跳至主要内容
临床试验/NCT07257848
NCT07257848招募中不适用

Practice-Based Evidence in Ecuador: Routine Monitoring of Outcomes and Change in Psychotherapy for Common Mental Health Problems

Universidad de las Americas - Quito11 个研究点 分布在 1 个国家目标入组 340 人开始时间: 2025年2月21日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
340
试验地点
11
主要终点
Change in Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM)

研究概览

简要总结

The goal of this observational study is to learn about the progress and outcomes of clients receiving psychotherapy for common mental health problems in Ecuador. The main questions it aims to answer are:

  • How much do clients' psychological distress typically change during the course of their psychotherapy?
  • What factors are associated with outcomes in real-world mental health services in Ecuador?

This study involves clients who are about to start psychotherapy at one of the participating mental health clinics in Ecuador. Participants will continue their regular psychotherapy sessions as usual. The only addition is that before their sessions, they will be asked to complete questionnaires about their general well-being. This routine check-in process will continue throughout their time in therapy. Contextual information will be collected before starting treatment, and satisfaction with the treatment and any contextual changes will be collected after treatment ends.

详细描述

This project is an exploratory, descriptive, and longitudinal naturalistic study. Its primary objective is to systematically examine client progress and treatment outcomes across a network of psychological care services in Ecuador by implementing a Routine Outcome Monitoring system. As a naturalistic investigation, the study will be conducted within existing clinical settings, ensuring that findings reflect real-world therapeutic practices with adolescent and adult populations.

The research will be implemented across multiple psychological care centers throughout Ecuador. To provide a comprehensive understanding of therapeutic processes, data will be collected at three distinct levels. At the client level, psychological distress serves as the primary outcome variable, supplemented by sociodemographic information collected at pre-treatment and post-treatment intervals and treatment satisfaction measures at post-treatment. At the therapist level, clinicians will complete client intake forms at treatment initiation and personal style questionnaires at treatment conclusion. Additionally, service-level data will be gathered from each participating center to characterize operational contexts and organizational frameworks.

The anticipated outcomes of this initiative are substantial. It will establish systematic tracking of client progress throughout therapy, enabling identification of population-specific levels of psychological distress and change trajectories. Furthermore, the project aims to create a foundational framework for the widespread implementation of outcome measurement systems in Ecuador's mental health care context.

In the long term, this project seeks to promote the consistent and generalized adoption of Routine Outcome Monitoring systems, thereby contributing to the development of a Practice-Based Evidence culture in Ecuador and throughout Latin America. It will strengthen Practice-Based Research Networks in psychological interventions, particularly through collaboration with established organizations such as the Consorcio Latinoamericano de Investigación en Psicoterapia (CLIP), fostering regional cooperation and standardizing assessment methodologies across mental health services.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
11 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Be 11 years of age or older.
  • Have sufficient ability to communicate in Spanish.
  • Undergo psychological treatment at one of the mental health services included in the project.

排除标准

  • Present substantial cognitive deficits that do not allow the development of the evaluation.
  • Inclusion Criteria:
  • Therapist providing psychological treatment at one of the mental health services included in the project.
  • Supervisors
  • Inclusion Criteria:
  • Provide clinical supervision to therapists delivering treatment at any of the project's affiliated mental health services.

结局指标

主要结局

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

时间窗: At baseline and immediately after treatment completion

The CORE-OM is a 34-item self-report instrument designed for use across heterogeneous services and grounded in a pan-theoretic core of psychological distress, including subjective well-being, problems, risk, and functioning. Items are scored on a scale from 0 (never) to 4 (always or almost always). Higher scores indicate greater psychological distress. This instrument is suitable as an initial assessment tool and as an outcome measure. The Spanish version of this measure will be used. This version was translated in Spain and has shown good psychometric properties in Spain and Ecuador. CORE-OM is administered to adult clients.

Change in Clinical Outcomes in Routine Evaluation-10 (CORE-10)

时间窗: From the second treatment session through treatment completion (an average of 10 weeks)

The CORE-10 is a generic, short, and easy-to-use assessment measure. Its items were drawn from the CORE-OM. The CORE-10 is an instrument that has shown good psychometric properties and is practical for use on a session-by-session basis with people presenting with psychological distress in mental health settings. Its Spanish version will be used. In Ecuador, this version has shown good psychometric properties. CORE-10 is administered to adult clients.

Change in Young Person's-Clinical Outcomes in Routine Evaluation (YP-CORE)

时间窗: From baseline through treatment completion (an average of 10 weeks)

The YP-CORE is a brief self-report instrument capable of detecting psychological distress in adolescents, generated by a wide range of problems, while providing information about the person's general functioning. It has 10 items, which must be answered on a 5-point scale (0 to 4). Its Spanish version will be used. The YP-CORE was translated into Spanish and showed adequate psychometric properties. In the present study, we will use a version of this measure, adapted for Ecuador and Latin America, which has good psychometric properties in Ecuador. YP-CORE is administered to adolescents.

次要结局

  • Satisfaction with the Treatment Received Scale (CRES-4)(At the treatment completion visit, approximately 10 weeks post-enrollment.)
  • Emotional and Psychological Outcome (EPO-1)(From Baseline through treatment completion (an average of 10 weeks))

研究者

发起方
Universidad de las Americas - Quito
申办方类型
Other
责任方
Principal Investigator
主要研究者

Clara Paz

Researcher

Universidad de las Americas - Quito

研究点 (11)

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