Practice-Based Evidence in Psychotherapy in Ecuador

November 28, 2025 updated by: Jorge Valdiviezo Oña, Universidad de las Americas - Quito

Practice-Based Evidence in Ecuador: Routine Outcome Monitoring in Psychotherapy for Common Mental Health Problems

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

Study Overview

Status

Active, not recruiting

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

340

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pichincha
      • Quito, Pichincha, Ecuador
        • Centro de Psicología Aplicada

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM)
Time Frame: CORE-OM is administered to adult clients at baseline and immediately after treatment completion
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)
Time Frame: CORE-10 is administered to adult clients at the second week and then routinely every week until treatment completion
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)
Time Frame: YP-CORE is administered to adolescent clients at baseline and then routinely every week until treatment completion
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Life Satisfaction Scale
Time Frame: Life Satisfaction Scale is administered to all clients at baseline and immediately after treatment completion
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.
Life Satisfaction Scale is administered to all clients at baseline and immediately after treatment completion
Change in Ambivalence in Psychotherapy Questionnaire (APQ)
Time Frame: APQ is administered to adult clients at baseline and then routinely every four weeks
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.
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)
Time Frame: SCORE-15 is administered to all clients at baseline, at four weeks and immediately after treatment completion
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).
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)
Time Frame: CRES-4 is administered to all clients immediately after treatment completion
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).
CRES-4 is administered to all clients immediately after treatment completion
Change in Therapeutic Alliance Scale
Time Frame: Therapeutic Alliance Scale is administered to all clients immediately after the first intervention and then routinely every week until treatment completion
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.
Therapeutic Alliance Scale is administered to all clients immediately after the first intervention and then routinely every week until treatment completion

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
CORE Therapy Assessment Form (TAF)
Time Frame: CORE TAF is completed at baseline
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.
CORE TAF is completed at baseline
CORE End of Therapy (EoT)
Time Frame: CORE EoT is completed immediately after treatment completion
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.
CORE EoT is completed immediately after treatment completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jorge Valdiviezo-Oña, MSc, University of Americas
  • Study Director: Clara Paz, PhD, University of Americas
  • Study Director: Adrián Montesano del Campo, PhD, Universitat Oberta de Catalunya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2022

Primary Completion (Actual)

July 20, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

March 31, 2022

First Submitted That Met QC Criteria

April 18, 2022

First Posted (Actual)

April 25, 2022

Study Record Updates

Last Update Posted (Actual)

December 5, 2025

Last Update Submitted That Met QC Criteria

November 28, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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