- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05343741
Practice-Based Evidence in Psychotherapy in Ecuador
Practice-Based Evidence in Ecuador: Routine Outcome Monitoring in Psychotherapy for Common Mental Health Problems
Study Overview
Status
Conditions
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
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Pichincha
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Quito, Pichincha, Ecuador
- Centro de Psicología Aplicada
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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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).
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CORE-OM is administered to adult clients at baseline and immediately after treatment completion
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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
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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).
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CORE-10 is administered to adult clients at the second week and then routinely every week until treatment completion
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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
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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.
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YP-CORE is administered to adolescent clients at baseline and then routinely every week until treatment completion
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Life Satisfaction Scale
Time Frame: Life Satisfaction Scale is administered to all clients at baseline and immediately after treatment completion
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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.
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Life Satisfaction Scale is administered to all clients at baseline and immediately after treatment completion
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Change in Ambivalence in Psychotherapy Questionnaire (APQ)
Time Frame: APQ is administered to adult clients at baseline and then routinely every four weeks
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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.
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APQ is administered to adult clients at baseline and then routinely every four weeks
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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
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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).
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SCORE-15 is administered to all clients at baseline, at four weeks and immediately after treatment completion
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Satisfaction with the Treatment Received Scale (CRES-4)
Time Frame: CRES-4 is administered to all clients immediately after treatment completion
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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).
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CRES-4 is administered to all clients immediately after treatment completion
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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
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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.
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Therapeutic Alliance Scale is administered to all clients immediately after the first intervention and then routinely every week until treatment completion
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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CORE Therapy Assessment Form (TAF)
Time Frame: CORE TAF is completed at baseline
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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.
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CORE TAF is completed at baseline
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CORE End of Therapy (EoT)
Time Frame: CORE EoT is completed immediately after treatment completion
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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.
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CORE EoT is completed immediately after treatment completion
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Collaborators and Investigators
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
General Publications
- 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.
- 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.
- Barkham M, Bewick B, Mullin T, Gilbody S, Connell J, Cahill J, Mellor-Clark J, Richards D, Unsworth G, Evans C. The CORE-10: A short measure of psychological distress for routine use in the psychological therapies. Counselling and Psychotherapy Research. 2013; 13(1): 3-13.
- Barkham M, Mellor-Clark J, Stiles WB. A CORE approach to progress monitoring and feedback: Enhancing evidence and improving practice. Psychotherapy (Chic). 2015 Dec;52(4):402-11. doi: 10.1037/pst0000030.
- Evans C, Connell J, Barkham M, Marshall C, Mellor-Clark J. Practice-based evidence: benchmarking NHS primary care counselling services at national and local levels. Clinical Psychology & Psychotherapy: An International Journal of Theory & Practice. 2003; 10(6): 374-388
- Feixas G, Badia E, Bados A, Medina JC, Grau A, Magallon E, Botella L, Evans C. Adaptation and psychometric properties of the spanish version of the yp-core (Young Person's Clinical Outcomes in Routine Evaluation). Actas Esp Psiquiatr. 2018 May;46(3):75-82. Epub 2018 May 1.
- Feixas G, Evans C, Trujillo A, Saúl LÁ, Botella L, Corbella S, González S, Bados A, Garcia-Grau A, López-González. M. La version española del CORE-OM: Clinical Outcomes in Routine Evaluation - Outcome Measure. Revista de Psicoterapia. 2012; 23(89): 109-135.
- Feixas, G, Pucurull O, Roca C, Paz C, García-Grau E, Bados, A. Escala de satisfacción con el tratamiento recibido (CRES-4): la versión en español. Revista de Psicoterapia. 2012; 23(89): 51-58.
- Oliveira JT, Ribeiro AP, Goncalves MM. Ambivalence in Psychotherapy Questionnaire: Development and validation studies. Clin Psychol Psychother. 2020 Sep;27(5):727-735. doi: 10.1002/cpp.2457. Epub 2020 Apr 27.
- 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.
- Rivas G, Pereira R. Validación de una escala de evaluación familiar: adaptación del SCORE-15 con normas en español. Mosaico: revista de la Federación Española de Asociaciones de Terapia Familiar. 2016; 63: 16-28.
- Stratton P, Bland J, Janes E, Lask J. Developing an indicator of family function and a practicable outcome measure for systemic family and couple therapy: the SCORE. Journal of family therapy. 2010; 32(3): 232-258.
- Twigg E, Barkham M, Bewick BM, Mulhern B, Connell J, Cooper M. The YP-CORE: Development and validation of a young person's version of the CORE-OM. Counselling and Psychotherapy Research. 2009; 9: 160-168.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20211202_jvaldiviezo
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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