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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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)

Locations
Other Locations
Peru
Universidad del Pacifico
RECRUITING
Lima
Contact Information
Primary
Haley Carroll, PhD MS
hcarrol1@bu.edu
617 414 2035
Time Frame
Start Date: 2025-04-15
Estimated Completion Date: 2026-06
Participants
Target number of participants: 90
Treatments
Experimental: Intervention arm
Participants randomized to this arm will receive the CBT adapted intervention.
No_intervention: Wait list control arm
Participants randomized to this arm will be placed on a wait list for the CBT adapted intervention.
Related Therapeutic Areas
Sponsors
Leads: Boston Medical Center
Collaborators: National Institute of Mental Health (NIMH)

This content was sourced from clinicaltrials.gov