AnxietyNCT06635486
Improving Mental Health in Forcibly Displaced Populations
A study testing Adapted cognitive-behavioral (CBT) intervention in people with Anxiety and Post Traumatic Stress Disorder, run by Boston Medical Center at 1 site in Peru.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Post Traumatic Stress Disorder, Depression
- What is being tested?
- Adapted cognitive-behavioral (CBT) intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePeru
- Study dates
- 15 Apr 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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?"
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Adaptation of an Open Source Cognitive Behavioral Treatment Protocol Designed to Improve 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.
Read the 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:
- 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.
- Conditions
- Anxiety, Post Traumatic Stress Disorder, Depression
- Being tested
- Adapted cognitive-behavioral (CBT) intervention
- Keywords
- Venezuelan migrants, Cognitive behavioral intervention (CBT), Culturally adapted, Lay providers, Feasibility, Acceptability
- Medical subject headings
- Anxiety Disorders, Stress Disorders, Post-Traumatic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted cognitive-behavioral (CBT) interventionBehavioural
Also called A culturally adapted transdiagnostic CBT intervention
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Participants randomized to this arm will receive the CBT adapted intervention. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Recruitment feasibility is defined as the percent of eligible participants who enroll in the study.
Measured: 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
Retention is defined as the number of participants who completed all study visits and follow-up assessments.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Defined as participants' plans to use material learned in the future (Yes/No)
Measured: Throughout the intervention (on average 3 months for each participant). Outcome will be assessed every 1 week during the intervention.
Participant perception of participant satisfaction
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.
Measured: Throughout the intervention (on average 3 months for each participant). Outcome will be assessed every 1 week during the intervention.
Participant perception of future use
Defined as participants' plans to use material learned in the future (Yes/No)
Measured: Throughout the intervention (on average 3 months for each participant). Outcome will be assessed every 1 week during the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start15 Apr 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to receive the intervention (n = 60) or wait list control (n = 30).
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Haley Carroll, PhD MS, Principal investigator, Boston Medical Center, BUCA School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635486
- Sponsor's protocol ID
- H-45280
- Other IDs
- 1K23MH127308
- Status last verified
- May 2026
- First submitted
- 7 Oct 2024
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carroll HA, Guevara T, Gamarra P, Mukunta C, Dorsey S, Gelaye B, Henderson D, Bird MD, Frier LF. Protocol for a randomized pilot trial of COMPASS, an open source, culturally adapted cognitive behavioral therapy program for forcibly displaced Venezuelan adults in Peru. medRxiv [Preprint]. 2026 Mar 25:2026.03.19.26348265. doi: 10.64898/2026.03.19.26348265.
PubMed 42051574Carroll HA, Guevara T, Gamarra P, Mukunta C, Dorsey S, Gelaye B, Henderson D, Bird MD, Freier LF. Protocol for a randomized pilot trial of COMPASS, an open-source, culturally adapted cognitive behavioral therapy program for forcibly displaced Venezuelan adults in Peru. PLoS One. 2026 Apr 24;21(4):e0345837. doi: 10.1371/journal.pone.0345837. eCollection 2026.
PubMed 42030335
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation of an Open Source Cognitive Behavioral Treatment Protocol Designed to Improve Mental Health in Forcibly Displaced Populations
- ClinicalTrials.gov ID
- NCT06635486
- Acronym / sponsor ID
- H-45280
- Conditions
- Anxiety, Post Traumatic Stress Disorder, Depression
- Keywords
- Venezuelan migrants, Cognitive behavioral intervention (CBT), Culturally adapted, Lay providers, Feasibility, Acceptability
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 10 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to receive the intervention (n = 60) or wait list control (n = 30).
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: Adapted cognitive-behavioral (CBT) interventionParticipants randomized to this arm will receive the CBT adapted intervention. |
| Wait list control arm | No intervention | –Participants randomized to this arm will be placed on a wait list for the CBT adapted intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (4 listed)
- 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?"
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted cognitive-behavioral (CBT) interventionAlso: A culturally adapted transdiagnostic CBT interventionThe 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. | Behavioural | Intervention arm |
Primary outcome
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.
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.
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.
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.
7 secondary outcomes
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.
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
Fidelity
Time frame: 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
Time frame: 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
Time frame: Throughout the intervention (on average 3 months for each participant). Outcome will be assessed every 1 week during the intervention.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Derived from this study: PubMed 42051574Carroll HA, Guevara T, Gamarra P, Mukunta C, Dorsey S, Gelaye B, Henderson D, Bird MD, Frier LF. Protocol for a randomized pilot trial of COMPASS, an open source, culturally adapted cognitive behavioral therapy program for forcibly displaced Venezuelan adults in Peru. medRxiv [Preprint]. 2026 Mar 25:2026.03.19.26348265. doi: 10.64898/2026.03.19.26348265.
- Derived from this study: PubMed 42030335Carroll HA, Guevara T, Gamarra P, Mukunta C, Dorsey S, Gelaye B, Henderson D, Bird MD, Freier LF. Protocol for a randomized pilot trial of COMPASS, an open-source, culturally adapted cognitive behavioral therapy program for forcibly displaced Venezuelan adults in Peru. PLoS One. 2026 Apr 24;21(4):e0345837. doi: 10.1371/journal.pone.0345837. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Haley Carroll, PhD MS principal investigator
Boston Medical Center, BUCA School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted cognitive-behavioral (CBT) intervention in people with Anxiety and Post Traumatic Stress Disorder, run by Boston Medical Center at 1 site in Peru.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haley Carroll, PhD MS (617 414 2035, hcarrol1@bu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06635486, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.