Practice-Based Evidence in Psychotherapy: A Multicentric Study From Ecuador (CLIP_Ecuador)

November 25, 2025 updated by: Clara Paz, Universidad de las Americas - Quito

Practice-Based Evidence in Ecuador: Routine Monitoring of Outcomes and Change in Psychotherapy for Common Mental Health Problems

The goal of this observational study is to learn about the progress and outcomes of clients receiving psychotherapy for common mental health problems in Ecuador. The main questions it aims to answer are:

  • How much do clients' psychological distress typically change during the course of their psychotherapy?
  • What factors are associated with outcomes in real-world mental health services in Ecuador?

This study involves clients who are about to start psychotherapy at one of the participating mental health clinics in Ecuador. Participants will continue their regular psychotherapy sessions as usual. The only addition is that before their sessions, they will be asked to complete questionnaires about their general well-being. This routine check-in process will continue throughout their time in therapy. Contextual information will be collected before starting treatment, and satisfaction with the treatment and any contextual changes will be collected after treatment ends.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This project is an exploratory, descriptive, and longitudinal naturalistic study. Its primary objective is to systematically examine client progress and treatment outcomes across a network of psychological care services in Ecuador by implementing a Routine Outcome Monitoring system. As a naturalistic investigation, the study will be conducted within existing clinical settings, ensuring that findings reflect real-world therapeutic practices with adolescent and adult populations.

The research will be implemented across multiple psychological care centers throughout Ecuador. To provide a comprehensive understanding of therapeutic processes, data will be collected at three distinct levels. At the client level, psychological distress serves as the primary outcome variable, supplemented by sociodemographic information collected at pre-treatment and post-treatment intervals and treatment satisfaction measures at post-treatment. At the therapist level, clinicians will complete client intake forms at treatment initiation and personal style questionnaires at treatment conclusion. Additionally, service-level data will be gathered from each participating center to characterize operational contexts and organizational frameworks.

The anticipated outcomes of this initiative are substantial. It will establish systematic tracking of client progress throughout therapy, enabling identification of population-specific levels of psychological distress and change trajectories. Furthermore, the project aims to create a foundational framework for the widespread implementation of outcome measurement systems in Ecuador's mental health care context.

In the long term, this project seeks to promote the consistent and generalized adoption of Routine Outcome Monitoring systems, thereby contributing to the development of a Practice-Based Evidence culture in Ecuador and throughout Latin America. It will strengthen Practice-Based Research Networks in psychological interventions, particularly through collaboration with established organizations such as the Consorcio Latinoamericano de Investigación en Psicoterapia (CLIP), fostering regional cooperation and standardizing assessment methodologies across mental health services.

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 Contact

Study Contact Backup

Study Locations

  • Ecuador
    • (P)Pichincha
      • Quito, (P)Pichincha, Ecuador, EC170503
        • Recruiting
        • Centro de Psicología Aplicada, Universidad de Las Américas, Ecuador
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jorge Valdiviezo-Oña, MSc
    • Manabí
      • Manta, Manabí, Ecuador, EC130203
        • Recruiting
        • Jorge López Consultorios
        • Contact:
        • Principal Investigator:
          • Itaty Benálcazar-Betancourt, MSc
      • Manta, Manabí, Ecuador
        • Recruiting
        • PsicoNeuro Manta
        • Principal Investigator:
          • Itaty Benálcazar-Betancourt, MSc
        • Contact:
    • Pichincha
      • Quito, Pichincha, Ecuador, EC100450
        • Recruiting
        • Historie
        • Principal Investigator:
          • Itaty Benálcazar-Betancourt, MSc
        • Contact:
      • Quito, Pichincha, Ecuador, EC170102
        • Recruiting
        • Kumpana
        • Principal Investigator:
          • Itaty Benálcazar-Betancourt, MSc
        • Contact:
      • Quito, Pichincha, Ecuador, EC170506
        • Recruiting
        • Mentis Psicología
        • Principal Investigator:
          • Itaty Benálcazar-Betancourt, MSc
        • Contact:
      • Quito, Pichincha, Ecuador, EC170517
        • Not yet recruiting
        • Equimente
        • Principal Investigator:
          • Itaty Benálcazar-Betancourt, MSc
        • Contact:
      • Quito, Pichincha, Ecuador, EC170517
        • Recruiting
        • Sentir Psicología Integral
        • Principal Investigator:
          • Itaty Benálcazar-Betancourt, MSc
        • Contact:
      • Quito, Pichincha, Ecuador, EC170523
        • Recruiting
        • Solo Psique
        • Principal Investigator:
          • Itaty Benálcazar-Betancourt, MSc
        • Contact:
      • Quito, Pichincha, Ecuador, EC17103
        • Recruiting
        • Renova - Mentis Habitus Positive
        • Principal Investigator:
          • Itaty Benálcazar-Betancourt, MSc
        • Contact:
      • Quito, Pichincha, Ecuador, EC17503
        • Recruiting
        • Psico Estratégico
        • Principal Investigator:
          • Itaty Benálcazar-Betancourt, MSc
        • Contact:

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The participant pool will consist of three groups: (1) help-seeking clients engaged in treatment, (2) therapists providing services, and (3) supervisors from the project's affiliated mental health services in Ecuador.

Description

Clients

Inclusion Criteria:

  • Be 11 years of age or older.
  • Have sufficient ability to communicate in Spanish.
  • Undergo psychological treatment at one of the mental health services included in the project.

Exclusion Criteria:

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

Therapists

Inclusion Criteria:

  • Therapist providing psychological treatment at one of the mental health services included in the project.

Supervisors

Inclusion Criteria:

  • Provide clinical supervision to therapists delivering treatment at any of the project's affiliated mental health services.

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 consist of adolescent (ages 11-17) and adult (ages 18 and above) clients who present with common, non-severe mental health problems and are seeking services at the participating clinics involved in this study.
Behavioral: Psychological Intervention
Real-world application of psychological care, adapted to the individual needs of clients within the normal workflow of clinical practice. Treatments are delivered by licensed practitioners in routine clinical settings, ensuring that interventions are tailored to each client's specific characteristics and therapeutic goals.

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: At baseline and immediately after treatment completion
The CORE-OM is a 34-item self-report instrument designed for use across heterogeneous services and grounded in 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 version of this measure will be used. This version was translated in Spain and has shown good psychometric properties in Spain and Ecuador. 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: From the second treatment session through treatment completion (an average of 10 weeks)
The CORE-10 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 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. In Ecuador, this version has shown good psychometric properties. CORE-10 is administered to adult clients.
From the second treatment session through treatment completion (an average of 10 weeks)
Change in Young Person's-Clinical Outcomes in Routine Evaluation (YP-CORE)
Time Frame: From baseline through treatment completion (an average of 10 weeks)
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. 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 into Spanish and showed adequate psychometric properties. In the present study, we will use a version of this measure, adapted for Ecuador and Latin America, which has good psychometric properties in Ecuador. YP-CORE is administered to adolescents.
From baseline through treatment completion (an average of 10 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emotional and Psychological Outcome (EPO-1)
Time Frame: From Baseline through treatment completion (an average of 10 weeks)
The EPO-1 is a single-item outcome measure in which clients assess their current emotional and psychological state by responding to the question: "At this moment, how are you doing emotionally and psychologically?" This item is scored on a 5-point scale ranging from 0 ("Very bad; I can barely handle things") to 4 ("Very well; I have no significant complaints"). EPO-1 is administered to all clients.
From Baseline through treatment completion (an average of 10 weeks)
Satisfaction with the Treatment Received Scale (CRES-4)
Time Frame: At the treatment completion visit, approximately 10 weeks post-enrollment.
The CRES-4 scale has 4 items: one question on satisfaction, one on the level of resolution of the main problem, one on emotional state before the start of treatment, and one on emotional state when completing the questionnaire. These questions allow interpretations of the perceived change in their emotional state, satisfaction, and problem resolution. In this study, the Spanish version of this measure will be used.CRES-4 is administered to all clients.
At the treatment completion visit, approximately 10 weeks post-enrollment.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
CORE Therapy Assessment Form (CORE-A-TAF)
Time Frame: CORE-A-TAF is completed by the therapists at baseline
The CORE-A-TAF is a pragmatic form intended to be completed 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. We will use its Spanish version, which is currently being translated and adapted for use by the CLIP.
CORE-A-TAF is completed by the therapists at baseline
CORE End of Therapy (CORE-A-EoT)
Time Frame: CORE EoT is completed by the therapists immediately after treatment completion
The CORE-A-EoT is a pragmatic form designed to be filled out by therapists immediately after treatment completion. The CORE-A-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. We will use its Spanish version, which is currently being translated and adapted for use by the CLIP.
CORE EoT is completed by the therapists immediately after treatment completion
Assessment questionnaire on the personal style of the therapist (PST-Q)
Time Frame: Baseline (Enrollment), 12 months, 24 months, and 36 months.
The PST-Q is a 20-item self-report instrument with a 7-point Likert scale (1 "Completely Disagree" to 7 "Completely Agree"). It assesses the therapist's position across five dimensions: instructional, expressive, involvement, attentional, and operative. Therapists will complete the PST-Q.
Baseline (Enrollment), 12 months, 24 months, and 36 months.
Service Information Form
Time Frame: Baseline (Enrollment), 12 months, 24 months, and 36 months.
This form is intended to be completed by the supervisors or authorities of each service. It collects general data about the center, such as the type of population it serves, its annual average number of users, etc. Supervisors will complete this form.
Baseline (Enrollment), 12 months, 24 months, and 36 months.

Collaborators and Investigators

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

Sponsor

Universidad de las Americas - Quito

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

Helpful Links

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)

February 21, 2025

Primary Completion (Estimated)

February 29, 2028

Study Completion (Estimated)

August 31, 2028

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

November 25, 2025

First Posted (Actual)

December 2, 2025

Study Record Updates

Last Update Posted (Actual)

December 2, 2025

Last Update Submitted That Met QC Criteria

November 25, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-OBS-033

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

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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