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

This paper outlines the protocol for a randomized pilot trial evaluating the feasibility, acceptability, and preliminary effectiveness of COMPASS, an open-source, culturally adapted cognitive behavioral therapy program delivered by lay providers to forcibly displaced Venezuelan adults in Peru.

The Gist

Imagine a massive wave of people fleeing a storm. Since 2016, over 1.7 million Venezuelans have left their homes due to crisis and arrived in Peru. While they are safe from the immediate danger, they are carrying heavy emotional backpacks filled with anxiety, depression, and trauma from what they've been through.

The problem? Peru's mental health system is like a small, overcrowded clinic with only a few doctors, but thousands of people need help. There simply aren't enough professional therapists to go around.

This paper introduces a new project called COMPASS. Think of COMPASS not as a rigid medical prescription, but as a custom-built map and compass for people lost in a difficult journey.

Here is the simple breakdown of how it works:

1. The Problem: Too Many Travelers, Too Few Guides

Usually, only highly trained doctors can give mental health therapy. But in places with limited resources, this is like trying to fix a broken bridge with only one engineer. The researchers realized they needed a way to train more "guides" quickly without losing quality.

2. The Solution: The "Apprentice" Model

Instead of waiting for years to train new doctors, the COMPASS project uses an apprenticeship model.

• The Guides: They recruit regular community members (lay providers) who don't need to be psychologists. They are like local tour guides who know the terrain.
• The Training: These guides go through an intense 80-hour training course. It's like a "driving school" for mental health, where they learn the rules of the road (therapy techniques) and practice driving with a supervisor before taking passengers.
• The Support: Even after training, these guides have a "co-pilot" (a supervisor) checking their maps every week to make sure they are on the right path.

3. The Tool: A "Swiss Army Knife" Therapy

Most therapy is like a specialized screwdriver; it only works on one specific problem. COMPASS is a Swiss Army Knife.

• It is Transdiagnostic: This means it doesn't matter if you are struggling with sadness, fear, or trauma. The tool kit has the right blade for whatever problem you are facing.
• It is Culturally Adapted: The researchers didn't just translate a manual from English to Spanish. They built the tool with the Venezuelan community. They included local concepts like "Pa'lante" (keep moving forward) and addressed specific struggles like losing your identity or facing discrimination. It's like cooking a recipe that uses local ingredients instead of trying to force foreign spices into a local dish.
• It is Open-Source: Imagine a recipe book that is free for anyone to copy, share, and improve. The COMPASS manual is free, so other countries can use it without paying expensive licensing fees.

4. The Experiment: The Pilot Test

The researchers are currently running a "test drive" with 90 people.

• The Group: They are taking 60 people to get the COMPASS therapy immediately (the "Test Group") and 30 people to wait 12 weeks before getting it (the "Waiting Group").
• The Delivery: The therapy happens over video calls, like a FaceTime session with a friend, because many people work long hours and can't travel to a clinic.
• The Goal: They want to see if the "Test Group" feels better (less anxious, less depressed) than the "Waiting Group." They also want to check if the system is easy to run (feasibility) and if people actually like it (acceptability).

5. Why This Matters

If this works, it's a game-changer. It proves that you don't need a team of elite specialists to heal a community. You just need trained, supported, local people with a good map.

The Big Picture Analogy:
Imagine a forest fire (the mental health crisis). You can't wait for the National Fire Department (specialist doctors) to arrive because they are too far away. COMPASS is about training the local forest rangers (community guides) with the right tools and a clear plan so they can put out the fire right where it's burning.

The Bottom Line:
This paper is a blueprint for a pilot study testing whether a free, flexible, community-led mental health program can help Venezuelan refugees in Peru heal from their trauma. If successful, this "map" could be copied and shared all over the world to help other displaced people find their way.

Technical Summary

Based on the provided preprint, here is a detailed technical summary of the COMPASS pilot trial protocol.

1. Problem Statement

• Global Context: The global population of forcibly displaced people has nearly doubled to 123 million, with approximately 75% relocating to Low- and Middle-Income Countries (LMICs). Forced displacement is a significant risk factor for Common Mental Disorders (CMDs), specifically depression, anxiety, and Post-Traumatic Stress Disorder (PTSD).
• Specific Context: Since 2016, over 1.7 million Venezuelans have been forcibly displaced to Peru due to the humanitarian crisis. Despite legal guarantees of healthcare access, bureaucratic barriers (lack of documentation) and a strained mental health infrastructure limit access to care.
• The Gap: Existing interventions often lack cultural adaptation, are not scalable due to licensing costs, or rely on specialist providers who are scarce in resource-constrained settings. There is a critical need for culturally adapted, open-source, transdiagnostic, and lay-delivered interventions that address the specific migration-related stressors (e.g., migration grief, acculturative stress, discrimination) faced by this population.

2. Methodology

• Study Design: A randomized pilot trial with a Waitlist Control (WLC) design.
  • Sample Size: $N = 90$ forcibly displaced Venezuelan adults in Lima, Peru.
  • Allocation: 60 participants to the Intervention Group; 30 to the WLC group.
  • Randomization: Conducted via REDCap; researchers are blind to the sequence, though participants and guides are not blinded post-randomization.
• Intervention (COMPASS):
  • Full Name: Cognitive-behavioral Open-source Mental-health Program Adapted for migrants, Sustainably delivered by lay providers and Supported by evidence.
  • Theoretical Basis: Co-designed using the Heuristic Framework for Cultural Adaptation, Ecological Validity Model, and Taxonomy of Treatment Components. It is grounded in the principle of "nothing about us, without us," involving displaced populations in the design.
  • Format: Transdiagnostic CBT delivered remotely via weekly 60-minute video calls.
  • Duration: Flexible dosage of 6–12 sessions (including orientation and closing), tailored to symptom severity and specific needs (e.g., adding modules for migration adaptation or problem-solving).
  • Core Components: Behavioral activation, cognitive restructuring, problem-solving, in-vivo/imaginal exposure, and emotion regulation.
  • Cultural Adaptation: Includes specific modules on migration grief, identity reconciliation, and culturally salient coping strategies (e.g., pa'lante and perseverance).
• Providers (COMPASS Guides):
  • Profile: Lay providers (non-specialists) recruited from the community.
  • Training: Intensive 80-hour in-person apprenticeship model, followed by practice groups, supervised practice clients, and continuous weekly peer supervision.
  • Supervision Hierarchy: Guides $\rightarrow$ Supervisors (competent guides) $\rightarrow$ Trainers (local counselors) $\rightarrow$ Principal Investigator.
• Participants:
  • Inclusion: Venezuelan adults (18+), arrived in Lima $\ge$ 2014, meeting provisional criteria for anxiety (GAD-7 $\ge$ 10), depression (PHQ-9 $\ge$ 10), or PTSD (PCL-5 $\ge$ 31 with Criterion A event).
  • Exclusion: Active suicidal/homicidal ideation, lifetime psychosis, or problematic substance use.
• Outcome Measures:
  • Primary: Symptom changes in Anxiety (GAD-7), Depression (PHQ-9), and PTSD (PCL-5) assessed at Baseline (T0), Endline (T1), 3-month (T2), and 6-month (T3) follow-ups.
  • Secondary (Feasibility/Acceptability): Recruitment/retention rates, fidelity (20% of sessions audio-recorded and rated via checklist), and satisfaction ratings (0–10 scale) from both guides and participants.
  • Exploratory: Integration (IPL Index), Migratory Grief (MGLQ), and Perceived Negative Context of Reception (NRC) as moderators.
• Statistical Analysis: Intention-to-treat (ITT) principle using R. Descriptive statistics, regression models for symptom trajectories, and moderation analyses.

3. Key Contributions

• Innovation in Delivery: This is the first study to evaluate an open-source CBT program specifically tailored for forcibly displaced populations, eliminating licensing barriers and enabling scalability.
• Lay Provider Model: It demonstrates a robust apprenticeship model for training non-specialists to deliver complex, transdiagnostic CBT with high fidelity in a resource-constrained setting.
• Co-Design Approach: The intervention was developed with the target population, integrating specific migration-related stressors (grief, identity loss, xenophobia) directly into the therapeutic protocol, rather than just translating existing Western models.
• Transdiagnostic Flexibility: Unlike diagnosis-specific protocols, COMPASS adapts to comorbidities and varying symptom severities by allowing flexible session counts and modular content selection.

4. Results

• Current Status: As of the protocol writing (March 2026), the study is ongoing.
  • Recruitment began in April 2025.
  • Lay provider training and supervision are complete.
  • The first cohort of participants is finishing clinical sessions.
• Outcome Data: No clinical efficacy results are reported in this document as it is a protocol paper. The paper outlines the plan for analyzing effectiveness, feasibility, and acceptability, with data collection expected to conclude in April 2027 and analysis by November 2027.
• Preliminary Feedback: The authors note that preliminary qualitative feedback from guides, participants, and experts indicates the program is well-received, though challenges regarding referral networks and stepped-care options remain.

5. Significance

• Scalability for Global Health: If proven effective, COMPASS offers a blueprint for scalable mental health care for displaced populations worldwide. Its open-source nature allows for free adaptation and implementation by NGOs and governments without licensing fees.
• Addressing the Treatment Gap: By utilizing lay providers, the model directly addresses the shortage of mental health professionals in LMICs and refugee settings.
• Policy and Practice: Findings will inform community leaders, NGOs, and primary healthcare providers in Peru and potentially other Latin American countries hosting Venezuelan migrants. It provides evidence for integrating culturally specific, transdiagnostic interventions into national health systems.
• Open Science: The study commits to making the manual, training materials, and statistical code publicly available on the Open Science Framework (OSF), fostering transparency and replication.

Note: This document is a preprint (posted March 25, 2026) and has not yet undergone peer review. It represents a protocol for a study in progress, not a final report of clinical outcomes.