About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18 years old and living in the study area

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

Self help plus
Other intervention
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.

Treatment groups

40 Participants

are divided into 1 treatment group

Group A: Self Help Plus interventionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame

Baseline

2

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.

Time frame

Immediately after the intervention

3

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.

Time frame

3 months follow-up

4

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.

Time frame

Baseline

Secondary outcomes

1

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.

Time frame

Baseline

2

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.

Time frame

Immediately after the intervention

3

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.

Time frame

3 months follow-up

4

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.

Time frame

Baseline

Self-Help Plus Pilot Study, Colombia: Train2Care

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts