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Protocol for COMPASS CBT pilot trial in forcibly displaced Venezuelan adults in PeruFirst pilot trial tests new therapy for displaced Venezuelans in Peru

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Key Takeaway
Note this protocol outlines a pilot trial for COMPASS CBT in displaced Venezuelans; results are pending.

The study is a protocol for a randomized pilot trial conducted in Peru involving forcibly displaced Venezuelan adults. The population consists of n = 90 participants. The intervention is COMPASS (Cognitive-behavioral Open-source Mental-health Program Adapted for migrants, Sustainably delivered by lay providers and Supported by evidence), a transdiagnostic, open-source cognitive behavioral therapy program delivered by lay providers via 6-12 weekly remote sessions. The comparator is not reported in the protocol. Follow-up assessments are planned at 3- and 6-month intervals.

Primary outcomes include changes in anxiety, depression, and PTSD symptoms. Secondary outcomes assess feasibility regarding recruitment, retention, and fidelity, as well as acceptability through therapist and participant ratings. Safety data, including adverse events, serious adverse events, discontinuations, and tolerability, are not reported as the study is a protocol.

Key limitations include the fact that the study is a protocol and results are not yet reported. Funding or conflicts of interest are not reported. The study represents the first effectiveness evaluation of an open-source, lay-delivered CBT program tailored for forcibly displaced people in Peru. Findings will inform feasibility, acceptability, and preliminary effectiveness but do not yet establish efficacy.

Practice relevance suggests potential to expand scalable, culturally relevant mental health services for forcibly displaced populations in resource-constrained settings worldwide. Clinicians should interpret this as a plan for future evaluation rather than current evidence of benefit.

Forcibly displaced Venezuelans in Peru often face severe anxiety, depression, and post-traumatic stress disorder. These conditions can feel overwhelming when you have lost your home and safety. Now, a new plan aims to help. Researchers are setting up a pilot trial to test a specific therapy called COMPASS. This program uses cognitive behavioral therapy, which helps people change unhelpful thought patterns, delivered by community members rather than doctors. The sessions happen remotely over six to twelve weeks. The goal is to see if this approach works for people who have been forced to leave their homes.

The study plans to enroll ninety adults. It will track changes in their symptoms of anxiety, depression, and PTSD. The team also wants to know if the program is feasible, meaning it can actually be run in this setting. They will ask participants and therapists if the therapy feels acceptable and easy to use. Follow-ups will happen at three and six months to see if the benefits last.

Right now, this is only a protocol, which is a detailed plan for a study. The actual results are not yet available. Because the study has not finished, we do not yet know if the therapy reduces symptoms or if it is safe. However, the design looks promising for expanding mental health services in resource-constrained settings worldwide. If successful, this could bring culturally relevant help to many displaced people who currently lack access to care.

What this means for you:
This pilot trial will test a new, low-cost therapy for mental health issues in displaced Venezuelans in Peru.

Study Details

Study typeRct
EvidenceLevel 2
Follow-up2.8 mo
PublishedJan 2026
View Original Abstract ↓
Task-sharing approaches have shown promise in low-resource settings, yet few culturally adapted interventions have been systematically evaluated for forcibly displaced populations. Since 2016, over 1.7 million Venezuelans have migrated to Peru, facing significant barriers to healthcare and elevated risks of anxiety, depression, and post-traumatic stress disorder (PTSD). This protocol describes COMPASS (Cognitive-behavioral Open-source Mental-health Program Adapted for migrants, Sustainably delivered by lay providers and Supported by evidence). COMPASS is a transdiagnostic, open-source cognitive behavioral therapy program co-designed with forcibly displaced populations. This protocol describes the procedures for an ongoing randomized pilot trial with n = 90 forcibly displaced Venezuelan people (Clinicaltrials.gov: NCT06635486). COMPASS guides, or lay providers, trained through an intensive apprenticeship model, will deliver 6-12 weekly remote sessions. Primary outcomes include changes in anxiety, depression, and PTSD symptoms, assessed with validated Spanish-language measures. Secondary outcomes include feasibility (recruitment, retention, fidelity) and acceptability (therapist and participant ratings). Exploratory outcomes will examine integration, migration experiences, and demographic moderators of intervention effectiveness. Analyses will follow the intention-to-treat principle, using descriptive statistics and regression models to evaluate symptom trajectories across baseline, post-intervention, and 3- and 6-month follow-ups. This study represents the first effectiveness evaluation of an open-source, lay-delivered CBT program tailored for forcibly displaced people in Peru. Findings will inform feasibility, acceptability, and preliminary effectiveness of COMPASS, with potential to expand scalable, culturally relevant mental health services for forcibly displaced populations in resource-constrained settings worldwide.
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