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

Official title

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

Overview

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

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.

Interventions

• 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.

Primary outcome measures

• Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) [Time frame: 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)]
• Change in Young Person's-Clinical Outcomes in Routine Evaluation (YP-CORE) [Time frame: From baseline through treatment completion (an average of 10 weeks)]

Secondary outcome measures (2)

• Emotional and Psychological Outcome (EPO-1) [Time frame: 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Cohort

Study locations

Ecuador · 11 centers

• Centro de Psicología Aplicada, Universidad de Las Américas, Ecuador — Quito
• Jorge López Consultorios — Manta
• PsicoNeuro Manta — Manta
• Historie — Quito
• Kumpana — Quito
• Mentis Psicología — Quito
• Equimente — Quito
• Sentir Psicología Integral — Quito
• … and 3 more centers

Publications

• 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
• 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
• 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
• 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
• 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
• 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
• Paz C, Benalcazar-Betancourt I, Valdiviezo-Ona J, Evans C. Generating practice-based evidence for common mental health problems using routine outcome monitoring: a protocol for a longitudinal naturalistic study in Ecuadorian mental health services. BMJ Open. 2026 May 18;16(5):e115254. doi: 10.1136/bmjopen-2025-115254. PMID 42150825

Identifiers

NCT: NCT07257848 · 2024-OBS-033

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗