Psychological DistressCLIP_EcuadorNCT07257848
Practice-Based Evidence in Psychotherapy: A Multicentric Study From Ecuador
An observational study of Psychological Distress, run by Universidad de las Americas - Quito at 11 sites in Ecuador.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 11 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychological Distress
- What is being tested?
- Psychological Intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 340 participants
- Where
- 11 sitesEcuador
- Study dates
- 21 Feb 2025to 31 Aug 2028
- How long will I take part?
- 12 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
- Therapist providing psychological treatment at one of the mental health services included in the project.
- Supervisors
- Provide clinical supervision to therapists delivering treatment at any of the project's affiliated mental health services.
Who cannot join
- Present substantial cognitive deficits that do not allow the development of the evaluation.
- Therapists
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
Ecuador11 sites, 11 recruiting
- Recruiting
Jorge López Consultorios
Manta, Manabí, EC130203
Ruth Ozaeta, +593982890686, administracion@jlconsultorios.com
Itaty Benálcazar-Betancourt, MSc
- Recruiting
PsicoNeuro Manta
Manta, Manabí
Thays Bravo, +593996828343, thaysbf20@gmail.com
Itaty Benálcazar-Betancourt, MSc
- Recruiting
Centro de Psicología Aplicada, Universidad de Las Américas, Ecuador
Quito, (P)Pichincha, EC170503
Edgar Zúñiga, MSc, 0960154522, cpa@udla.edu.ec
jorge.valdiviezo.ona@udla.edu.ec
- Recruiting
Historie
Quito, Pichincha, EC100450
Fausto Aguilar, +593995773982, direccion.ejecutiva@historiec.com
Itaty Benálcazar-Betancourt, MSc
- Recruiting
Kumpana
Quito, Pichincha, EC170102
Sebastián Velasco, +593983576120, svelascoc00@gmail.com
Itaty Benálcazar-Betancourt, MSc
- Recruiting
Mentis Psicología
Quito, Pichincha, EC170506
Andrea De la Torre, +593991633932, belendelatorrepsi@gmail.com
Itaty Benálcazar-Betancourt, MSc
- Not yet recruiting
Equimente
Quito, Pichincha, EC170517
Andrea Oña, +593989710306, andreaona27@gmail.com
Itaty Benálcazar-Betancourt, MSc
- Recruiting
Sentir Psicología Integral
Quito, Pichincha, EC170517
María Caridad Flores, +593984802020, mflores@sentirpsicologiaintegral.com
Itaty Benálcazar-Betancourt, MSc
- Recruiting
Solo Psique
Quito, Pichincha, EC170523
Abigail Galahorrano, +593984544862, solopsique@hotmail.com
Itaty Benálcazar-Betancourt, MSc
- Recruiting
Renova - Mentis Habitus Positive
Quito, Pichincha, EC17103
Antony Basantes, +593993955547, renovamentishabitus@gmail.com
Itaty Benálcazar-Betancourt, MSc
- Recruiting
Psico Estratégico
Quito, Pichincha, EC17503
Martín Moreno, +593987585766, martin.moreno@psicoestrategico.com
Itaty Benálcazar-Betancourt, MSc
About this study
Official title: Practice-Based Evidence in Ecuador: Routine Monitoring of Outcomes and Change in Psychotherapy for Common Mental Health Problems
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.
Read the 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.
- Conditions
- Psychological Distress
- Being tested
- Psychological Intervention
- Keywords
- practice-based evidence, routine outcome monitoring, psychotherapy, practice-oriented research, change, outcome, psychological distress, Latin America, Practice Research Network, Consorcio Latinoamericano de Investigación en Psicoterapia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Helpseeking Ecuadorian adult and adolescent clients | 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. Receives: Behavioral: Psychological Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From baseline through treatment completion (an average of 10 weeks)
Secondary outcomes (2)
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.
Measured: 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.
Measured: At the treatment completion visit, approximately 10 weeks post-enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start21 Feb 2025
- Primary completion29 Feb 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 340 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Universidad de las Americas - Quito
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clara Paz, Universidad de las Americas - Quito
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07257848
- Sponsor's protocol ID
- 2024-OBS-033
- Acronym
- CLIP_Ecuador
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 39558391Paz 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.
PubMed 32297845Trujillo 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.
PubMed 27382288Paz 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.
PubMed 32873334Evans 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.
PubMed 11772852Valdiviezo-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.
PubMed 37225267Paz 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.
PubMed 42150825