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WHO's Stress-Busting course gets a trial in colombia: can it help communities cope?

NCT ID NCT07524309

Symptom relief Sponsor: George Washington University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study will test a World Health Organization stress management course called Self-Help Plus in Colombia. The course uses audio guides and an illustrated booklet over five sessions, led by trained community members. Researchers will enroll 40 adults to see if the program improves wellbeing and reduces distress. The goal is to build local mental health support where professional care is scarce.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Self-Help Plus (a 5-session stress management course with audio and illustrated guide, delivered by non-specialist facilitators)
What this could lead to
If successful, this could provide a low-cost, scalable way to improve mental wellbeing in underserved communities and train local leaders to support others.
What could go wrong
This is a very small pilot study (40 people) with no control group, so results may not be generalizable. It also relies on self-reported outcomes, which can be subjective.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Wellbeing

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Universidad Catolica del Oriente

    Rionegro, Antioquia, Colombia

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