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

NCT06988332 | Completed

• 1 other identifier: 390
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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 \[SD\]).

  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.

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

Secondary Outcomes (3)

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

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

Study Arms (2)

Problem Management Plus (PM+)

EXPERIMENTAL

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 (CAU)

NO INTERVENTION

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

Interventions

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).

Problem Management Plus (PM+)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chile: lead
• Pan American Health Organization: collaborator

Study Sites (1)

CESFAM Las Ánimas

Valdivia, Chile

Location

Related Publications (2)

• 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.

  PMID: 37713578 RESULT

• 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.

  PMID: 34752690 RESULT

Related Links

• Link to the Spanish version of the WHO Problem Management Plus (PM+) protocol.
• Link to the English version of the WHO Problem Management Plus (PM+) protocol.

MeSH Terms

Conditions

Anxiety Disorders; Depressive Disorder

Condition Hierarchy (Ancestors)

Mental Disorders; Mood Disorders

Study Officials

• Camila A. Solís, MSc.

  University of Chile

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 23, 2025
• Study Start: May 9, 2025
• Primary Completion: September 12, 2025
• Study Completion: October 12, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)