Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Universidad Católica De Colombia | UNKNOWN |
| Universidad Católica de Oriente | UNKNOWN |
| Fundación Universitaria Católica del Norte | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nathalia Rey Gómez | Contact | +57 317 6993422 | nprey@ucatolica.edu.co |
| Name | Affiliation | Role |
|---|---|---|
| Nathalia Rey Gómez | Universidad Catolica de Colombia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Catolica del Oriente | Rionegro | Antioquia | Colombia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| Background | 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. | ||
| 33533904 | Background | 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. | |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 30, 2026 | Apr 6, 2026 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |
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 |
| Background |
| 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. |
| 27371983 | Background | 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. |