NCT07524309

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

May 15, 2026

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

February 23, 2026

Last Update Submit

April 6, 2026

Conditions

Wellbeing

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (6)

  • Depression symptom severity

    Baseline

  • Depression symptom severity

    Immediately after the intervention

  • Depression symptom severity

    3 months follow-up

  • Generalized anxiety symptom severity

    Baseline

  • Generalized anxiety symptom severity

    Immediately after the intervention

  • +1 more secondary outcomes

Study Arms (1)

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.

Other: Self help plus

Interventions

Self help plusOTHER

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.

Self Help Plus intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old and living in the study area

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Catolica del Oriente

Rionegro, Antioquia, Colombia

Location

Related Publications (5)

  • 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.

    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.

    PMID: 33533904BACKGROUND

  • 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.

    PMID: 30314863BACKGROUND

  • 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: 27371983BACKGROUND

Study Officials

  • Nathalia Rey Gómez

    Universidad Catolica de Colombia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathalia Rey Gómez

CONTACT

+57 317 6993422nprey@ucatolica.edu.co

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Center for Global Mental Health Equity

Study Record Dates

First Submitted

February 23, 2026

First Posted

April 13, 2026

Study Start (Estimated)

May 15, 2026

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CO(1)