Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06635486
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
Improving Mental Health in Forcibly Displaced Populations
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Adaptation of an Open Source Cognitive Behavioral Treatment Protocol Designed to Improve Mental Health in Forcibly Displaced Populations
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 homesThis 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
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 homesThis 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None