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Completed

NCT Number: NCT06988332

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

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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Key information

Conditions

Anxiety Disorders Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CESFAM Las Ánimas

Valdivia, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Problem Management Plus (PM+)

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).

Primary outcomes

  1. Implementation outcome: Feasibility

    Time frame: Feasibility outcome component A will be collected once recruitment is completed. Component B will be collected at week 6, starting from the first intervention week.

    Measured through components A and B. A. Percentage of participant recruitment: defined as the proportion of participants who consented to enroll in the trial and were subsequently recruited.

    B. Participant adherence to PM+: defined as the average number of PM+ sessions attended by each participant.

  2. Implementation outcome: Acceptability

    Time frame: Acceptability outcomes will be collected during the post-intervention assessment at week 6, starting from the first intervention week.

    Indicators of PM+ acceptability among users and trained facilitators, assessed with quantitative scales. For users, an adapted version of the Abbreviated Acceptability Rating Profile (AARP) will be administered. The AARP consists of 8 Likert-scale items, yielding total scores ranging from 8 to 48, with higher scores indicating greater acceptability. For facilitators, an adapted version of the Acceptability of Intervention Measure (AIM) will be used. The AIM comprises 5 Likert-scale items, producing scores ranging from 4 to 20, where higher scores reflect greater acceptability. For both measures, descriptive statistics will be reported using median and interquartile range (IQR), as well as mean and standard deviation (x̄ [SD]).

  3. Implementation Outcome: Fidelity

    Time frame: Fidelity outcomes will be collected throughout the intervention period, from the first to the final intervention week (week 5).

    Indicators of PM+ fidelity will be assessed with a study-specific rubric developed based on expert judgement. The rubric consists of 5 items, each reflecting a component of proper PM+ delivery. Items range from 1 ("low fidelity") to 4 ("high fidelity"), with higher scores indicating greater fidelity. The reported statistics will include the median and interquartile range (IQR) for each item, and the mean and standard deviation (x̄ [SD]) for the overall fidelity score per assessed PM+ session.

Secondary outcomes

  1. Preliminary pre-to-post effect of PM+ on depressive symptoms.

    Time frame: Measured through baseline at week 0 and post-intervention assessment at week 6, starting from the first intervention week.

    Measured using the Patient Health Questionnaire - 9 items (PHQ-9), with scores ranging from 0 to 27. Higher scores indicate increased symptom severity.

  2. Preliminary pre-to-post effect of PM+ on anxiety symptoms.

    Time frame: Measured through baseline at week 0 and post-intervention assessment at week 6, starting from the first intervention week.

    Measured using the Generalized Anxiety Disorder - 7 item (GAD-7), with scores ranging from 0 to 21. Higher scores indicate increased symptom severity.

  3. Preliminary pre-to-post effect of PM+ on self-identified problems.

    Time frame: Measured through baseline at week 0 and post-intervention assessment at week 6, starting from the first intervention week.

    Measured using the Psychological Outcome Profiles (PSYCHLOPS), with scores ranging from 0 to 20. Higher scores indicate increased self-identified problem severity.

Sponsors and collaborators

Lead sponsor

University of Chile

Other

Collaborators

  • Pan American Health Organization

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 23, 2025
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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