Improving Mental Health in Forcibly Displaced Populations

NCT06635486 | Recruiting

• 2 other identifiers: H-452801K23MH127308
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Anxiety; Post Traumatic Stress Disorder; Depression

Keywords

Venezuelan migrants; Cognitive behavioral intervention (CBT); Culturally adapted; Lay providers; Feasibility; Acceptability

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• Recruitment feasibility

  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

  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

  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

  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

  Throughout the intervention (on average 3 months for each participant). Outcome will be assessed every 1 week during the intervention.

Study Arms (2)

Intervention arm

EXPERIMENTAL

Participants randomized to this arm will receive the CBT adapted intervention.

Behavioral: Adapted cognitive-behavioral (CBT) intervention

Wait list control arm

NO INTERVENTION

Participants randomized to this arm will be placed on a wait list for the CBT adapted intervention.

Interventions

Adapted cognitive-behavioral (CBT) intervention BEHAVIORAL

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.

Also known as: A culturally adapted transdiagnostic CBT intervention

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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?"

Sponsors & Collaborators

• Boston Medical Center: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Universidad del Pacifico

Lima, Peru

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Stress Disorders, Post-Traumatic; Depression

Interventions

Methods

Condition Hierarchy (Ancestors)

Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Haley Carroll, PhD MS

  Boston Medical Center, BUCA School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haley Carroll, PhD MS

CONTACT

617 414 2035; hcarrol1@bu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to receive the intervention (n = 60) or wait list control (n = 30).

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 10, 2024
• Study Start: April 15, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

PE (1)