Recruiting

Improving Mental Health in Forcibly Displaced Populations

ClinicalTrials.gov IDNCT06635486

PhaseNA

Enrollment90

SponsorBoston Medical Center

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Anxiety, Post Traumatic Stress Disorder, Depression

About this study

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.

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.

Primary outcomes

Anxiety (Throughout the study (on average 10 months for each participant). Outcome will be assessed every 2 weeks during the intervention (on average 3 months long), and after completion of the intervention at 1 month, 3 months, and 6 months follow-up)
Depression (Throughout the study (on average 10 months for each participant). Outcome will be assessed every 2 weeks during the intervention (on average 3 months long), and after completion of the intervention at 1 month, 3 months, and 6 months follow-up)
Post Traumatic Stress Disorder (PTSD) (Throughout the study (on average 10 months for each participant). Outcome will be assessed every 1 week during the intervention (on average 3 months long), and after completion of the intervention at 1 month, 3 months, and 6 months follow-up)
Traumatic Life Events (Throughout the study (on average 10 months for each participant). Outcome will be assessed every 2 weeks during the intervention (on average 3 months long), and after completion of the intervention at 1 month, 3 months, and 6 months follow-up)

Eligibility information

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?"

Study locations

Universidad del Pacifico, Lima, Peru

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.