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NCT Number: NCT07524309

Self-Help Plus Pilot Study, Colombia: Train2Care

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.

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Key information

Conditions

Wellbeing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self help plus

Other

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.

Primary outcomes

  1. Wellbeing - patient-defined mental health problems and functioning

    Time frame: 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.

  2. Wellbeing - patient-defined mental health problems and functioning

    Time frame: 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.

  3. Wellbeing - patient-defined mental health problems and functioning

    Time frame: 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.

  4. WHO-5 Well-being Index

    Time frame: 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.

  5. WHO-5 Well-being Index

    Time frame: 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.

  6. WHO-5 Well-being Index

    Time frame: 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.

Secondary outcomes

  1. Depression symptom severity

    Time frame: Baseline

    The 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.

  2. Depression symptom severity

    Time frame: Immediately after the intervention

    The 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.

  3. Depression symptom severity

    Time frame: 3 months follow-up

    The 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.

  4. Generalized anxiety symptom severity

    Time frame: Baseline

    The 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.

  5. Generalized anxiety symptom severity

    Time frame: Immediately after the intervention

    The 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.

  6. Generalized anxiety symptom severity

    Time frame: 3 months follow-up

    The 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nathalia Rey Gómez

CONTACT

[email protected]

+57 317 6993422

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Collaborators

  • Fundación Universitaria Católica del Norte
  • Universidad Católica De Colombia
  • Universidad Católica de Oriente

Registry information

Official study title

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

Acronym: T2C

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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