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Practice-Based Evidence in Psychotherapy in Ecuador

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ClinicalTrials.gov Identifier: NCT05343741
Recruitment Status : Recruiting
First Posted : April 25, 2022
Last Update Posted : October 19, 2022
Sponsor:
Information provided by (Responsible Party):
Jorge Valdiviezo Oña, Universidad de las Americas - Quito

Study Description
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Brief Summary:
This is a naturalistic study implementing a routine outcome monitoring system to track clients' change and outcomes at the Centro de Psicología Aplicada (CPA) of the Universidad de Las Américas in Quito, Ecuador

Condition or disease Intervention/treatment
Psychological Distress Other: Psychological Intervention

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 Design
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Study Type : Observational
Estimated Enrollment : 340 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Practice-Based Evidence in Ecuador: Routine Outcome Monitoring in Psychotherapy for Common Mental Health Problems
Actual Study Start Date : October 17, 2022
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : September 2025
Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Other: Psychological Intervention
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    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).

  2. 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 ]
    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).

  3. 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 ]
    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.


Secondary Outcome Measures :
  1. Change in Life Satisfaction Scale [ Time Frame: Life Satisfaction Scale is administered to all clients at baseline and immediately after treatment completion ]
    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.

  2. Change in Ambivalence in Psychotherapy Questionnaire (APQ) [ Time Frame: APQ is administered to adult clients at baseline and then routinely every four weeks ]
    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.

  3. 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 ]
    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).

  4. Satisfaction with the Treatment Received Scale (CRES-4) [ Time Frame: CRES-4 is administered to all clients immediately after treatment completion ]
    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).

  5. 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 ]
    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.


Other Outcome Measures:
  1. CORE Therapy Assessment Form (TAF) [ Time Frame: CORE TAF is completed at baseline ]
    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.

  2. CORE End of Therapy (EoT) [ Time Frame: CORE EoT is completed immediately after treatment completion ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Helpseeking clients undergoing treatment at the Centro de Psicología Aplicada of the Universidad de Las Américas
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05343741


Contacts
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Contact: Jorge Valdiviezo-Oña, MSc +5933981000 ext 7085 jorge.valdiviezo.ona@udla.edu.ec
Contact: Clara Paz, PhD +5933981000 ext 2518 clara.paz@udla.edu.ec

Locations
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Ecuador
Centro de Psicología Aplicada Recruiting
Quito, Pichincha, Ecuador
Contact: Pablo Molina, M.Sc.    3981000 ext 667    pablo.molina@udla.edu.ec   
Sponsors and Collaborators
Universidad de las Americas - Quito
Investigators
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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
More Information
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Publications:
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.
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, 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.
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.

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Responsible Party: Jorge Valdiviezo Oña, Prof., Universidad de las Americas - Quito
ClinicalTrials.gov Identifier: NCT05343741    
Other Study ID Numbers: 20211202_jvaldiviezo
First Posted: April 25, 2022    Key Record Dates
Last Update Posted: October 19, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jorge Valdiviezo Oña, Universidad de las Americas - Quito:
practice-based evidence
routine outcome monitoring
psychotherapy
 change
outcome
psychological distress