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

NCT07257848 | Recruiting

• 1 other identifier: 2024-OBS-033
• Study Type: observational
• Target: 340
• Locations: 1 country
• Sites: 11

Brief Summary

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.

Conditions

Psychological Distress

Keywords

practice-based evidence; routine outcome monitoring; psychotherapy; practice-oriented research; change; outcome; psychological distress; Latin America; Practice Research Network; Consorcio Latinoamericano de Investigación en Psicoterapia

Outcome Measures

Primary Outcomes (3)

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

  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)

  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)

  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 Outcomes (2)

• Emotional and Psychological Outcome (EPO-1)

  From Baseline through treatment completion (an average of 10 weeks)

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

  At the treatment completion visit, approximately 10 weeks post-enrollment.

Other Outcomes (4)

• CORE Therapy Assessment Form (CORE-A-TAF)

  CORE-A-TAF is completed by the therapists at baseline

• CORE End of Therapy (CORE-A-EoT)

  CORE EoT is completed by the therapists immediately after treatment completion

• Assessment questionnaire on the personal style of the therapist (PST-Q)

  Baseline (Enrollment), 12 months, 24 months, and 36 months.

Study Arms (1)

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

Interventions

Psychological Intervention BEHAVIORAL

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.

Helpseeking Ecuadorian adult and adolescent clients

Eligibility Criteria

• Age: 11 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Present substantial cognitive deficits that do not allow the development of the evaluation.
• Therapists
• Therapist providing psychological treatment at one of the mental health services included in the project.
• Supervisors
• Provide clinical supervision to therapists delivering treatment at any of the project's affiliated mental health services.

Sponsors & Collaborators

• Universidad de las Americas - Quito: lead

Study Sites (11)

Centro de Psicología Aplicada, Universidad de Las Américas, Ecuador

Quito, (P)Pichincha, EC170503, Ecuador

RECRUITING

Jorge López Consultorios

Manta, Manabí, EC130203, Ecuador

RECRUITING

PsicoNeuro Manta

Manta, Manabí, Ecuador

RECRUITING

Historie

Quito, Pichincha, EC100450, Ecuador

RECRUITING

Kumpana

Quito, Pichincha, EC170102, Ecuador

RECRUITING

Mentis Psicología

Quito, Pichincha, EC170506, Ecuador

RECRUITING

Equimente

Quito, Pichincha, EC170517, Ecuador

NOT YET RECRUITING

Sentir Psicología Integral

Quito, Pichincha, EC170517, Ecuador

RECRUITING

Solo Psique

Quito, Pichincha, EC170523, Ecuador

RECRUITING

Renova - Mentis Habitus Positive

Quito, Pichincha, EC17103, Ecuador

RECRUITING

Psico Estratégico

Quito, Pichincha, EC17503, Ecuador

RECRUITING

Related Publications (6)

• Valdiviezo-Ona J, Ortiz-Mancheno N, Valdivieso-Arias G, Erazo-Perez D, Rodriguez-Lorenzana A, Evans C, Paz C. Assessing the suitability and psychometric properties of the Spanish version of the YP-CORE for adolescents in Latin America: a study in Ecuador. BMC Psychol. 2024 Nov 18;12(1):671. doi: 10.1186/s40359-024-02169-8.

  PMID: 39558391 BACKGROUND

• Paz C, Mascialino G, Proano K, Evans C. Psychological intervention change measurement in Latin America: Where from? Where to? Psychother Res. 2021 Jan;31(1):132-141. doi: 10.1080/10503307.2020.1750728. Epub 2020 Apr 16.

  PMID: 32297845 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: 27382288 BACKGROUND

• 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: 32873334 BACKGROUND

• 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: 11772852 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.

  PMID: 37225267 BACKGROUND

Related Links

• Website of the Consorcio Latinoamericano de Investigación en Psicoterapia (CLIP)
• MarBar is the system used for data collection in all the mental health services involved in the study
• Clinical Outcomes in Routine Evaluation meeasures information

MeSH Terms

Interventions

Psychosocial Intervention

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Clara Paz, Ph.D.

CONTACT

+593960154522; clara.paz@udla.edu.ec

Itaty Benalcázar Betancourt, M.Sc.

CONTACT

+593996482602; itatyerika.benalcazar@udla.edu.ec

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 2, 2025
• Study Start: February 21, 2025
• Primary Completion (Estimated): February 29, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

EC (11)