Improving mental health for Venezuelan migrants in Peru
Adaptation of an Open Source Cognitive Behavioral Treatment Protocol Designed to Improve Mental Health in Forcibly Displaced Populations
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.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Boston Medical Center Academic / other |
| Locations | 1 site (Lima) |
| Trial ID | NCT06635486 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown success with culturally adapted mental health interventions for displaced populations, indicating a promising approach.
Eligibility criteria
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 this trial is running
Lima
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.