An observational study in Psychological Distress, sponsored by Universidad de las Americas - Quito. Recruiting at 11 sites in Ecuador. Open to participants aged 11 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-02.
Sponsored by Universidad de las Americas - Quito · Observational
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:
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.
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.
Universidad de las Americas - Quito is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
The participant pool will consist of three groups: (1) help-seeking clients engaged in treatment, (2) therapists providing services, and (3) supervisors from the project's affiliated mental health services in Ecuador.
Clients
Inclusion Criteria:
Exclusion Criteria:
Therapists
Inclusion Criteria:
Supervisors
Inclusion Criteria:
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.
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.
Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM)
The CORE-OM is a 34-item self-report instrument designed for use across heterogeneous services and grounded in 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 version of this measure will be used. This version was translated in Spain and has shown good psychometric properties in Spain and Ecuador. CORE-OM is administered to adult clients.
Time frame: At baseline and immediately after treatment completion
Change in Clinical Outcomes in Routine Evaluation-10 (CORE-10)
The CORE-10 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 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. In Ecuador, this version has shown good psychometric properties. CORE-10 is administered to adult clients.
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)
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. 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 into Spanish and showed adequate psychometric properties. In the present study, we will use a version of this measure, adapted for Ecuador and Latin America, which has good psychometric properties in Ecuador. YP-CORE is administered to adolescents.
Time frame: From baseline through treatment completion (an average of 10 weeks)
Emotional and Psychological Outcome (EPO-1)
The EPO-1 is a single-item outcome measure in which clients assess their current emotional and psychological state by responding to the question: "At this moment, how are you doing emotionally and psychologically?" This item is scored on a 5-point scale ranging from 0 ("Very bad; I can barely handle things") to 4 ("Very well; I have no significant complaints"). EPO-1 is administered to all clients.
Time frame: From Baseline through treatment completion (an average of 10 weeks)
Satisfaction with the Treatment Received Scale (CRES-4)
The CRES-4 scale has 4 items: one question on satisfaction, one on the level of resolution of the main problem, one on emotional state before the start of treatment, and one on emotional state when completing the questionnaire. These questions allow interpretations of the perceived change in their emotional state, satisfaction, and problem resolution. In this study, the Spanish version of this measure will be used.CRES-4 is administered to all clients.
Time frame: At the treatment completion visit, approximately 10 weeks post-enrollment.
CORE Therapy Assessment Form (CORE-A-TAF)
The CORE-A-TAF is a pragmatic form intended to be completed 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. We will use its Spanish version, which is currently being translated and adapted for use by the CLIP.
Time frame: CORE-A-TAF is completed by the therapists at baseline
CORE End of Therapy (CORE-A-EoT)
The CORE-A-EoT is a pragmatic form designed to be filled out by therapists immediately after treatment completion. The CORE-A-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. We will use its Spanish version, which is currently being translated and adapted for use by the CLIP.
Time frame: CORE EoT is completed by the therapists immediately after treatment completion
Assessment questionnaire on the personal style of the therapist (PST-Q)
The PST-Q is a 20-item self-report instrument with a 7-point Likert scale (1 "Completely Disagree" to 7 "Completely Agree"). It assesses the therapist's position across five dimensions: instructional, expressive, involvement, attentional, and operative. Therapists will complete the PST-Q.
Time frame: Baseline (Enrollment), 12 months, 24 months, and 36 months.
Service Information Form
This form is intended to be completed by the supervisors or authorities of each service. It collects general data about the center, such as the type of population it serves, its annual average number of users, etc. Supervisors will complete this form.
Time frame: Baseline (Enrollment), 12 months, 24 months, and 36 months.
Plan to share: Undecided
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Universidad de las Americas - Quito