidence
  • routine outcome monitoring
  • psychotherapy
  • change
  • outcome
  • psychological distress
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In context

Lead sponsor

Universidad de las Americas - Quito is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
11 Years to 100 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
340 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherPsychological Intervention

    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.

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What researchers measure

Primary outcomes

  1. 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).

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

  2. 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).

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

  3. 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.

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

Secondary outcomes

  1. Change in Life Satisfaction Scale

    It is a 10-point scale that asks respondents to rate their degree of satisfaction with life in the present. It will be presented in Spanish.

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

  2. Change in Ambivalence in Psychotherapy Questionnaire (APQ)

    It is a 9-item scale that measures the level of ambivalence towards change perceived by the consultants. It includes two subscales, demoralization and oscillation, and an overall score of ambivalence towards change (Oliveira et al., 2020). Both the original version (Oliveira et al., 2020) and the Spanish version (Montesano et al., submitted for publication) have demonstrated good psychometric properties, including good convergent and divergent validity. In this study the Spanish version will be used.

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

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

    It is a 15-item questionnaire with a scale of 1 to 5, where 1 means "strongly disagree" and 5 means "strongly agree". It was designed to be completed by family members, aged 12 years or older (Stratton et al., 2010). It has three dimensions: strengths, difficulties and communication. Lower scores correspond to better family functioning. In addition, the SCORE-15 has two scales ranging from 1 to 10 on which participants rate the perceived effectiveness of the therapeutic intervention and the perceived severity of the difficulty leading to treatment. In the present study, we will use the Spanish version of this measure which has shown adequate reliability and validity in a Spanish sample (Rivas \& Pereira, 2016).

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

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

    The CRES-4 scale has 4 items: one question on satisfaction, one on the level of resolution of the main problem, one on the emotional state before the start of treatment and one question on the emotional state when completing the questionnaire (Feixas et al., 2012). These questions allow interpretations to be made about the perceived change in their emotional state, satisfaction and resolution of the problem. In this study, the Spanish version of this measure will be used (Feixas et al., 2012).

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

  5. Change in Therapeutic Alliance Scale

    It is a 10-point one-item measure that evaluates therapeutic alliance. Clients are asked to state, in general, how connected they feel to their therapist and if they have talked about what the clients were interested in addressing in therapy. It will be presented in Spanish.

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

Other outcomes

  1. CORE Therapy Assessment Form (TAF)

    The CORE TAF is a pragmatic form designed to be filled out by therapists at baseline. The CORE-TAF includes referral information, sociodemographic data on the client, and data on the nature, severity, and duration of the client's problems. (Barkham et al., 2015; Evans 2003). We will use its Spanish version, which is currently being translated.

    Time frame: CORE TAF is completed at baseline

  2. CORE End of Therapy (EoT)

    The CORE EoT is a pragmatic form designed to be filled out by therapists immediately after treatment completion. The CORE-EoT reports on the completed treatment, including the number of sessions, type of therapy, length and frequency of sessions, whether the ending was planned or unplanned, and the potential benefits of therapy (Barkham et al., 2015; Evans 2003). We will use its Spanish version, which is currently being translated.

    Time frame: CORE EoT is completed immediately after treatment completion

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Study locations

1 site
  • Centro de Psicología Aplicada
    Quito, Pichincha, Ecuador
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References and documents

Publications

  • 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.
  • 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. PubMed 26641370 ↗
  • 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. PubMed 11772852 ↗
  • 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
  • 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. PubMed 29892966 ↗
  • 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.
  • 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.
  • 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. PubMed 32285558 ↗
  • 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. PubMed 32873334 ↗
  • 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.
  • 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.
  • 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. PubMed 27382288 ↗
  • 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.
  • 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. PubMed 37225267 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05343741
Lead sponsor
Universidad de las Americas - Quito
Responsible party
Jorge Valdiviezo Oña (Prof., Universidad de las Americas - Quito) — Principal investigator
First posted
Apr 25, 2022
Start date
Oct 17, 2022
Primary completion
Jul 20, 2025
Completion
Jun 2026 (estimated)
Last update
Dec 5, 2025

Study contacts

Jorge Valdiviezo-Oña, MSc
principal investigator · University of Americas
Clara Paz, PhD
study director · University of Americas
Adrián Montesano del Campo, PhD
study director · Universitat Oberta de Catalunya

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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