An interventional study of Problem Management Plus (PM+) in Anxiety Disorders and Depressive Disorder, sponsored by University of Chile. Completed at 1 site in Chile. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-20.
Sponsored by University of Chile · Not applicable, Interventional, and Treatment
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.
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 56 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →University of Chile is the lead sponsor of 191 studies on the registry; 36 are open to participants now.
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Exclusion Criteria:
PM+ is delivered in five individual sessions conducted by trained healthcare professionals without previous expertise in mental health care.
Behavioral: Problem Management Plus (PM+)
Care as usual comprises the mental health services currently provided to Primary Health Care users in Chile.
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).
Implementation outcome: Feasibility
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.
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.
Implementation outcome: Acceptability
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 \[SD\]).
Time frame: Acceptability outcomes will be collected during the post-intervention assessment at week 6, starting from the first intervention week.
Implementation Outcome: Fidelity
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.
Time frame: Fidelity outcomes will be collected throughout the intervention period, from the first to the final intervention week (week 5).
Preliminary pre-to-post effect of PM+ on depressive symptoms.
Measured using the Patient Health Questionnaire - 9 items (PHQ-9), with scores ranging from 0 to 27. Higher scores indicate increased symptom severity.
Time frame: Measured through baseline at week 0 and post-intervention assessment at week 6, starting from the first intervention week.
Preliminary pre-to-post effect of PM+ on anxiety symptoms.
Measured using the Generalized Anxiety Disorder - 7 item (GAD-7), with scores ranging from 0 to 21. Higher scores indicate increased symptom severity.
Time frame: Measured through baseline at week 0 and post-intervention assessment at week 6, starting from the first intervention week.
Preliminary pre-to-post effect of PM+ on self-identified problems.
Measured using the Psychological Outcome Profiles (PSYCHLOPS), with scores ranging from 0 to 20. Higher scores indicate increased self-identified problem severity.
Time frame: Measured through baseline at week 0 and post-intervention assessment at week 6, starting from the first intervention week.
Plan to share: No — Individual Participant Data (IPD) will only be shared when required by regulatory institutions. In order to protect privacy and ensure the confidentiality of information, all data shared with research staff members without direct access to the case file will identify participants solely by their enrollment number and will be transmitted using depersonalized forms, such as the CRF. In the case it becomes necessary to share IPD with regulatory institutions, such as ethics committees or governmental agencies, the depersonalized enrollment number will be used to maintain the confidentiality of personal information. Personal information will only be shared with public health care services or as required under Chilean legislation.
This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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University of Chile