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临床试验/NCT07524309
NCT07524309尚未招募不适用

Self-Help Plus Pilot Study, Colombia: Training to Care: Global Mental Health With a Territorial Approach

George Washington University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年5月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
试验地点
1
主要终点
Wellbeing - patient-defined mental health problems and functioning

研究概览

简要总结

This project will strengthen local capacity for mental health care in high-need settings in Colombia by culturally and linguistically adapting the Self-Help+ intervention and delivering participatory, supervised training. Local community leaders will be trained to implement Self Help+ for their own well-being and to train others in their communities. The project will deliver a structured program with hands-on practice, ongoing technical support, and participatory evaluation of psychosocial outcomes and sustainability.

详细描述

The main goal of the project is to strengthen the mental health capacity of individuals living in low-income settings and community-based, public, and private organizations in Eastern Antioquia, Colombia, by culturally adapting the Self-Help+ intervention and piloting a participatory training program with key community actors, laying the groundwork for future scale-up and sustainability. The following are the objectives of the study:

  • Culturally and linguistically adapt Self-Help+ to the local context of communities in Eastern Antioquia, Colombia
  • Co-design a pilot training program on Self-Help+ delivery with key community actors using participatory methods
  • Implement the pilot training program on Self-Help+ with the selected community actors using participatory approaches
  • Conduct a preliminary mixed-methods evaluation of acceptability, feasibility, and early psychosocial outcome indicators
  • Systematize implementation data to support knowledge sharing and ongoing technical monitoring of the strategies in critical contexts.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • 18 years old and living in the study area

排除标准

  • Current risk of self-harm or suicide that requires a higher level of care
  • Significant cognitive impairment that would interfere with the ability to participate in the intervention or provide informed consent
  • Severe mental health conditions requiring specialized care (for example, psychosis)
  • Severe substance use or substance use disorders that would interfere with participation or require specialized treatment

研究组 & 干预措施

Self Help Plus intervention

Active Comparator

The Self Help Plus intervention is a five-session mental health support delivered to groups of up to 30 people. The Self-Help Plus supports the well-being of individuals facing adversity. This intervention is based on acceptance and commitment therapy and includes developing practical skills in grounding and present moment attention, mindful awareness, cognitive defusion, and valueclarification.

干预措施: Self help plus (Other)

结局指标

主要结局

Wellbeing - patient-defined mental health problems and functioning

时间窗: Baseline

Psychological Outcome Profiles (PSYCHLOPS) is a patient-generated outcome measure designed to assess problems, functioning, and well-being from the participant's perspective. Total scores typically range from 0 to 20, with higher scores indicating worse psychological distress or poorer outcomes.

Wellbeing - patient-defined mental health problems and functioning

时间窗: Immediately after the intervention

Psychological Outcome Profiles (PSYCHLOPS) is a patient-generated outcome measure designed to assess problems, functioning, and well-being from the participant's perspective. Total scores typically range from 0 to 20, with higher scores indicating worse psychological distress or poorer outcomes.

Wellbeing - patient-defined mental health problems and functioning

时间窗: 3 months follow-up

Psychological Outcome Profiles (PSYCHLOPS) is a patient-generated outcome measure designed to assess problems, functioning, and well-being from the participant's perspective. Total scores typically range from 0 to 20, with higher scores indicating worse psychological distress or poorer outcomes.

WHO-5 Well-being Index

时间窗: Baseline

The World Health Organization-Five Well-Being Index (WHO-5) is a 5-item measure of subjective psychological well-being. Raw total scores range from 0 to 25, with higher scores indicating better well-being.

WHO-5 Well-being Index

时间窗: Immediately after the intervention

The World Health Organization-Five Well-Being Index (WHO-5) is a 5-item measure of subjective psychological well-being. Raw total scores range from 0 to 25, with higher scores indicating better well-being.

WHO-5 Well-being Index

时间窗: 3 months follow-up

The World Health Organization-Five Well-Being Index (WHO-5) is a 5-item measure of subjective psychological well-being. Raw total scores range from 0 to 25, with higher scores indicating better well-being.

次要结局

  • Depression symptom severity(Baseline)
  • Depression symptom severity(Immediately after the intervention)
  • Depression symptom severity(3 months follow-up)
  • Generalized anxiety symptom severity(Baseline)
  • Generalized anxiety symptom severity(Immediately after the intervention)
  • Generalized anxiety symptom severity(3 months follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Brandon A Kohrt, MD, PhD

Director, Center for Global Mental Health Equity

George Washington University

研究点 (1)

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