Clinical trial NCT06635486: Improving Mental Health in Forcibly Displaced Populations
Official title: Adaptation of an Open Source Cognitive Behavioral Treatment Protocol Designed to Improve Mental Health in Forcibly Displaced Populations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Post Traumatic Stress Disorder
Depression
Keywords: Venezuelan migrants
Cognitive behavioral intervention (CBT)
Culturally adapted
Lay providers
Feasibility
Acceptability
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-10-10
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to receive the intervention (n = 60) or wait list control (n = 30).
Primary purpose: TREATMENT

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.

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.

Eligibility 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?"

Primary outcomes:
measure: Anxiety
timeFrame: 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
measure: Depression
timeFrame: 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
measure: Post Traumatic Stress Disorder (PTSD)
timeFrame: 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
measure: Traumatic Life Events
timeFrame: 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:
measure: Recruitment feasibility
timeFrame: 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.
measure: Retention
timeFrame: 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
measure: Fidelity
timeFrame: Throughout the intervention (on average 3 months for each participant). Outcome will be assessed every 1 week during the intervention.
measure: Provider perception of participant satisfaction
timeFrame: Throughout the intervention (on average 3 months for each participant). Outcome will be assessed every 1 week during the intervention.
measure: Provider perception of participants' future use
timeFrame: Throughout the intervention (on average 3 months for each participant). Outcome will be assessed every 1 week during the intervention.
measure: Participant perception of participant satisfaction
timeFrame: Throughout the intervention (on average 3 months for each participant). Outcome will be assessed every 1 week during the intervention.
measure: Participant perception of future use
timeFrame: Throughout the intervention (on average 3 months for each participant). Outcome will be assessed every 1 week during the intervention.
Other outcomes:
Locations:
city: Lima
country: Peru
facility: Universidad del Pacifico
Study officials:
affiliation: Boston Medical Center, BUCA School of Medicine
name: Haley Carroll, PhD MS
role: PRINCIPAL_INVESTIGATOR
References: