Self-Help Plus Pilot Study, Colombia: Train2Care (T2C)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Wellbeing
• Intervention / Treatment: Other: Self help plus

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nathalia Rey Gómez; Phone Number: +57 317 6993422; Email: nprey@ucatolica.edu.co

Study Locations

• Colombia
  • Antioquia
    • Rionegro, Antioquia, Colombia
      • Universidad Catolica del Oriente
      • Contact: Magda Aries; Phone Number: +67-310-320-8651; Email: myaries@uco.edu.co

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Active Comparator: Self Help Plus intervention; 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.

Other: Self help plus; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wellbeing - patient-defined mental health problems and functioning	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.	Baseline
Wellbeing - patient-defined mental health problems and functioning	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.	Immediately after the intervention
Wellbeing - patient-defined mental health problems and functioning	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 months follow-up
WHO-5 Well-being Index	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.	Baseline
WHO-5 Well-being Index	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.	Immediately after the intervention
WHO-5 Well-being Index	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.	3 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression symptom severity	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.	Baseline
Depression symptom severity	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.	Immediately after the intervention
Depression symptom severity	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 months follow-up
Generalized anxiety symptom severity	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.	Baseline
Generalized anxiety symptom severity	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.	Immediately after the intervention
Generalized anxiety symptom severity	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.	3 months follow-up

Collaborators and Investigators

• Sponsor: George Washington University
• Collaborators: Universidad Católica De Colombia; Universidad Católica de Oriente; Fundación Universitaria Católica del Norte
• Investigators: Principal Investigator: Nathalia Rey Gómez, Universidad Catolica de Colombia

Publications and helpful links

General Publications

• Singla DR, Lawson A, Kohrt BA, Jung JW, Meng Z, Ratjen C, Zahedi N, Dennis CL, Patel V. Implementation and Effectiveness of Nonspecialist-Delivered Interventions for Perinatal Mental Health in High-Income Countries: A Systematic Review and Meta-analysis. JAMA Psychiatry. 2021 May 1;78(5):498-509. doi: 10.1001/jamapsychiatry.2020.4556.
• Patel V, Saxena S, Lund C, Thornicroft G, Baingana F, Bolton P, Chisholm D, Collins PY, Cooper JL, Eaton J, Herrman H, Herzallah MM, Huang Y, Jordans MJD, Kleinman A, Medina-Mora ME, Morgan E, Niaz U, Omigbodun O, Prince M, Rahman A, Saraceno B, Sarkar BK, De Silva M, Singh I, Stein DJ, Sunkel C, UnUtzer J. The Lancet Commission on global mental health and sustainable development. Lancet. 2018 Oct 27;392(10157):1553-1598. doi: 10.1016/S0140-6736(18)31612-X. Epub 2018 Oct 9. No abstract available.
• Self Help Plus (SH+): a group-based stress management course for adults. Generic field-trial version 1.0, 2021. Geneva: World Health Organization; 2021 (Series on low-intensity psychological interventions, No. 5). Licence: CC BY-NC-SA 3.0 IGO.
• The Self-Help Plus (SH+) training manual: for training facilitators to deliver the SH+ course. Geneva: World Health Organization; 2024. Licence: CC BY-NC-SA 3.0 IGO.
• Chisholm D, Sweeny K, Sheehan P, Rasmussen B, Smit F, Cuijpers P, Saxena S. Scaling-up of treatment of depression and anxiety - Authors' reply. Lancet Psychiatry. 2016 Jul;3(7):603-4. doi: 10.1016/S2215-0366(16)30131-6. No abstract available.

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: February 23, 2026
• First Submitted That Met QC Criteria: April 6, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: NCR267175

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No