Validation of the Spanish Version of the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) in Chile

December 5, 2025 updated by: Pontificia Universidad Catolica de Chile

AIM: study the psychometric properties of the Spanish version of the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM), an instrument that measures psychological distress, in the Chilean population.

SAMPLES: two clinical samples (1. outpatients from three psychotherapeutic centers; two university clinics and a family mental health clinic and 2. self-reported clinical) and two non-clinical (1. university students; and 2. general community) samples. Students and community nonstudent participants who reported receiving psychological or psychiatric treatment (exclusion criterion) were excluded from the non-clinical sample and classified as self-reported clinical.

DATA COLLECTION: In the clinical sample, data (paper questionnaire) is collected at one point if the patient is undergoing treatment and at four points (at baseline (i.e. before the first session), at 2, 5 and 8-weeks) if the patient is recruited before attending the first psychotherapy session. Participants from the second university outpatient clinic and a family mental health clinic complete a digital version. At baseline, participants are presented with the CORE-OM and the Outcome Questionnaire (OQ-45). At each follow-up point, they are presented with the CORE-OM plus mental health service evaluation items.

In the student and community samples, data is collected at two time points (i.e. baseline and retest). At baseline, participants are presented with the CORE-OM and OQ-45. After two weeks (i.e. retest) participants are presented with the CORE-OM.

The application modality in the non-clinical samples is mixed: students and general community participants complete paper or digital versions of the questionnaire in the classroom or community, respectively.

RECRUITMENT: The clinical sample is recruited at two university outpatient clinics and a family mental health clinic of Santiago.

The student sample is recruited in classrooms. The general community sample is recruited using a convenience sampling method. As in other samples, participants sign an informed consent before answering the questionnaire.

ANALYSES: internal consistency, test-retest stability, convergent validity and discrimination. Clinical cut-off values will be calculated by domain and sex between the clinical and non-clinical samples and sensitivity to change will be assessed using data from the subsample of outpatients who respond an online questionnaire before their first session and at one follow up point.

Study Overview

Status

Completed

Conditions

Detailed Description

The AIM is to study the psychometric properties of the Spanish version of the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM), an instrument that measures psychological distress, in the Chilean population.

To test internal consistency, test-retest stability, convergent validity and discrimination, the CORE-OM is applied in four SAMPLES: two clinical samples (1. outpatients from three psychotherapeutic centers; two university clinics and a family mental health clinic (n=200 ~) and 2. self-reported clinical (n=200 ~)) and two non-clinical (1. university students (n=400 ~); and 2. general community (n=300~)) samples. Students and community nonstudent participants who reported receiving psychological or psychiatric treatment (exclusion criterion) were excluded from the non-clinical sample and classified as self-reported clinical.

Specific modalities of DATA COLLECTION are used for each sample. In the clinical sample, data is collected at one time point if the patient is undergoing treatment and at four time points (at baseline (i.e. before the first session), at 2 weeks (follow-up 1), at 5 weeks (follow-up 2), and at 8 weeks (follow-up 3)) if the patient is recruited before attending the first session of psychotherapy. Participants in the clinical sample complete a paper version of the questionnaire in the waiting room of one of the university outpatient clinics. Participants from the second university outpatient and family mental health clinics complete a digital version programmed in Google forms. At baseline, participants are presented with the CORE-OM, the Outcome Questionnaire (OQ-45) and a set of sociodemographic and mental health service use items. At each follow-up point they are presented with the CORE-OM plus mental health service evaluation items.

In the student and community samples, data is collected at two time points (i.e. baseline and retest). At baseline, participants are presented with the CORE-OM, OQ-45 and a set of sociodemographic and mental health service use items. After two weeks (i.e. retest) participants are presented with the CORE-OM plus an item about mental health service use in the last 30 days.

Student and community participants are contacted via email after 2 weeks to respond the online retest questionnaire.

The application modality in the non-clinical samples is mixed: students and general community participants complete paper or digital versions of the questionnaire in the classroom or community, respectively. The digital version of the questionnaire is in surveygizmo™ and can be accessed by clicking a Uniform Resource Locator (URL) embedded in an email/message, or by scanning a Quick Response (QR) code with a smartphone.

RECRUITMENT: The clinical sample is recruited at two university outpatient clinics and a family mental health clinic of Santiago, Chile all of which provide services to patients of low to medium income. Patients in one of the university clinics are approached by research assistants in the waiting area, before or after their psychotherapy/psychiatry session. Patients meeting inclusion criteria, and willing to participate, fill out an informed consent before responding the questionnaire. Patients form the second university clinic and the family mental health clinic are referred when booking their first appointment and contacted via email by a member of the research team. Questionnaire completion and responses to risk items are reviewed within 24 hours. Treating psychiatrists/psychologists are contacted via email when their patients respond "often" or "most of the time" to items signaling self-harm and thoughts of suicide (i.e. items 9, 16, 24 and 34 of the CORE-OM or item 8 of the OQ-45).

The student sample is recruited in the classrooms of Pontificia Universidad Católica de Chile. A member of the research team presents the study and invites students to participate. Students agreeing to participate fill out an informed consent form before completing paper/digital versions of the questionnaire. Any student responding "often" or "most of the time" to items signaling self-harm and thoughts of suicide in the CORE-OM/OQ-45 receives an email from the Responsible Investigator with information about the University´s counseling services within 24 hours.

The general community sample is recruited using a convenience sampling method (e.g. contacts of research team). As in the other samples, participants sign an informed consent before answering the questionnaire.

Since the non-clinical samples serve to test stability, students/general community are asked to provide a valid email address in order to send them an email invitation after two weeks to complete the CORE-OM.

Clinical cut-off values will be calculated by domain and sex between the clinical and non-clinical samples and sensitivity to change will be assessed using data from the subsample of outpatients who respond an online questionnaire before their first session and at one follow up point.

Study Type

Observational

Enrollment (Actual)

1120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile, 8331150
        • Pontificia Universidad Catolica de Chile

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Four samples:

  1. Clinical (outpatients)
  2. Clinical (self-reported patients): university students or non-student community participant who report receiving mental health treatment

2. Non-clinical (University students) 3. Non-clinical (Community)

Description

Inclusion Criteria:

  • Born in Chile
  • Currently receiving mental health treatment at the University Outpatient Clinic (Centro Médico San Joaquín) (only Clinical Sample)
  • Currently enrolled at the Universidad Catolica de Chile (only Student Sample)

Exclusion Criteria:

  • Aged < 18
  • Currently receiving psychological, psychiatric or neurological treatment (only Student and Community Sample)
  • Full-time students (only Community Sample)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Clinical (outpatients)
Patients receiving mental health treatment at the three psychotherapeutic centers; two university clinics and a family mental health clinic
Clinical (self-reported)
Students and community nonstudent participants who were receiving psychological or psychiatric treatment
Non-clinical (Community)
Members of the community
Non-clinical (Students)
University undergraduate students

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM).
Time Frame: Baseline

A self-report questionnaire which measures general psychological distress

It consists of 34 items that assess four domains:

  1. Well-being (W)
  2. Problems/Symptoms (P)
  3. Functioning (F)
  4. Risk (R)

Each of the 34 items is scored on a 5-point scale ranging from 0 to 4. A total psychological distress score, ranging from 0 to136, can be calculated by adding all items, with higher scores indicating higher levels of psychological distress. A Well-Being dimension score, ranging from 0 to 16, can be calculated with higher scores indicating lower levels of subjective wellbeing. A Problems/Symptoms dimension score, ranging from 0 to 48, can be calculated with higher scores indicating higher levels of reported problems/distress. A Functioning dimension score, ranging from 0 to 48, can be calculated with higher scores indicating lower levels of functioning. A Risk dimension score, ranging from 0 to 24, can be calculated with higher scores indicating a greater level of risk.
Baseline
Change from baseline on the Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM) at 2 to 3 weeks.
Time Frame: Follow-up after two to three weeks (non-clinical sample)

A self-report questionnaire which measures general psychological distress

It consists of 34 items that assess four domains:

  1. Well-being (W)
  2. Problems/Symptoms (P)
  3. Functioning (F)
  4. Risk (R)

Each of the 34 items is scored on a 5-point scale ranging from 0 to 4. A total psychological distress score, ranging from 0 to136, can be calculated by adding all items, with higher scores indicating higher levels of psychological distress. A Well-Being dimension score, ranging from 0 to 16, can be calculated with higher scores indicating lower levels of subjective wellbeing. A Problems/Symptoms dimension score, ranging from 0 to 48, can be calculated with higher scores indicating higher levels of reported problems/distress. A Functioning dimension score, ranging from 0 to 48, can be calculated with higher scores indicating lower levels of functioning. A Risk dimension score, ranging from 0 to 24, can be calculated with higher scores indicating a greater level of risk.
Follow-up after two to three weeks (non-clinical sample)
Change from baseline on the Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM) at 2 to 3 weeks.
Time Frame: Follow-up after two, five and eight weeks (clinical sample)

A self-report questionnaire which measures general psychological distress

It consists of 34 items that assess four domains:

  1. Well-being (W)
  2. Problems/Symptoms (P)
  3. Functioning (F)
  4. Risk (R)

Each of the 34 items is scored on a 5-point scale ranging from 0 to 4. A total psychological distress score, ranging from 0 to136, can be calculated by adding all items, with higher scores indicating higher levels of psychological distress. A Well-Being dimension score, ranging from 0 to 16, can be calculated with higher scores indicating lower levels of subjective wellbeing. A Problems/Symptoms dimension score, ranging from 0 to 48, can be calculated with higher scores indicating higher levels of reported problems/distress. A Functioning dimension score, ranging from 0 to 48, can be calculated with higher scores indicating lower levels of functioning. A Risk dimension score, ranging from 0 to 24, can be calculated with higher scores indicating a greater level of risk.
Follow-up after two, five and eight weeks (clinical sample)
Outcome Questionnaire (OQ45/OQ45.2)
Time Frame: Baseline

A self-report questionnaire which measures general psychological distress and is designed to monitor treatment outcomes in mental health settings.

It consists of 45 items and contains three subscales:

  1. Symptom Distress (SD)
  2. Interpersonal Relations (IR)
  3. Social Role (SR)

The OQ-45 provides a total score, ranging from 0 to 180, and three subscores per subscale. Symptom Distress (SD) scores range from 0 to 100, Interpersonal Relations (IR) scores range from 0 to 44 and Social Role (SR) scores range from 0 to 36.

Higher scores reflect increased psychological distress associateed to experiencing a high number of symptoms (SD), interpersonal difficulties (IR), and/or decreased satisfaction and quality of life (SR). The clinical cut-off scores in the Chilean population are: SD=43; IR=16; SR=14 and Total Score=73.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pontificia Universidad Catolica de Chile

Investigators

  • Principal Investigator: Antonia Errazuriz, PhD, Universidad Católica de Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2019

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

September 30, 2021

Study Registration Dates

First Submitted

October 2, 2019

First Submitted That Met QC Criteria

October 8, 2019

First Posted (Actual)

October 10, 2019

Study Record Updates

Last Update Posted (Estimated)

December 12, 2025

Last Update Submitted That Met QC Criteria

December 5, 2025

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 181130009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD and related data dictionaries is available to researchers via Dataverse

IPD Sharing Time Frame

Currently available

IPD Sharing Access Criteria

For research use (authorization by PI)

IPD Sharing Supporting Information Type

  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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