Practice-Based Evidence in Psychotherapy in Ecuador
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05343741|
Recruitment Status : Recruiting
First Posted : April 25, 2022
Last Update Posted : October 19, 2022
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment|
|Psychological Distress||Other: Psychological Intervention|
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 :||Observational|
|Estimated Enrollment :||340 participants|
|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|
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.
- 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).
- 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).
- 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.
- 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.
- 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.
- 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).
- 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).
- 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.
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||11 Years to 100 Years (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Sampling Method:||Non-Probability Sample|
- Be 11 years of age or older.
- Have sufficient ability to communicate in Spanish.
- Undergo psychological treatment at the CPA.
- Present substantial cognitive deficits that do not allow the development of the evaluation.
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
|Contact: Jorge Valdiviezo-Oña, MSc||+5933981000 ext firstname.lastname@example.org|
|Contact: Clara Paz, PhD||+5933981000 ext email@example.com|
|Centro de Psicología Aplicada||Recruiting|
|Quito, Pichincha, Ecuador|
|Contact: Pablo Molina, M.Sc. 3981000 ext 667 firstname.lastname@example.org|
|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|
|Responsible Party:||Jorge Valdiviezo Oña, Prof., Universidad de las Americas - Quito|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
routine outcome monitoring