Self-Help Plus Pilot Study, Colombia: Train2Care

Official title

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

Overview

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

• 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.

Primary outcome measures

• Wellbeing - patient-defined mental health problems and functioning [Time frame: Baseline]
• Wellbeing - patient-defined mental health problems and functioning [Time frame: Immediately after the intervention]
• Wellbeing - patient-defined mental health problems and functioning [Time frame: 3 months follow-up]
• WHO-5 Well-being Index [Time frame: Baseline]
• WHO-5 Well-being Index [Time frame: Immediately after the intervention]
• WHO-5 Well-being Index [Time frame: 3 months follow-up]

Secondary outcome measures (6)

• Depression symptom severity [Time frame: Baseline]
• Depression symptom severity [Time frame: Immediately after the intervention]
• Depression symptom severity [Time frame: 3 months follow-up]
• Generalized anxiety symptom severity [Time frame: Baseline]
• Generalized anxiety symptom severity [Time frame: Immediately after the intervention]
• Generalized anxiety symptom severity [Time frame: 3 months follow-up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Prevention

Study locations

Colombia · 1 center

• Universidad Catolica del Oriente — Rionegro

Publications

• 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.
• 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. PMID 33533904
• 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 PMID 30314863
• 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. PMID 27371983

Identifiers

NCT: NCT07524309 · NCR267175

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗