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

NCT ID: NCT07257848

Last Updated: 2025-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

340 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-21

Study Completion Date

2028-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Psychological Distress

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Psychological Intervention

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.


* 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.

Exclusion Criteria

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

Therapists
Minimum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad de las Americas - Quito

OTHER

Sponsor Role lead

Responsible Party

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Clara Paz

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Centro de Psicología Aplicada, Universidad de Las Américas, Ecuador

Quito, (P)Pichincha, Ecuador

Site Status RECRUITING

Jorge López Consultorios

Manta, Manabí, Ecuador

Site Status RECRUITING

PsicoNeuro Manta

Manta, Manabí, Ecuador

Site Status RECRUITING

Historie

Quito, Pichincha, Ecuador

Site Status RECRUITING

Kumpana

Quito, Pichincha, Ecuador

Site Status RECRUITING

Mentis Psicología

Quito, Pichincha, Ecuador

Site Status RECRUITING

Equimente

Quito, Pichincha, Ecuador

Site Status NOT_YET_RECRUITING

Sentir Psicología Integral

Quito, Pichincha, Ecuador

Site Status RECRUITING

Solo Psique

Quito, Pichincha, Ecuador

Site Status RECRUITING

Renova - Mentis Habitus Positive

Quito, Pichincha, Ecuador

Site Status RECRUITING

Psico Estratégico

Quito, Pichincha, Ecuador

Site Status RECRUITING

Countries

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Ecuador

Central Contacts

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Clara Paz, Ph.D.

Role: CONTACT

+593960154522

Itaty Benalcázar Betancourt, M.Sc.

Role: CONTACT

+593996482602

Facility Contacts

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Edgar Zúñiga, MSc

Role: primary

0960154522

Role: backup

Ruth Ozaeta

Role: primary

+593982890686

Thays Bravo

Role: primary

+593996828343

Fausto Aguilar

Role: primary

+593995773982

Sebastián Velasco

Role: primary

+593983576120

Andrea De la Torre

Role: primary

+593991633932

Andrea Oña

Role: primary

+593989710306

María Caridad Flores

Role: primary

+593984802020

Abigail Galahorrano

Role: primary

+593984544862

Antony Basantes

Role: primary

+593993955547

Martín Moreno

Role: primary

+593987585766

References

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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.

Reference Type BACKGROUND
PMID: 11772852 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39558391 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32297845 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27382288 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32873334 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37225267 (View on PubMed)

Related Links

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https://www.psychotherapyresearch.org/page/CLIP-About

Website of the Consorcio Latinoamericano de Investigación en Psicoterapia (CLIP)

https://www.marbarsystem.com/

MarBar is the system used for data collection in all the mental health services involved in the study

https://www.coresystemtrust.org.uk/

Clinical Outcomes in Routine Evaluation meeasures information

Other Identifiers

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2024-OBS-033

Identifier Type: -

Identifier Source: org_study_id

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