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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-09

Study Completion Date

2025-10-12

Brief Summary

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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.

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Detailed Description

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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

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Anxiety Disorders Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Problem Management Plus (PM+)

PM+ is delivered in five individual sessions conducted by trained healthcare professionals without previous expertise in mental health care.

Group Type EXPERIMENTAL

Problem Management Plus (PM+)

Intervention Type BEHAVIORAL

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).

Care as Usual (CAU)

Care as usual comprises the mental health services currently provided to Primary Health Care users in Chile.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Individuals over 18 years old.
* Diagnosed with or presenting depressive and/or anxiety symptoms (through screening).
* Residents of the selected study region.
* Part of the population enrolled and validated in the pilot primary health care facilities.

Exclusion Criteria

* Suicidal risk requiring immediate or urgent referral to care services.
* Suffering from severe psychiatric disorders or substance use disorders.
* Being in situations of declared risk that require protection (e.g., domestic violence).
* Moderate or severe disability.
* Incapacitating medical illnesses.
* Receiving other mental health treatments that could lead to over-intervention.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No