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Self-Help Plus Pilot Study, Colombia: Train2Care

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07524309
Acronym
T2C
Enrollment
40
Registered
2026-04-13
Start date
2026-05-15
Completion date
2026-10-31
Last updated
2026-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wellbeing

Brief summary

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.

Detailed description

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.

Interventions

Self-Help Plus is the World Health Organization's 5-session stress management course for large groups of up to 30 people. It is delivered by supervised, non-specialist facilitators who complete a short training course and use pre-recorded audio and an illustrated guide to teach stress management skills. The course is suitable for adults who experiences stress, wherever they live and whatever their circumstances.

Sponsors

George Washington University
Lead SponsorOTHER
Universidad Católica De Colombia
CollaboratorUNKNOWN
Universidad Católica de Oriente
CollaboratorUNKNOWN
Fundación Universitaria Católica del Norte
CollaboratorUNKNOWN

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 18 years old and living in the study area

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Wellbeing - patient-defined mental health problems and functioningBaselinePsychological 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 IndexBaselineThe 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.

Secondary

MeasureTime frameDescription
Depression symptom severityBaselineThe Patient Health Questionnaire-9 (PHQ-9) is a 9-item measure of depressive symptom severity. Total scores range from 0 to 27, with higher scores indicating worse depressive symptoms.
Generalized anxiety symptom severityBaselineThe Generalized Anxiety Disorder-7 (GAD-7) is a 7-item measure of anxiety symptom severity. Total scores range from 0 to 21, with higher scores indicating worse anxiety symptoms.

Countries

Colombia

Contacts

CONTACTNathalia Rey Gómez
nprey@ucatolica.edu.co+57 317 6993422
PRINCIPAL_INVESTIGATORNathalia Rey Gómez

Universidad Catolica de Colombia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 14, 2026