NCT06988332

Problem Management Plus (PM+) in Chile: a Pilot Randomized Controlled Trial of a Psychological Transdiagnostic Intervention Delivered in Primary Health Care

A Pilot, Single-blind, Randomized Controlled Trial Evaluating the Implementation Outcomes and Preliminary Efficacy of Problem Management Plus (PM+) Versus Treatment as Usual in Adult Primary Care Users With Symptoms of Depression and/or Anxiety

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: University of Chile · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the implementation outcomes of a pilot randomized controlled trial and to assess the preliminary efficacy of Problem Management Plus (PM+) in reducing symptoms of depression and anxiety among users at a Primary Health Care center in Chile. Two intervention groups will be compared: PM+ versus care as usual (CAU). The process will include an evaluation of the feasibility of the study procedures, as well as the acceptability and fidelity of the PM+ intervention.

Detailed description

In Chile, only 19% of the population with mental health conditions has access to primary care services, highlighting the urgent need to expand mental health care availability. Training more healthcare professionals to deliver low-intensity psychological interventions could be a valuable approach to addressing this disparity. The World Health Organization's Problem Management Plus (PM+) is a low-intensity, transdiagnostic, peer-delivered intervention designed for implementation in resource-limited settings to address common mental health disorders. In this context, PM+ serves as an evidence-based strategy that can help reduce gaps in healthcare services, particularly regarding availability and accessibility. This study aims to evaluate the implementation outcomes of a pilot randomized clinical trial, including feasibility, acceptability and fidelity and to assess the preliminary efficacy of PM+ in reducing mental health symptoms among users at a primary healthcare center in Chile. The study design is a single-blind pilot randomized controlled trial with a 1:1 allocation ratio, assessing two intervention arms for participants with depressive and/or anxiety symptoms over five weeks. The study population consists of adults of 18 years or above with mild to moderate depressive and/or anxiety symptoms, living in the selected study region and enrolled in the primary health care center chosen to conduct the trial. Two groups will be compared. The treatment group will receive five sessions of PM+. The control group will receive care as usual (CAU), which includes the regular mental health services provided at the primary health care center selected for the study. Implementation outcomes of PM+ will be assessed, focusing mainly on feasibility, acceptability and fidelity. Additionally, preliminary efficacy outcomes of depression, anxiety and self-identified problems will be evaluated.

Conditions

• Anxiety Disorders
• Depressive Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Problem Management Plus (PM+)	Problem Management Plus (PM+) will be delivered according to the Spanish version of the WHO protocol (OMS, 2016). PM+ is a low-intensity, transdiagnostic psychological intervention based on Cognitive Behavioral Therapy (CBT). The protocol incorporates evidence-based strategies, including problem-solving, stress management, behavioral activation, and accessing social support. The intervention consists of five individual 90-minute sessions provided by healthcare professionals without previous expertise in mental health care (WHO, 2018). PM+ helpers will be supervised by master trainers specifically trained for Chile. Two systematic reviews have demonstrated the effectiveness of PM+ in reducing symptoms of common mental disorders, such as depression and anxiety (Schäfer et al., 2023) and specific symptoms of post-traumatic stress (Akhtar et al., 2022).

Timeline

• Start date: 2025-05-09
• Primary completion: 2025-09-12
• Completion: 2025-10-12
• First posted: 2025-05-23
• Last updated: 2025-11-20

Locations

1 site across 1 country: Chile