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New study offers hope for migrant mental health with remote therapy

NCT ID NCT06635486

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests a culturally adapted cognitive-behavioral therapy (CBT) program for Venezuelan migrants in Lima, Peru, who struggle with anxiety, depression, or PTSD. The intervention is delivered remotely by trained lay providers over 6 to 12 weekly sessions. The goal is to see if this approach is feasible and helps reduce symptoms.

What this could mean

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

Active substance
culturally adapted cognitive-behavioral therapy (CBT) delivered by trained lay providers
What this could lead to
If it works, this could provide an accessible, effective mental health treatment for displaced populations facing anxiety, depression, and PTSD.
What could go wrong
This is a small, early-stage feasibility study (90 participants) with no control group, so results may not be generalizable. The intervention is remote and relies on lay providers, which may affect consistency.

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 90 people

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

Started

Apr 2025

Expected to finish

Jun 2027

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

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: To be eligible to participate in this study, an individual must meet all of the following criteria: * have Venezuelan nationality * have arrived in Lima in years 2014 to the present * be 18 years of age or older In addition, in order to be eligible to participate in this study, an individual must meet one of the following criteria: * score 10 points or more at the Patient Health Questionnaire (PHQ-9) or * score 10 points or more at the General Anxiety Disorder (GAD-7) or * have a history of trauma exposure as listed in the Life Events Checklist (LEC-5) and score 31 points or more in the PTSD Checklist (PCL-5) Exclusion Criteria: An individual is excluded from the study if they respond positively to one or more of the following questions during screening: * Suicidal ideation: "When someone feels as upset as you do, they may have thoughts that life isn't worth living. What thoughts have you had like this?" * Homicidal ideation: "When someone feels as upset as you do, they may have thoughts about hurting the person who has upset or hurt them. What thoughts have you had like this?" * Psychosis: "Do you have a diagnosis of psychosis or schizophrenia?"

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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 del Pacifico

    RECRUITING

    Lima, Peru

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