Improving Mental Health in Forcibly Displaced Populations

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

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.

Study Overview

• Status: Recruiting
• Conditions: Depression; Anxiety; Post Traumatic Stress Disorder
• Intervention / Treatment: Behavioral: Adapted cognitive-behavioral (CBT) intervention

Detailed Description

To assess the effectiveness of this intervention, 90 participants will be assigned into two groups: one that receives the intervention and another that will be on a waitlist for later participation. The investigators will measure changes in mental health symptoms using validated questionnaires throughout the study and at follow-up intervals. Participants will also provide feedback on their experience, providing information on how acceptable and feasible this approach is.

The three goals of the trial are:

1. Efficacy: To determine if the intervention effectively reduces symptoms of anxiety, depression, and PTSD among participants.
2. Feasibility and Acceptability: To evaluate how practical and well-received the intervention is by both participants and providers.
3. Understanding Moderating Factors: To explore how individual experiences related to migration and integration affect the success of the intervention.

By focusing on a vulnerable population that often lacks access to traditional mental health resources, this project aims to provide valuable insights into effective mental health strategies for forcibly displaced individuals. If successful, the findings could help inform community leaders, non-governmental organizations (NGOs), and health care providers about how to better support Venezuelan migrants and potentially other migrant groups facing similar challenges in resource-limited settings.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Haley Carroll, PhD MS; Phone Number: 617 414 2035; Email: hcarrol1@bu.edu

Study Locations

• Peru
  • Lima, Peru
    • Recruiting
    • Universidad del Pacifico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm; Participants randomized to this arm will receive the CBT adapted intervention.	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.; Other Names: A culturally adapted transdiagnostic CBT intervention
No Intervention: Wait list control arm; Participants randomized to this arm will be placed on a wait list for the CBT adapted intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	Anxiety will be assessed using the 7-item Generalized Anxiety Disorder (GAD-7). Each item is scored from 0 to 3, where 0= Not at all and 3= Nearly every day, with a range of scores from 0 to 21. The interpretation of scores are: 0 - 4: Minimal anxiety, 5 - 9: Mild anxiety, 10 -14: Moderate anxiety, and 15+: Severe 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	Depression will be assessed using the 9-item Patient Health Questionnaire (PHQ-9). Each item is scored from 0 to 3, where 0= Not at all and 3= Nearly every day, with a range of scores from 0 to 27. The interpretation of scores are: 0-4: No or minimal depression, 5-9: Mild depression, 10-14: Moderate depression, 15-19: Moderately severe depression, 20-27: Severe 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)	PTSD will be assessed with the PTSD Checklist (PCL-5). Participants will rate how bothered they have been in the past month for 20 items where each is scored from 0 to 4, where 0=Not at all to 4=Extremely. The range of scores is 0 to 80, and higher scores are associated with higher PTSD symptoms.	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	The Life Events Checklist for DSM-5 (LEC-5) will be used to assess traumatic life events. It does not have a formal scoring protocol or interpretation, other than to identify if a person has experienced any of the listed events. The LEC-5 does not provide a total or composite score.	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment feasibility	Recruitment feasibility is defined as the percent of eligible participants who enroll in the study.	Throughout the study (on average 10 months for each participant). Outcome will be assessed for each participant one time at the start of the study.
Retention	Retention is defined as the number of participants who completed all study visits and follow-up assessments.	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
Fidelity	Fidelity is defined by the adherence and competence scores (0 to 10) from research staff assessment of audio recorded sessions. Higher scores are associated with greater fidelity.	Throughout the intervention (on average 3 months for each participant). Outcome will be assessed every 1 week during the intervention.
Provider perception of participant satisfaction	Defined as the satisfaction of the participant in the session's helpfulness, enjoyment and relevance (0 to 10), with higher scores being associated with greater satisfaction.	Throughout the intervention (on average 3 months for each participant). Outcome will be assessed every 1 week during the intervention.
Provider perception of participants' future use	Defined as participants' plans to use material learned in the future (Yes/No)	Throughout the intervention (on average 3 months for each participant). Outcome will be assessed every 1 week during the intervention.
Participant perception of participant satisfaction	Defined as direct participant report of their satisfaction of the session's helpfulness, enjoyment and relevance (0 to 10), with higher scores being associated with greater satisfaction.	Throughout the intervention (on average 3 months for each participant). Outcome will be assessed every 1 week during the intervention.
Participant perception of future use	Defined as participants' plans to use material learned in the future (Yes/No)	Throughout the intervention (on average 3 months for each participant). Outcome will be assessed every 1 week during the intervention.

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Haley Carroll, PhD MS, Boston Medical Center, BUCA School of Medicine

Publications and helpful links

General Publications

• Carroll HA, Guevara T, Gamarra P, Mukunta C, Dorsey S, Gelaye B, Henderson D, Bird MD, Frier LF. Protocol for a randomized pilot trial of COMPASS, an open source, culturally adapted cognitive behavioral therapy program for forcibly displaced Venezuelan adults in Peru. medRxiv [Preprint]. 2026 Mar 25:2026.03.19.26348265. doi: 10.64898/2026.03.19.26348265.
• Carroll HA, Guevara T, Gamarra P, Mukunta C, Dorsey S, Gelaye B, Henderson D, Bird MD, Freier LF. Protocol for a randomized pilot trial of COMPASS, an open-source, culturally adapted cognitive behavioral therapy program for forcibly displaced Venezuelan adults in Peru. PLoS One. 2026 Apr 24;21(4):e0345837. doi: 10.1371/journal.pone.0345837. eCollection 2026.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: October 7, 2024
• First Submitted That Met QC Criteria: October 8, 2024
• First Posted (Actual): October 10, 2024

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Feasibility; Acceptability; Culturally adapted; Venezuelan migrants; Cognitive behavioral intervention (CBT); Lay providers
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Stress Disorders, Traumatic; Behavior; Anxiety Disorders; Depression; Stress Disorders, Post-Traumatic; Investigative Techniques; Methods
• Other Study ID Numbers: H-45280; 1K23MH127308 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No