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

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ClinicalTrials.gov Identifier: NCT04122079
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Pontificia Universidad Catolica de Chile

Brief Summary:

The aim is to study the psychometric properties of the Spanish translation 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, and discrimination, the CORE-OM is applied in three samples: a clinical sample (n=200) and two non-clinical samples (1. university students (n=400); and 2. general community (n=300)).

Specific modalities of data collection are used for each sample. In the clinical sample, data is only collected at one time point. 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, the Outcome Questionnaire (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.

Participants in the clinical sample complete the paper version of the questionnaire in the waiting room of the University Outpatient Clinic. 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.

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

The clinical sample is recruited at a University Outpatient Clinic in the Metropolitan Area of Santiago, which provides services to patients of low to medium income. Patients 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. 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.


Condition or disease
Psychological Distress

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Study Type : Observational
Estimated Enrollment : 900 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Validation of the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) in Chile
Actual Study Start Date : January 9, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Group/Cohort
Clinical
Patients receiving mental health treatment at the University outpatient clinic
Students
University undergraduate students
Community
Members of the community



Primary Outcome Measures :
  1. 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.


  2. 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 ]

    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.


  3. 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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Three samples:

  1. Clinical
  2. University students
  3. Community
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04122079


Contacts
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Contact: Antonia Errazuriz, PhD +56953631333 anerrazuriz@uc.cl

Locations
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Chile
Pontificia Universidad Catolica de Chile Recruiting
Santiago, Región Metropolitana, Chile, 8331150
Contact: Antonia Errazuriz, PhD    +56953631333    anerrazuriz@uc.cl   
Principal Investigator: Antonia Errazuriz, PhD         
Sub-Investigator: Guillermo De la Parra, PhD         
Sub-Investigator: Elyna Gomez-Barris, PhD (c)         
Sub-Investigator: Nina Immel, PhD (c)         
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Investigators
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Principal Investigator: Antonia Errazuriz, PhD Universidad Catolica de Chile

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
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

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Responsible Party: Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT04122079     History of Changes
Other Study ID Numbers: 181130009
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: There is a plan to make IPD and related data dictionaries available to researchers.
Supporting Materials: Informed Consent Form (ICF)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pontificia Universidad Catolica de Chile:
CORE-OM
Outcome measures
Psychometric validation
Psychological distress