Protocol for a randomized pilot trial of COMPASS, an open‑source, culturally adapted cognitive behavioral therapy program for forcibly displaced Venezuelan adults in Peru

Clinical Snapshot

Key Findings

• P Value: Not available - protocol stage

• Effect Size: Not available - protocol stage

• Primary Outcome: Changes in anxiety, depression, and PTSD symptoms (protocol - no results yet)

• Nnt Or Sensitivity: Not available - protocol stage

• Confidence Interval: Not available - protocol stage

Clinical Application

Lay provider model and remote delivery enhance feasibility in resource-constrained settings, though requires initial training investment Highly relevant to Australia's refugee and asylum seeker populations. Could inform culturally adapted mental health services under Medicare or state-funded programs, particularly for remote/regional areas Forcibly displaced adults, particularly Venezuelan migrants, with anxiety, depression, or PTSD symptoms

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.

References

1. 1.Carroll, H. A., Guevara, T., Gamarra, P., Mukunta, C., Dorsey, S., Gelaye, B., Henderson, D., Bird, M. D., & Freier, L. F. (2026). 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. https://doi.org/10.1371/journal.pone.0345837