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

NCT04122079 | Completed DMC

• 1 other identifier: 181130009
• Study Type: observational
• Target: 1,120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psychological Distress

Keywords

CORE-OM; Outcome measures; Psychometric validation; Psychological distress

Outcome Measures

Primary Outcomes (4)

• Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM).

  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.

  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.

  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)

  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

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

Pontificia Universidad Catolica de Chile

Santiago, Santiago Metropolitan, 8331150, Chile

Location

Related Publications (4)

• Evans, C., Mellor-Clark, J., Margison, F., Barkham, M., Audin, K., Connell, J., & McGrath, G. (2000). CORE: Clinical Outcomes in Routine Evaluation. Journal of Mental Health, 9(3), 247-255

  BACKGROUND

• 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.

  PMID: 11772852 BACKGROUND

• Von Bergen A., De la Parra G. (2002). OQ-45.2, Cuestionario para la evaluación de resultados y evolución en psicoterapia: adaptación, validación e indicaciones para su aplicación e interpretación [Questionnaire for the evaluation of results and evolution in psychotherapy: adaptation, validation and indications for its application and interpretation]. Ter. Psicol. 20 161-176

  BACKGROUND

• Errazuriz A, Passi Solar A, Beltran R, Paz C, Evans C, De la Parra G. Psychometric properties of the Spanish version of the Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM) in Chile. Psychother Res. 2025 Jul;35(6):1017-1029. doi: 10.1080/10503307.2024.2356195. Epub 2024 May 23.

  PMID: 38781596 RESULT

Study Officials

• Antonia Errazuriz, PhD

  Universidad Catolica de Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: October 10, 2019
• Study Start: January 9, 2019
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: December 12, 2025

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• Time Frame: Currently available
• Access Criteria: For research use (authorization by PI)

Locations

CL (1)