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Improving Mental Health in Forcibly Displaced Populations

NCT06635486 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-05-30

No results posted yet for this study

Summary

This project aims to improve mental health support for Venezuelan migrants living in Lima, Peru, who often face challenges like anxiety, depression, and post-traumatic stress disorder (PTSD). Since 2015, millions of Venezuelans have fled their country due to a severe humanitarian crisis, including extreme inflation, food shortages, and political unrest. Many of these individuals now live in Peru, where they struggle to access mental health services.

A new type of intervention that is both evidence-based and culturally adapted to meet the specific needs of Venezuelan migrants is the focus of this research. The intervention is designed to be delivered by trained lay providers-people from the community who have received special training but are not professional mental health workers. The intervention consists of 6 to 12 weekly online sessions, each lasting about an hour. These sessions will cover various therapeutic techniques, including cognitive restructuring (changing negative thought patterns), behavioral activation (encouraging positive activities), and emotional regulation (managing feelings). The sessions will be conducted remotely, allowing participants to join from the comfort of their homes.This approach is intended to make mental health care more accessible and relatable for migrants, who may feel more comfortable receiving help from someone who understands their cultural background and experiences.

Conditions

Interventions

BEHAVIORAL

Adapted cognitive-behavioral (CBT) intervention

The intervention is 6-12 sessions, depending on the symptom presentation of the participant. The weekly sessions last 60 minutes and will be delivered remotely and individually via Meet or a similar platform by trained lay providers. Intervention methods include cognitive re-structuring, behavioral activation, exposure to memories and situations, problem solving, and emotional regulation.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Boston Medical Center

    lead OTHER

Principal Investigators

  • Haley Carroll, PhD MS · Boston Medical Center, BUCA School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-15
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Peru

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06635486 on ClinicalTrials.gov