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NCT Number: NCT06635486

Improving 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.

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Key information

Conditions

Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Post Traumatic Stress Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad del Pacifico

Lima, Peru

Location status: Recruiting

About this study

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:

  • Efficacy: To determine if the intervention effectively reduces symptoms of anxiety, depression, and PTSD among participants.
  • Feasibility and Acceptability: To evaluate how practical and well-received the intervention is by both participants and providers.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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?"

Treatment and study plan

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.

Other names: A culturally adapted transdiagnostic CBT intervention

Primary outcomes

  1. Anxiety

    Time frame: 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

    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.

  2. Depression

    Time frame: 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 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.

  3. Post Traumatic Stress Disorder (PTSD)

    Time frame: 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

    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.

  4. Traumatic Life Events

    Time frame: 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

    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.

Secondary outcomes

  1. Recruitment feasibility

    Time frame: 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.

    Recruitment feasibility is defined as the percent of eligible participants who enroll in the study.

  2. Retention

    Time frame: 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

    Retention is defined as the number of participants who completed all study visits and follow-up assessments.

  3. Fidelity

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

    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.

  4. Provider perception of participant satisfaction

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

    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.

  5. Provider perception of participants' future use

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

    Defined as participants' plans to use material learned in the future (Yes/No)

  6. Participant perception of participant satisfaction

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

    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.

  7. Participant perception of future use

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

    Defined as participants' plans to use material learned in the future (Yes/No)

Study contacts

Contact information is provided by the study sponsor or research team.

Haley Carroll, PhD MS

CONTACT

[email protected]

617 414 2035

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 10, 2024
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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