Psychological DistressNCT05343741

Practice-Based Evidence in Psychotherapy in Ecuador

An observational study of Psychological Distress, run by Universidad de las Americas - Quito at 1 site in Ecuador.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Trial 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 Read more about this study

Who is it for?: Ages 11 to 100 years
Conditions the study is for: Psychological Distress
What is being tested?: Psychological Intervention
How many people: 340 participants
Where: 1 siteEcuador
Study dates: 17 Oct 2022to Jun 2026
Phase: Observational
Are there results?: Not yet: the study is under way

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 to 100 years
All sexes
Child, Adult, Older adult

Study population: Helpseeking clients undergoing treatment at the Centro de Psicología Aplicada of the Universidad de Las Américas

Who may be able to join

Be 11 years of age or older.
Have sufficient ability to communicate in Spanish.
Undergo psychological treatment at the CPA.

Who cannot join

Present substantial cognitive deficits that do not allow the development of the evaluation.

Trial locations and contacts

1 site in 1 country.

Ecuador1 site

Centro de Psicología Aplicada
Quito, Pichincha

Other trials in Ecuador

About this study

Official title: Practice-Based Evidence in Ecuador: Routine Outcome Monitoring in Psychotherapy for Common Mental Health Problems

Read the 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.

Conditions: Psychological Distress
Being tested: Psychological Intervention
Keywords: practice-based evidence, routine outcome monitoring, psychotherapy, change, outcome, psychological distress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Psychological InterventionOther
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.

Study groups in NCT05343741
Study group	Role	What they receive
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. Receives: Other: 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 (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).
Measured: CORE-OM is administered to adult clients at baseline and immediately after treatment completion
Change in Clinical Outcomes in Routine Evaluation-10 (CORE-10)
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).
Measured: CORE-10 is administered to adult clients at the second week and then routinely every week until treatment completion
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 (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.
Measured: YP-CORE is administered to adolescent clients at baseline and then routinely every week until treatment completion

Secondary outcomes (5)

Change in Life Satisfaction Scale
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.
Measured: Life Satisfaction Scale is administered to all clients at baseline and immediately after treatment completion
Change in Ambivalence in Psychotherapy Questionnaire (APQ)
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.
Measured: APQ is administered to adult clients at baseline and then routinely every four weeks
Change in Systemic Clinical Outcome and Routine Evaluation-15 (SCORE-15)
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).
Measured: SCORE-15 is administered to all clients at baseline, at four weeks and immediately after treatment completion
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 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).
Measured: CRES-4 is administered to all clients immediately after treatment completion
Change in Therapeutic Alliance Scale
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.
Measured: Therapeutic Alliance Scale is administered to all clients immediately after the first intervention and then routinely every week until treatment completion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Oct 2022Jun 2026

First posted25 Apr 2022
Study start17 Oct 2022
Primary completion20 Jul 2025
Study completionJun 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)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)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05343741
Sponsor's protocol ID: 20211202_jvaldiviezo
Status last verified: Nov 2025
First submitted: 31 Mar 2022
Last updated: 5 Dec 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

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.
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.
PubMed 26641370
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.
PubMed 11772852
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.
PubMed 29892966
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.
PubMed 32285558
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.
PubMed 32873334
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.
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.
PubMed 27382288
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.
PubMed 37225267

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Efficacy, and Cost-effectiveness of an Online ACT Intervention for Disorders of Gut-Brain Interaction (iACTforDGBI)
Disorders of Gut-brain Interaction, Distress, Psychological
Recruiting
Comparing Telephone Symptom Monitoring Interventions for Managing Symptoms and Psychological Distress During Oral Anti-Cancer Treatment
Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Recruiting
Psychological Factors Influencing Cancer Post-traumatic Growth
Cancer
Not yet recruiting
Testing a Non-Deceptive Placebo Intervention for Subclinical Depressive Symptoms
Depression - Major Depressive Disorder, Psychological Distress
Not yet recruiting
EMI for Reducing Psychological Distress in Young Adults With Multiple ACEs: A RCT Study
Psychological Distress, Adverse Childhood Experience

All Psychological Distress trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Practice-Based Evidence in Ecuador: Routine Outcome Monitoring in Psychotherapy for Common Mental Health Problems
ClinicalTrials.gov ID: NCT05343741
Acronym / sponsor ID: 20211202_jvaldiviezo
Conditions: Psychological Distress
Keywords: practice-based evidence, routine outcome monitoring, psychotherapy, change, outcome, psychological distress
Study type: Observational
Recruitment status: Active, not recruiting
Enrolment: 340 participants (estimated)
Lead sponsor: Universidad de las Americas - QuitoUniversity, hospital or other
Study start: 17 Oct 2022 (actual)
Primary completion: 20 Jul 2025 (actual)
Study completion: Jun 2026 (estimated)
First posted: 25 Apr 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Helpseeking Ecuadorian adult and adolescent clients	–	Other: Psychological InterventionThe 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.

Who may qualify

Ages: 11 to 100 years
Sex: All
Age groups: Child, Adult, Older adult
Study population: Helpseeking clients undergoing treatment at the Centro de Psicología Aplicada of the Universidad de Las Américas

Key inclusion criteria (3 listed)

Be 11 years of age or older.
Have sufficient ability to communicate in Spanish.
Undergo psychological treatment at the CPA.

Key exclusion criteria (1 listed)

Present substantial cognitive deficits that do not allow the development of the evaluation.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Psychological InterventionThe 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.	Other	Helpseeking Ecuadorian adult and adolescent clients

Primary outcome

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.

5 secondary outcomes

Change in Life Satisfaction Scale
Time frame: Life Satisfaction Scale is administered to all clients at baseline and immediately after treatment completion
Change in Ambivalence in Psychotherapy Questionnaire (APQ)
Time frame: APQ is administered to adult clients at baseline and then routinely every four weeks
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
Satisfaction with the Treatment Received Scale (CRES-4)
Time frame: CRES-4 is administered to all clients immediately after treatment completion
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

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
BackgroundBarkham 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.
Background: PubMed 26641370Barkham 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.
Background: PubMed 11772852Evans 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.
BackgroundEvans 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
Background: PubMed 29892966Feixas 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.
BackgroundFeixas 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.
BackgroundFeixas, 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.
Background: PubMed 32285558Oliveira 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.
Background: PubMed 32873334Paz 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.
BackgroundRivas 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.
BackgroundStratton 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.
Background: PubMed 27382288Trujillo 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.
Individual participant dataSharing planned: Undecided

Related trials for Psychological Distress

Recruiting
Efficacy, and Cost-effectiveness of an Online ACT Intervention for Disorders of Gut-Brain Interaction (iACTforDGBI)
Disorders of Gut-brain Interaction, Distress, Psychological
Recruiting
Comparing Telephone Symptom Monitoring Interventions for Managing Symptoms and Psychological Distress During Oral Anti-Cancer Treatment
Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Recruiting
Psychological Factors Influencing Cancer Post-traumatic Growth
Cancer
Not yet recruiting
Testing a Non-Deceptive Placebo Intervention for Subclinical Depressive Symptoms
Depression - Major Depressive Disorder, Psychological Distress
Not yet recruiting
EMI for Reducing Psychological Distress in Young Adults With Multiple ACEs: A RCT Study
Psychological Distress, Adverse Childhood Experience

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jorge Valdiviezo-Oña, MSc principal investigator

University of Americas - Chili

Clara Paz, PhD study director

University of Americas - Chili

Adrián Montesano del Campo, PhD study director

Universitat Oberta de Catalunya

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Psychological Distress, run by Universidad de las Americas - Quito at 1 site in Ecuador.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ecuador. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05343741, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.