Validation of the Spanish Version of the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) in Chile
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,120
- 试验地点
- 1
- 主要终点
- Outcome Questionnaire (OQ45/OQ45.2)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •Aged < 18
- •Currently receiving psychological, psychiatric or neurological treatment (only Student and Community Sample)
- •Full-time students (only Community Sample)
结局指标
主要结局
Outcome Questionnaire (OQ45/OQ45.2)
时间窗: 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.
Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM).
时间窗: 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.
时间窗: 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.
次要结局
未报告次要终点