Psychological DistressNCT04122079
Validation of the Spanish Version of the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) in Chile
An observational study of Psychological Distress, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychological Distress
- How many people
- 1,120 participants
- Where
- 1 siteChile
- Study dates
- 9 Jan 2019to 30 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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)
Who may be able to join
- 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)
Who cannot join
- Aged < 18
- Currently receiving psychological, psychiatric or neurological treatment (only Student and Community Sample)
- Full-time students (only Community Sample)
Trial locations and contacts
1 site in 1 country.
Chile1 site
Pontificia Universidad Catolica de Chile
Santiago, Santiago Metropolitan, 8331150
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Psychological Distress
- Keywords
- CORE-OM, Outcome measures, Psychometric validation, Psychological distress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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:
- Well-being (W)
- Problems/Symptoms (P)
- Functioning (F)
- 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.
Measured: 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:
- Well-being (W)
- Problems/Symptoms (P)
- Functioning (F)
- 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.
Measured: 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:
- Well-being (W)
- Problems/Symptoms (P)
- Functioning (F)
- 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.
Measured: 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:
- Symptom Distress (SD)
- Interpersonal Relations (IR)
- 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start9 Jan 2019
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonia Errazuriz, PhD, Principal investigator, Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122079
- Sponsor's protocol ID
- 181130009
- Status last verified
- Oct 2019
- First submitted
- 2 Oct 2019
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD and related data dictionaries is available to researchers via Dataverse
Publications
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
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 11772852Von 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
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.
PubMed 38781596
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Spanish Version of the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) in Chile
- ClinicalTrials.gov ID
- NCT04122079
- Acronym / sponsor ID
- 181130009
- Conditions
- Psychological Distress
- Keywords
- CORE-OM, Outcome measures, Psychometric validation, Psychological distress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,120 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- 9 Jan 2019 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 10 Oct 2019 (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.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- Aged < 18
- Currently receiving psychological, psychiatric or neurological treatment (only Student and Community Sample)
- Full-time students (only Community Sample)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- BackgroundEvans, 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: 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.
- BackgroundVon 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
- Results publication: PubMed 38781596Errazuriz 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.
- Individual participant dataSharing planned: Yes. IPD and related data dictionaries is available to researchers via Dataverse
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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.
Antonia Errazuriz, PhD principal investigator
Universidad Catolica de Chile
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 Pontificia Universidad Catolica de Chile at 1 site in Chile.
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 3 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: finished, as of the sponsor's last update on 12 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 Chile. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM). (time frame: Baseline). The study lists 4 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 NCT04122079, which also lists 4 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 12 Dec 2025.