Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Improving mental health for Venezuelan migrants in Peru

Official title: Adaptation of an Open Source Cognitive Behavioral Treatment Protocol Designed to Improve Mental Health in Forcibly Displaced Populations

Run by Boston Medical Center · NCT06635486 · Data updated 2026-11-12

This study is testing a new online therapy program to see if it can help Venezuelan migrants in Peru who are struggling with anxiety, depression, and PTSD.

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Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment90 (estimated)
SponsorBoston Medical Center
Academic / other
Locations1 site (Lima)
StatusRecruiting
StartedApril 15, 2025
Main results expectedJune 2027
Study endsJune 2027
Registry record updatedMay 28, 2026
Trial IDNCT06635486 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are Venezuelan migrants aged 18 and older who have arrived in Lima since 2014 and are experiencing symptoms of anxiety, depression, or PTSD.

Probably not a fit

Patients who do not meet the eligibility criteria, such as those without Venezuelan nationality or those with severe suicidal or homicidal ideation, may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project aims to enhance mental health support for Venezuelan migrants in Lima, Peru, who are facing anxiety, depression, and PTSD due to their displacement. The intervention involves a culturally adapted cognitive behavioral therapy (CBT) delivered by trained community lay providers through 6 to 12 weekly online sessions. Participants will be divided into two groups: one receiving the intervention and another on a waitlist, with mental health symptoms assessed using validated questionnaires. The study will also gather feedback on the intervention's acceptability and feasibility, aiming to provide insights into effective mental health strategies for forcibly displaced individuals.

Why it matters

Potential benefit: If successful, this intervention could significantly improve the mental health outcomes of Venezuelan migrants, providing them with accessible and culturally relevant support.

How similar studies have gone: Other studies have shown success with culturally adapted mental health interventions for displaced populations, indicating a promising approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
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?"

Where it's running

  • Universidad del Pacifico
    Lima, Peru
    Recruiting

Study contacts

  • Principal investigator: Haley Carroll, PhD MS — Boston Medical Center, BUCA School of Medicine
  • Study coordinator: Haley Carroll, PhD MS
  • Email: hcarrol1@bu.edu
  • Phone: 617 414 2035

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.