About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

have Venezuelan nationality

have arrived in Lima in years 2014 to the present

be 18 years of age or older

score 10 points or more at the Patient Health Questionnaire (PHQ-9) or

Disqualifiers

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?"

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

90 Participants

are divided into 2 treatment groups

Group A: Intervention armExperimental treatment 1 intervention

Group B: Wait list control armNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

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

2

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.

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

3

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.

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

4

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.

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

Secondary outcomes

1

Recruitment feasibility

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

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.

2

Retention

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

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

3

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.

Time frame

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

4

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.

Time frame

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

Improving Mental Health in Forcibly Displaced Populations

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts