Clinical trial NCT06988332: Problem Management Plus (PM+) in Chile: a Pilot Randomized Controlled Trial of a Psychological Transdiagnostic Intervention Delivered in Primary Health Care
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety Disorders
Depressive Disorder
Keywords: Common mental health disorders
Common mental health problems
Depressive disorder
Anxiety disorders
Pilot Randomised Controlled Trial
Pilot RCT
PM+
Problem Management Plus
Lead sponsor: University of Chile
Sponsor class: OTHER
Collaborators: name: Pan American Health Organization
First posted: 2025-05-23
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Implementation outcome: Feasibility
timeFrame: 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.
measure: Implementation outcome: Acceptability
timeFrame: Acceptability outcomes will be collected during the post-intervention assessment at week 6, starting from the first intervention week.
measure: Implementation Outcome: Fidelity
timeFrame: Fidelity outcomes will be collected throughout the intervention period, from the first to the final intervention week (week 5).
Secondary outcomes:
measure: Preliminary pre-to-post effect of PM+ on depressive symptoms.
timeFrame: Measured through baseline at week 0 and post-intervention assessment at week 6, starting from the first intervention week.
measure: Preliminary pre-to-post effect of PM+ on anxiety symptoms.
timeFrame: Measured through baseline at week 0 and post-intervention assessment at week 6, starting from the first intervention week.
measure: Preliminary pre-to-post effect of PM+ on self-identified problems.
timeFrame: Measured through baseline at week 0 and post-intervention assessment at week 6, starting from the first intervention week.
Other outcomes:
Locations:
city: Valdivia
country: Chile
facility: CESFAM Las Ánimas
Study officials:
affiliation: University of Chile
name: Camila A. Solís, MSc.
role: STUDY_CHAIR
References:
citation: Schafer SK, Thomas LM, Lindner S, Lieb K. World Health Organization's low-intensity psychosocial interventions: a systematic review and meta-analysis of the effects of Problem Management Plus and Step-by-Step. World Psychiatry. 2023 Oct;22(3):449-462. doi: 10.1002/wps.21129.
citation: Akhtar A, Koyiet P, Rahman A, Schafer A, Hamdani SU, Cuijpers P, Sijbrandij M, Bryant RA. Residual posttraumatic stress disorder symptoms after provision of brief behavioral intervention in low- and middle-income countries: An individual-patient data meta-analysis. Depress Anxiety. 2022 Jan;39(1):71-82. doi: 10.1002/da.23221. Epub 2021 Nov 9.